Medical Cannabis Seeds Near Me

Questions and answers about FDA regulation of cannabis and cannabis-derived products TITLE 16 (a) Marijuana’s recorded use as a medicine goes back nearly 5,000 years. Modern medical research has confirmed the beneficial uses for marijuana in treating or alleviating the pain,

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

FDA Communications

Regulatory Resources

Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

1. What are cannabis and marijuana?

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.

2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?

A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).

FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?

A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.

Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

8. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

9. Can THC or CBD products be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.

These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)

FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

15. Can I import or export cannabis-containing or cannabis-derived products?

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).

Research and Expanded Access

16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.

Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:

  • For a Schedule I controlled substance under the CSA, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site cannabis will be studied.
  • NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.
  • Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.

17. Does the FDA object to the clinical investigation of cannabis for medical use?

A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:

  1. Providing information on the process needed to conduct clinical research using cannabis.
  2. Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
  3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
  4. Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.
See also  Montreal Cannabis Seeds

18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?

A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.

Children and Pregnant/Lactating Women

20. Does the FDA have concerns about administering a cannabis product to children?

A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?

A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. [7] Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.

22. What does the FDA think about making CBD available to children with epilepsy?

A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

23. What should I do if my child eats something containing cannabis?

A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.

Pets and other Animals

24. I’ve seen cannabis products being marketed for pets. Are they safe?

A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.

Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.

If you have concerns that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

25. Can hemp be added to animal food?

A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.

With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.

In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

[2] Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.

[3] Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.

[4] Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.

[5] Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.

[6] Campolongo, et al. Perinatal exposure to delta-9-tetrahydrocannabinol causes enduring cognitive deficits associated with alteration of cortical gene expression and neurotransmission in rats. Addict Biol 2007; 12(3-4): 485–495.

TITLE 16

(a) Marijuana’s recorded use as a medicine goes back nearly 5,000 years. Modern medical research has confirmed the beneficial uses for marijuana in treating or alleviating the pain, nausea, and other symptoms associated with a variety of debilitating medical conditions, including cancer, multiple sclerosis, and HIV/AIDS, as found by the National Academy of Sciences’ Institute of Medicine in March 1999.

(b) Studies published since the 1999 Institute of Medicine report have continued to show the therapeutic value of marijuana in treating a wide array of debilitating medical conditions. These include relief of the neuropathic pain caused by multiple sclerosis, HIV/AIDS, and other illnesses that often fails to respond to conventional treatments and relief of nausea, vomiting, and other side effects of drugs used to treat HIV/AIDS and hepatitis C, increasing the chances of patients continuing on life-saving treatment regimens. Specifically, in February 2010, the Center for Medicinal Cannabis Research released a lengthy report that summarized 15 recent studies clearly demonstrating marijuana’s medical efficacy for a broad range of conditions. These studies, many of which were double blind, placebo-controlled trials, included neuropathic pain trials published in the Journal of Pain, Neuropsychopharmacology and Neurology , a study on the analgesic efficacy of smoked marijuana published in Anesthesiology , a study on the mechanisms of cannabinoid analgesia in rats published in Pain , and a study on vaporization as a “smokeless” marijuana delivery system published in Clinical Pharmacology & Therapeutics .

(c) Marijuana has many currently accepted medical uses in the United States, having been recommended by thousands of licensed physicians to at least 350,000 patients in states with medical marijuana laws. Marijuana’s medical utility has been recognized by a wide range of medical and public health organizations, including the American Academy of HIV Medicine, the American College of Physicians, the American Nurses Association, the American Public Health Association and the Leukemia and Lymphoma Society.

(d) Data from the Federal Bureau of Investigation’s Uniform Crime Reports and the Compendium of Federal Justice Statistics show that approximately 99 out of every 100 marijuana arrests in the U.S. are made under state law, rather than under federal law. Consequently, changing state law will have the practical effect of protecting from arrest the vast majority of seriously ill patients who have a medical need to use marijuana.

(e) Alaska, Arizona, California, Colorado, the District of Columbia, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, New Jersey, Oregon, Vermont, Rhode Island, and Washington have removed state-level criminal penalties from the medical use of marijuana. Delaware joins in this effort for the health and welfare of its citizens.

(f) States are not required to enforce federal law or prosecute people for engaging in activities prohibited by federal law. Therefore, compliance with this chapter does not put the State of Delaware in violation of federal law.

(g) State law should make a distinction between the medical and nonmedical uses of marijuana. Hence, the purpose of this chapter is to protect patients with debilitating medical conditions, as well as their health-care practitioners and providers, from arrest and prosecution, criminal and other penalties, and property forfeiture if such patients engage in the medical use of marijuana.

For purposes of this chapter:

(1) “Cannabidiol-rich medical marijuana” or “CBD-rich” means a marijuana strain or product formulization that has elevated levels of cannabidiol (“CBD”) and contains the profile of CBD and tetrahydrocannabinol (“THC”) concentrations approved by the Department, based upon the recommendation of the Medical Marijuana Act Oversight Committee.

(2) “Cardholder” means a qualifying patient or a designated caregiver who has been issued and possesses a valid registry identification card.

(3) “Compassion center agent” means a principal officer, board member, employee, or agent of a registered compassion center who is 21 years of age or older and has not been convicted of an excluded felony offense or drug misdemeanor within 5 years.

(4) “Debilitating medical condition” means 1 or more of the following:

a. Terminal illness, cancer, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, decompensated cirrhosis, amyotrophic lateral sclerosis, agitation of Alzheimer’s disease, post-traumatic stress disorder, intractable epilepsy, seizure disorder, glaucoma, chronic debilitating migraines, new daily persistent headache, or the treatment of these conditions.

b. A chronic or debilitating disease or medical condition or its treatment that produces 1 or more of the following: cachexia or wasting syndrome; severe, debilitating pain that has not responded to previously prescribed medication or surgical measures for more than 3 months or for which other treatment options produced serious side effects; intractable nausea; seizures; severe and persistent muscle spasms, including those characteristic of multiple sclerosis.

c. Any other medical condition or its treatment added by the Department, as provided for in § 4906A of this title.

(5) “Department” means the Delaware Department of Health and Social Services or its successor agency.

(6) “Designated caregiver” means a person who:

a. Is at least 21 years of age unless the person is the parent or legal guardian of a minor who is a qualifying patient;

b. Has agreed to assist with a patient’s medical use of marijuana;

c. Has not been convicted of an excluded felony offense; and

d. Assists no more than 5 qualifying patients with their medical use of marijuana.

(7) “Enclosed, locked facility” means a greenhouse, building, or other enclosed area equipped with locks or other security devices that is on a registered compassion center’s property and permits access only the compassion center agents working for the registered compassion center.

(8) “Excluded felony offense” means:

a. A violent crime defined in § 4201(c) of Title 11, that was classified as a felony in the jurisdiction where the person was convicted; or

b. A violation of a state or federal controlled substance law that was classified as a felony in the jurisdiction where the person was convicted, not including:

1. An offense for which the sentence, including any term of probation, incarceration, or supervised release, was completed 10 or more years earlier; or

2. An offense that consisted of conduct for which this chapter would likely have prevented a conviction, but the conduct either occurred prior to July 1, 2011, or was prosecuted by an authority other than the State of Delaware.

(9) “Health-care practitioner” means an individual who is licensed and authorized to write medical orders under Title 24 as a physician, advanced practice registered nurse, or physician assistant, except as otherwise provided in this paragraph. If the qualifying patient is younger than 18 years of age, the health-care practitioner must be a physician who is a pediatric neurologist, pediatric gastroenterologist, pediatric oncologist, pediatric psychiatrist, developmental pediatrician, or pediatric palliative care specialist.

(10) “Intractable epilepsy” means an epileptic seizure disorder for which standard medical treatment does not prevent or significantly ameliorate recurring, uncontrolled seizures or for which standard medical treatment results in harmful side effects.

(11) “Marijuana” has the meaning given that term in § 4701 of this title.

(12) “Medical marijuana oil” means any of the following:

a. Cannabidiol oil’’ which is a processed Cannabis plant extract that contains at least 15% cannabidiol but no more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of cannabidiol per milliliter but not more than 7% tetrahydrocannabinol.

b. “THC-A oil” which is a processed Cannabis plant extract that contains at least 15% tetrahydrocannabinol acid but not more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of tetrahydrocannabinol acid per milliliter but not more than 7% tetrahydrocannabinol.

c. Any change in the oil formulation which is made by the Department based upon the recommendation of the Medical Marijuana Act Oversight Committee.

(13) “Medical use” means the acquisition; administration; delivery; possession; transportation; transfer; transportation; or use of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a registered qualifying patient’s debilitating medical condition or symptoms associated with the patient’s debilitating medical condition.

(14) “Physician” means a properly licensed physician subject to Chapter 17 of Title 24 except as otherwise provided in this paragraph. If the qualifying patient is younger than 18 years of age, the physician must be a pediatric neurologist, pediatric gastroenterologist, pediatric oncologist or pediatric palliative care specialist.

(15) “Qualifying patient” means an individual who meets the qualifications to receive a registry identification card under this chapter.

(16) “Registered compassion center” means a not-for-profit entity registered pursuant to § 4914A of this title that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, sells, supplies, or dispenses marijuana, paraphernalia, or related supplies and educational materials to registered qualifying patients who have designated the dispenser to cultivate marijuana for their medical use and the registered designated caregivers of these patients.

(17) “Registered safety compliance facility” means a nonprofit entity registered under § 4915A of this title by the Department to provide 1 or more of the following services: testing marijuana produced for medical use for potency and contaminants; and training cardholders and prospective compassion center agents. The training may include, but need not be limited to, information related to 1 or more of the following:

a. The safe and efficient cultivation, harvesting, packaging, labeling, and distribution of marijuana;

b. Security and inventory accountability procedures; and

c. Up-to-date scientific and medical research findings related to medical marijuana.

(18) “Registry identification card” means a document issued by the Department that identifies a person as 1 of the following:

a. A registered qualifying adult patient.

b. A registered designated caregiver for a qualifying adult patient.

c. A registered designated caregiver for a pediatric patient.

d. A registered compassionate use adult patient.

e. A registered designated caregiver for an adult compassionate use patient.

f. A registered designated caregiver for a pediatric compassionate use patient.

g. A registered CBD-rich patient.

h. A registered designated caregiver for a CBD-rich patient.

(19) “Safety compliance facility agent” means a principal officer, board member, employee, or agent of a registered safety compliance facility who is 21 years of age or older and has not been convicted of an excluded felony offense.

(20) “Terminal illness” means any disease, illness or condition sustained by any human being:

a. For which there is no reasonable medical expectation of recovery;

b. Which, as a medical probability, will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life processes; and

c. As a result of which, the human being’s health-care practitioner would not be surprised if death were to occur within 12 months.

(21) “Usable marijuana” means the dried leaves and flowers of the marijuana plant and any mixture or preparation of those dried leaves and flowers, including but not limited to tinctures, ointments, other preparations including medical marijuana oil, but does not include the seeds, stalks, and roots of the plant. It does not include the weight of any nonmarijuana ingredients combined with marijuana, such as ingredients added to prepare a topical administration, food, or drink.

(22) “Verification system” means a phone or Web-based system that is available to law-enforcement personnel and compassion center agents on a 24-hour basis for verification of registry identification cards.

(23) “Written certification’’ means a document dated and signed by a health-care practitioner, stating that in the health-care practitioner’s professional opinion the patient is likely to receive therapeutic or palliative benefit from the medical use of marijuana to treat or alleviate the patient’s debilitating medical condition or symptoms associated with the debilitating medical condition. A written certification shall be made only in the course of a bona fide health-care practitioner-patient relationship where the qualifying patient is under the health-care practitioner’s care for the patient’s primary care or for the patient’s debilitating medical condition after the health-care practitioner has completed an assessment of the qualifying patient’s medical history and current medical condition. The bona fide health-care practitioner-patient relationship may not be limited to authorization for the patient to use medical marijuana or consultation for that purpose. The written certification must specify the qualifying patient’s debilitating medical condition.

(a) A registered qualifying patient shall not be subject to arrest, prosecution, or denial of any right or privilege, including but not limited to civil penalty or disciplinary action by a court or occupational or professional licensing board or bureau, for the medical use of marijuana pursuant to this chapter, if the registered qualifying patient does not possess more than 6 ounces of usable marijuana.

(b) A registered designated caregiver shall not be subject to arrest, prosecution, or denial of any right or privilege, including but not limited to civil penalty or disciplinary action by a court or occupational or professional licensing board or bureau:

(1) For assisting a registered qualifying patient to whom he or she is connected through the Department’s registration process with the medical use of marijuana if the designated caregiver does not possess more than 6 ounces of usable marijuana for each qualifying patient to whom he or she is connected through the Department’s registration process; and

(2) For receiving compensation for costs associated with assisting a registered qualifying patient’s medical use of marijuana if the registered designated caregiver is connected to the registered qualifying patient through the Department’s registration process.

(d) A registered qualifying patient or registered designated caregiver shall not be subject to prosecution, or denial of any right or privilege, including but not limited to civil penalty or disciplinary action by a court or occupational or professional licensing board or bureau for possession of seeds and stalks.

(e) A registered qualifying patient or registered designated caregiver shall not be subject to arrest, prosecution, or denial of any right or privilege, including but not limited to civil penalty or disciplinary action by a court or occupational or professional licensing board or bureau for giving marijuana to a registered qualifying patient, a registered compassion center, or a registered designated caregiver for a registered qualifying patient’s medical use where nothing of value is transferred in return, or for offering to do the same, if the person giving the marijuana does not knowingly cause the recipient to possess more marijuana than is permitted by this section.

(f) (1) There shall be a presumption that a qualifying patient is engaged in, or a designated caregiver is assisting with, the medical use of marijuana in accordance with this chapter if the qualifying patient or designated caregiver:

a. Is in possession of a valid registry identification card; and

b. Is in possession of an amount of marijuana that does not exceed the amount allowed under subsections (a), (b) and (c) [repealed] of this section.

(2) The presumption may be rebutted by evidence that conduct related to marijuana was not for the purpose of treating or alleviating the qualifying patient’s debilitating medical condition or symptoms associated with the debilitating medical condition in compliance with this chapter.

(g) A health-care practitioner may not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including a civil penalty or disciplinary action by the Delaware Medical Board or by any other occupational or professional licensing board or bureau, solely for providing written certifications or for otherwise stating that, in the health-care practitioner’s professional opinion, a patient is likely to receive therapeutic or palliative benefit from the medical use of marijuana to treat or alleviate the patient’s serious or debilitating medical condition or symptoms associated with the serious or debilitating medical condition or for refusing to provide such written certifications or statements, provided that nothing in this chapter is deemed to release a health-care practitioner from the duty to exercise a professional standard of care for evaluating or treating a patient’s medical condition.

(h) No person may be subject to arrest, prosecution, or denial of any right or privilege, including but not limited to civil penalty or disciplinary action by a court or occupational or professional licensing board or bureau, for:

(1) Selling marijuana paraphernalia to a cardholder upon presentation of an unexpired registry identification card in the recipient’s name or to a compassion center agent or safety compliance facility agent upon presentation of an unexpired copy of the entity’s registration certificate;

(2) Being in the presence or vicinity of the medical use of marijuana as allowed under this chapter; or

(3) Assisting a registered qualifying patient with using or administering marijuana.

(i) A registered compassion center shall not be subject to prosecution; search or inspection, except by the Department pursuant to § 4919A(u) of this title; seizure; or penalty in any manner, or be denied any right or privilege, including but not limited to civil penalty or disciplinary action by a court or business licensing board or entity, for:

(1) Acting pursuant to this chapter and Department regulations to acquire, possess, cultivate, manufacture, deliver, transfer, transport, supply, sell, or dispense marijuana or related supplies and educational materials to registered qualifying patients who have designated the compassion center to provide for them, to registered designated caregivers on behalf of the registered qualifying patients who have designated the registered compassion center, or to other registered compassion centers;

(2) Selling or transferring marijuana seeds to entities that are licensed or registered in another jurisdiction to dispense marijuana for medical purposes; or

(3) Transferring marijuana to and from a registered safety compliance facility for the purposes of analytical testing.

(j) A compassion center agent shall not be subject to prosecution, search, or penalty in any manner, or be denied any right or privilege, including but not limited to civil penalty or disciplinary action by a court or business licensing board or entity, for working or volunteering for a registered compassion center pursuant to this chapter and Department regulations to perform the actions on behalf of a registered compassion center that are authorized by this chapter.

(k) A Delaware facility which meets FDA-accepted security and operational standards shall not be subject to prosecution; search, except by the Department under § 4919A(u) of this title; seizure; or penalty in any manner, or be denied any right or privilege, including civil penalty or disciplinary action by a court or business licensing board or entity, solely for acting in accordance with this chapter, Department regulations, or federal law for the purposes of conducting research on marijuana under § 4928A of this title and pursuant to all applicable federal law on medical marijuana.

See also  Harlequin Cannabis Seeds

( l ) A registered safety compliance facility and safety compliance facility agents acting on behalf of a registered safety compliance facility shall not be subject to prosecution; search, except by the Department pursuant to § 4919A(u) of this title; seizure; or penalty in any manner, or be denied any right or privilege, including but not limited to civil penalty or disciplinary action by a court or business licensing board or entity, solely for acting in accordance with this chapter and Department regulations to provide the following services:

(1) Acquiring or possessing marijuana obtained from registered compassion centers;

(2) Returning the marijuana to the same registered compassion centers;

(3) Transporting marijuana that was produced by registered compassion centers to or from those registered compassion centers;

(4) Cultivating, manufacturing, and possessing marijuana for training and analytical testing;

(5) The production or sale of educational materials related to medical marijuana;

(6) The production, sale, or transportation of equipment or materials other than marijuana to registered compassion centers, including lab equipment and packaging materials, that are used by registered compassion centers;

(7) Testing of medical marijuana samples, including for potency and contamination;

(8) Providing training to prospective compassion center agents and compassion center agents, provided that only compassion center agents and safety compliance facility agents may be allowed to possess or cultivate marijuana and any possession or cultivation of marijuana must occur on the location registered with the Department; and

(9) Receiving compensation for actions allowed under this section.

(m) An entity that is registered to dispense marijuana for medical use in other jurisdictions shall not be subject to prosecution; search or inspection, except by the Department pursuant to § 4919A(u) of this title; seizure; or penalty in any manner or be denied any right or privilege, including but not limited to civil penalty or disciplinary action by a court or business licensing board or entity, for providing marijuana seeds to registered compassion centers.

(n) Any marijuana, marijuana paraphernalia, licit property, or interest in licit property that is possessed, owned, or used in connection with the medical use of marijuana as allowed under this chapter, or acts incidental to such use, shall not be seized or forfeited. This chapter shall not prevent the seizure or forfeiture of marijuana exceeding the amounts allowed under this chapter nor shall it prevent seizure or forfeiture if the basis for the action is unrelated to the marijuana that is possessed, manufactured, transferred, or used pursuant to this chapter.

(o) Mere possession of, or application for, a registry identification card or registration certificate shall not constitute probable cause or reasonable suspicion, nor shall it be used to support the search of the person, property, or home of the person possessing or applying for the registry identification card. The possession of, or application for, a registry identification card shall not preclude the existence of probable cause if probable cause exists on other grounds.

(p) For the purposes of Delaware state law, the medical use of marijuana by a cardholder or registered compassion center shall be considered lawful as long as it is in accordance with this chapter.

(q) Where a state-funded or locally funded law-enforcement agency encounters an individual who, during the course of the investigation, credibly asserts that he or she is a registered cardholder, or encounters an entity whose personnel credibly assert that it is a registered compassion center, the law-enforcement agency shall not provide any information from any marijuana-related investigation of the person to any law-enforcement authority that does not recognize the protection of this chapter and any prosecution of the individual, individuals, or entity for a violation of this chapter shall be conducted pursuant to the laws of this State.

(a) This chapter does not authorize any person to engage in, and does not prevent the imposition of any civil, criminal, or other penalties for engaging in, the following conduct:

(1) Undertaking any task under the influence of marijuana, when doing so would constitute negligence or professional malpractice;

(2) Except as provided in subsection (b) of this section, possessing marijuana, or otherwise engaging in the medical use of marijuana:

a. In a school bus;

b. On the grounds of any preschool or primary or secondary school; or

c. In any correctional facility.

d. In any health care or treatment facility operated by the Department or funded contractually through the Department.

(3) Smoking marijuana:

a. In any form of transportation; or

b. In any public place.

(4) Operating, navigating, or being in actual physical control of any motor vehicle, aircraft, or motorboat while under the influence of marijuana, except that a registered qualifying patient shall not be considered to be under the influence of marijuana solely because of the presence of metabolites or components of marijuana.

(5) Using marijuana if that person does not have a serious or debilitating medical condition.

(6) Transferring marijuana to any person who is not allowed to possess marijuana under this chapter.

(b) School exceptions. — Notwithstanding subsection (a) of this section, a designated caregiver registered pursuant to § 4908A of this title may possess for the purpose of administering, and may administer to a minor qualifying patient medical marijuana oil in a school bus and on the grounds or property of the preschool, or primary or secondary school in which a minor qualifying patient is enrolled. The designated caregiver shall not be a school nurse or other school employee hired or contracted by a school unless he or she is a parent or legal guardian of the minor qualifying patient, and said parent or legal guardian possesses no more than the number of doses prescribed per day of medical marijuana oil which is kept at all times on their person. Provided further, this exception shall only apply within the physical boundaries of the State of Delaware.

(a) (1) No school or landlord may refuse to enroll or lease to, or otherwise penalize, a person solely for his or her status as a registered qualifying patient or a registered designated caregiver, unless failing to do so would cause the school or landlord to lose a monetary or licensing-related benefit under federal law or regulations.

(2) For the purposes of medical care, including organ transplants, a registered qualifying patient’s authorized use of marijuana under this chapter is considered the equivalent of the authorized use of any other medication used at the direction of a health-care practitioner and does not constitute the use of an illicit substance or otherwise disqualify a qualifying patient from needed medical care.

(3) Unless a failure to do so would cause the employer to lose a monetary or licensing-related benefit under federal law or federal regulations, an employer may not discriminate against a person in hiring, termination, or any term or condition of employment, or otherwise penalize a person, if the discrimination is based upon either of the following:

a. The person’s status as a cardholder; or

b. A registered qualifying patient’s positive drug test for marijuana components or metabolites, unless the patient used, possessed, or was impaired by marijuana on the premises of the place of employment or during the hours of employment.

(b) A person otherwise entitled to custody of or visitation or parenting time with a minor shall not be denied such a right, and there shall be no presumption of neglect or child endangerment, for conduct allowed under this chapter, unless the person’s actions in relation to marijuana were such that they created an unreasonable danger to the safety of the minor as established by clear and convincing evidence.

(c) No school, landlord, or employer may be penalized or denied any benefit under state law for enrolling, leasing to, or employing a cardholder.

Once the regulations have been adopted pursuant to this chapter, any citizen may petition the Department to add conditions or treatments to the list of debilitating medical conditions listed in § 4902A(4) of this title. The Department shall consider petitions in the manner required by Department regulation, including public notice and hearing, as provided by § 4923A of this title. The Department shall approve or deny a petition within 180 days of its submission. The approval or denial of any petition is a final decision of the Department subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

(a) Nothing in this chapter requires any of the following:

(1) A government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana;

(2) Any person or establishment in lawful possession of property to allow a guest, client, customer, or other visitor to smoke marijuana on or in that property; or

(3) An employer to allow the ingestion of marijuana in any workplace or to allow any employee to work while under the influence of marijuana, except that a registered qualifying patient shall not be considered to be under the influence of marijuana solely because of the presence of metabolites or components of marijuana.

(4) A health-care practitioner to provide a written certification or otherwise recommend marijuana to a patient.

(b) Nothing in this chapter prohibits an employer from disciplining an employee for ingesting marijuana in the workplace or working while under the influence of marijuana.

(c) Nothing in this chapter shall be construed to prevent the arrest or prosecution of a registered qualifying patient for reckless driving or driving under the influence of marijuana where probable cause exists.

§ 4908A. Registration of qualifying patients and designated caregivers [For application of this section, see 82 Del. Laws, c. 246, § 5].

(a) The Department shall issue registry identification cards to qualifying patients who submit all of the following, in accordance with the Department’s final regulations:

(1) A written certification issued by a health-care practitioner within 90 days immediately preceding the date of an application.

(2) The application or renewal fee.

(3) The name, address, and date of birth of the qualifying patient, except that if the applicant is homeless no address is required.

(4) The name, address, and telephone number of the qualifying patient’s health-care practitioner.

(5) The name, address, and date of birth of the designated caregiver, if any, chosen by the qualifying patient.

(6) For a compassionate use card, the patient’s informed consent and health-care practitioner verification under subsection (c) of this section.

(7) A statement signed by the qualifying patient, pledging not to divert marijuana to anyone who is not allowed to possess marijuana pursuant to this chapter.

(8) A signed statement from the designated caregiver, if any, agreeing to be designated as the patient’s designated caregiver and pledging not to divert marijuana to anyone who is not allowed to possess marijuana pursuant to this chapter.

(b) Registry identification card applications shall be available no later than the day the Department publishes final regulations.

(c) The Department shall issue a compassionate use card to an individual who is eligible for a compassionate use card and who submits all of the following, in accordance with the Department’s final regulations, in addition to the requirements under subsection (a) of this section:

(1) A signed statement from the patient’s health-care practitioner that includes statements attesting to all of the following:

a. The patient has a severe and debilitating condition.

b. All current standard care practices and treatments have been exhausted and have been ineffective or the side effects are prohibitive with continued use.

c. The health-care practitioner will re-evaluate and document the efficacy of medical marijuana treatment.

d. There are grounds supporting the potential for the patient to benefit from using medical marijuana.

(2) a. If the patient is an adult, a signed statement from the patient acknowledging the patient’s informed consent to treatment with medical marijuana and that the patient knows that there is limited or no evidence associated with medical marijuana’s effectiveness in treating a condition that is not a debilitating medical condition under this chapter.

b. If the patient is under 18 years of age, a signed statement from the patient’s parent or legal guardian acknowledging the patient’s informed consent to treatment with medical marijuana and that the patient’s parent or legal guardian knows that there is limited or no evidence associated with medical marijuana’s effectiveness in treating a condition that is not a debilitating medical condition under this chapter.

(d) (1) An adult is eligible for a CBD-rich card if the individual complies with subsection (a) of this section and the written certification from the patient’s health-care practitioner recommends medical marijuana for the treatment of anxiety or other condition approved by the Department for treatment with cannabidiol-rich medical marijuana.

(2) A patient who qualifies for a CBD-rich card may only receive cannabidiol-rich medical marijuana products.

§ 4909A. Issuance of registry identification cards [For application of this section, see 82 Del. Laws, c. 213, § 7].

(a) Except as provided in subsection (b) of this section, the Department shall:

(1) Verify the information contained in an application or renewal submitted pursuant to this chapter, and shall approve or deny an application or renewal within 45 days of receiving a completed application or renewal application.

(2) Issue registry identification cards to a qualifying patient and his or her designated caregiver, if any, within 30 days of approving the application or renewal. A designated caregiver must have a registry identification card for each of his or her qualifying patients.

(3) Enter the registry identification number of the registered compassion center the patient designates into the verification system.

(b) The Department may not issue a registry identification card to a qualifying patient who is under 18 years of age, except if any of the following apply:

(1) The qualifying patient has any of the following related to a terminal illness:

(2) The qualifying patient has intractable epilepsy or seizure disorder.

(3) The qualifying patient has a chronic or debilitating disease or medical condition where the patient has failed treatment involving 1 or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; severe, painful and persistent muscle spasms; chronic debilitating migraines and new daily persistent headache that are refractory to conventional treatment and interventions.

(4) Any other medical condition or its treatment added by the Department, as provided for in § 4906A of this title.

(5) The qualifying patient is eligible for a compassionate use card under § 4908A(c) of this title.

(c) A qualifying patient who is under 18 years of age may only receive marijuana oil.

§ 4910A. Denial of registry identification cards [For application of this section, see 82 Del. Laws, c. 213, § 7].

(a) The Department shall deny an application or renewal of a qualifying patient’s registry identification card only if the applicant:

(1) Did not provide the required information and materials;

(2) Previously had a registry identification card revoked; or

(3) Provided false or falsified information.

(b) The Department shall deny an application or renewal for a designated caregiver chosen by a qualifying patient whose registry identification card was granted only if:

(1) The designated caregiver does not meet the requirements of § 4902A(6) of this title;

(2) The applicant did not provide the information required;

(3) The designated caregiver previously had a registry identification card revoked; or

(4) The applicant or the designated caregiver provides false or falsified information.

(c) A prospective designated caregiver shall obtain a background check in compliance with § 4927A of this title to enable the Department to comply with subsection (b) of this section. Once a prospective designated caregiver has been granted a registry identification card, the designated caregiver must obtain a background check in compliance with § 4927A of this title every 3 years.

(d) The Department shall notify the qualifying patient who has designated someone to serve as his or her designated caregiver if a registry identification card will not be issued to the designated caregiver.

(e) (1) Denial of an application or renewal is considered a final Department action.

(2) A denial of an application or renewal for a registry identification card for a registered qualifying patient, pediatric patient, or registered designated caregiver is subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

(3) A denial of an application or renewal for a compassionate use registry identification card is not subject to judicial review.

§ 4911A. Registry identification cards [For application of this section, see 82 Del. Laws, c. 246, § 5].

(a) Registry identification cards must contain all of the following:

(1) The name of the cardholder.

(2) A designation of whether the cardholder is a designated caregiver or qualifying patient.

(3) That the registered cardholder is 1 of the following:

a. A qualifying adult patient.

b. A designated caregiver for a qualifying adult patient.

c. A designated caregiver for a pediatric patient.

d. An adult compassionate use patient.

e. A designated caregiver for an adult compassionate use patient.

f. A designated caregiver for a pediatric compassionate use patient.

g. A CBD-rich patient.

h. A designated caregiver for a CBD-rich patient.

(4) The date of issuance and expiration date of the registry identification card.

(5) A random 10-digit alphanumeric identification number, that is unique to the cardholder.

(6) If the cardholder is a designated caregiver, the random 10-digit alphanumeric identification number of the qualifying patient the designated caregiver is receiving the registry identification card to assist.

(b) (1) Except as provided in this subsection, the expiration date of a registry identification card is 1 year after the date of issuance.

(2) If the health-care practitioner stated in the written certification that the qualifying patient would benefit from marijuana until a specified earlier date, then the registry identification card expires on that date.

(3) If the health-care practitioner stated in the written certification that the compassionate use patient would benefit from a trial period using marijuana until a specified earlier date, then the registry identification card expires on that date.

(c) The Department may, at its discretion, electronically store in the card all of the information listed in subsection (a) of this section, along with the address and date of birth of the cardholder, to allow it to be read by law-enforcement agents.

(a) The following notifications and Department responses are required:

(1) A registered qualifying patient shall notify the Department of any change in his or her name or address, or if the registered qualifying patient ceases to have his or her debilitating medical condition, within 10 days of the change.

(2) A registered designated caregiver shall notify the Department of any change in his or her name or address, or if the designated caregiver becomes aware the qualifying patient passed away, within 10 days of the change.

(3) Before a registered qualifying patient changes his or her designated caregiver, the qualifying patient must notify the Department.

(4) If a cardholder loses his or her registry identification card, he or she shall notify the Department within 10 days of becoming aware the card has been lost.

(b) When a cardholder notifies the Department of items listed in subsection (a) of this section, but remains eligible under this chapter, the Department shall issue the cardholder a new registry identification card with a new random 10-digit alphanumeric identification number within 10 days of receiving the updated information and pay a $20 fee. If the person notifying the Department is a registered qualifying patient, the Department shall also issue his or her registered designated caregiver, if any, a new registry identification card within 10 days of receiving the updated information.

(c) If a registered qualifying patient ceases to be a registered qualifying patient or changes his or her registered designated caregiver, the Department shall promptly notify the designated caregiver. The registered designated caregiver’s protections under this chapter as to that qualifying patient shall expire 15 days after notification by the Department.

(d) A cardholder who fails to make a notification to the Department that is required by this section is subject to a civil infraction, punishable by a penalty of no more than $150.

(e) The Department shall administer a real-time statewide patient registry to facilitate patient choice in purchasing medical marijuana from any properly licensed Delaware Compassion Centers. The registry shall track patient purchases to comply with § 4919A(i) of this title.

(f) If the registered qualifying patient’s certifying health-care practitioner notifies the Department in writing that either the registered qualifying patient has ceased to suffer from a debilitating medical condition or that the health-care practitioner no longer believes the patient would receive therapeutic or palliative benefit from the medical use of marijuana, the card becomes null and void. However, the registered qualifying patient has 15 days to dispose of their marijuana or give it to a registered compassion center where nothing of value is transferred in return.

(a) Except as provided in § 4904A of this title and this section, an individual may assert a medical purpose for using marijuana as a defense to any prosecution of an offense involving marijuana intended for the patient’s medical use, and this defense shall be presumed valid and the prosecution shall be dismissed where the evidence shows all of the following:

(1) A health-care practitioner states that, in the health-care practitioner’s professional opinion, after having completed a full assessment of the individual’s medical history and current medical condition made in the course of a bona fide health-care practitioner-patient relationship, the patient is likely to receive therapeutic or palliative benefit from marijuana to treat or alleviate the individual’s serious or debilitating medical condition or symptoms associated with the individual’s serious or debilitating medical condition.

(2) The individual was in possession of no more than 6 ounces of usable marijuana.

(3) The individual was engaged in the acquisition, possession, use, or transportation of marijuana, paraphernalia, or both, relating to the administration of marijuana to treat or alleviate the individual’s serious or debilitating medical condition or symptoms associated with the individual’s serious or debilitating medical condition.

(b) The defense and motion to dismiss shall not prevail if the prosecution proves that

(1) The individual had a registry identification card revoked for misconduct; or

(2) The purposes for the possession of marijuana were not solely for palliative or therapeutic use by the individual with a serious or debilitating medical condition who raised the defense.

(c) An individual is not required to possess a registry identification card to raise the affirmative defense set forth in this section.

(d) If an individual demonstrates the individual’s medical purpose for using marijuana pursuant to this section, except as provided in § 4909A of this title, the individual shall not be subject to the following for the individual’s use of marijuana for medical purposes:

(1) Disciplinary action by an occupational or professional licensing board or bureau; or

(2) Forfeiture of any interest in or right to nonmarijuana, licit property.

(e) (1) This section shall only apply for arrests made after July 1, 2011, until 75 days after registration for qualified patients is available, and

(2) Thereafter, for arrests made after a valid an application for a qualifying patient has been submitted and before the registry identification card has been received.

(a) Compassion centers may only operate if they have been issued a valid registration certificate from the Department. When applying for a compassion center registration certificate, the applicant shall submit the following in accordance with Department regulations:

(1) An application fee in an amount determined by the Department’s regulations.

(2) The proposed legal name of the compassion center.

(3) The proposed physical address of the compassion center and the proposed physical address of any additional locations, if any, where marijuana will be cultivated, harvested, packaged, labeled, or otherwise prepared for distribution by the compassion center.

(4) The name, address, and date of birth of each principal officer and board member of the compassion center, provided that all such individuals shall be at least 21 years of age.

(5) Any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding.

(6) Proposed operating bylaws that include procedures for the oversight of the compassion center and procedures to ensure accurate record keeping and security measures that are in accordance with the regulations issued by the Department pursuant to this chapter. The by-laws shall include a description of the enclosed, locked facility where medical marijuana will be grown, cultivated, harvested, packaged, labeled, or otherwise prepared for distribution by the compassion center.

(7) Any information required by the Department to evaluate the applicant pursuant to the competitive bidding process described in subsection (b) of this section.

(b) The Department shall evaluate applications for compassion center registration certificates using an impartial and numerically scored competitive bidding process developed by the Department in accordance with this chapter. The registration considerations shall consist of the following criteria:

(1) Documentation of not-for-profit status, consistent with § 4919A(a) of this title.

(2) The suitability of the proposed location or locations, including but not limited to compliance with any local zoning laws and the geographic convenience to patients from throughout the State of Delaware to compassion centers if the applicant were approved.

(3) The principal officer and board members’ character and relevant experience, including any training or professional licensing related to medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation and preparation and their experience running businesses or not-for-profits.

(4) The proposed compassion center’s plan for operations and services, including its staffing and training plans, whether it has sufficient capital to operate, and its ability to provide an adequate supply of medical marijuana to the registered patients in the State.

(5) The sufficiency of the applicant’s plans for record keeping.

(6) The sufficiency of the applicant’s plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed.

(7) The applicant’s plan for making medical marijuana available on an affordable basis to registered qualifying patients enrolled in Medicaid or receiving Supplemental Security Income or Social Security Disability Insurance.

(8) The applicant’s plan for safe and accurate packaging and labeling of medical marijuana, including the applicant’s plan for ensuring that all medical marijuana is free of contaminants.

(c) No later than July 1, 2012, the Department shall issue a request for applications for compassion center registration certificates. The Department shall issue a compassion center registration certificate to the highest scoring applicant in each county by January 1, 2013. If there are only applicants from 1 or 2 counties, no later than January 1, 2013, the Department shall issue a compassion center registration certificate to the highest scoring applicant in each county with an applicant. If the revenue received from the fees generated by this chapter and donations covers the cost of implementing the program established by this chapter, certificates will be awarded.

(d) By January 1, 2014, the Department shall issue additional registration certifications to at least 3 of the highest scoring applicants not already awarded a registration certificate, provided a sufficient number of qualified additional applicants have applied. If the Department determines, after reviewing the report issued pursuant to § 4922A of this title, that additional compassion centers are needed to meet the needs of registered qualifying patients throughout the State, the Department shall issue registration certificates to the corresponding number of applicants who score the highest.

(e) (1) At any time after July 1, 2013, that the number of outstanding and valid registered compassion center certificates is lower than the number of registration certificates the Department is required to issue pursuant to subsection (d) of this section, the Department shall accept applications for compassion centers and issue registration certificates to the corresponding number of additional applicants who score the highest while ensuring at least 1 compassion center is registered in each county.

(2) Notwithstanding subsections (c), (d), and paragraph (e)(1) of this section, an application for a compassion center registration certificate must be denied if any of the following conditions are met:

a. The applicant failed to submit the materials required by this section, including if the applicant’s plans do not satisfy the security, oversight, or recordkeeping regulations issued by the Department;

b. The applicant would not be in compliance with local zoning regulations issued in accordance with § 4917A of this title;

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c. The applicant does not meet the requirements of § 4919A of this title;

d. One or more of the prospective principal officers or board members has been convicted of an excluded felony offense or has been convicted of a misdemeanor drug offense, as provided in Title 16 or an equivalent offense from another jurisdiction, within 5 years from the date of application that is not excluded by § 4902A(8)b.2. of this title; and

e. One or more of the prospective principal officers or board members has served as a principal officer or board member for a registered compassion center that has had its registration certificate revoked; and

f. One or more of the principal officers or board members is younger than 21 years of age.

(f) Before a compassion center is approved, it shall submit a registration fee to the Department in the amount determined by the Department’s regulations and, if a physical address had not been finalized when it applied, it shall submit a complete listing of all its physical addresses.

(g) When issuing a compassion center registration certificate, the Department shall also issue a renewable registration certificate with an identification number.

(a) Safety compliance facilities may only operate if they have been issued a valid registration certificate from the Department. When applying for a safety compliance facility registration certificate, the applicant shall submit the following in accordance with Department regulations:

(1) A nonrefundable application fee in an amount determined by the Department’s regulations;

(2) The proposed legal name of the safety compliance facility;

(3) The proposed physical address of the safety compliance facility;

(4) The name, address, and date of birth of each principal officer and board member of the safety compliance facility, provided that all such individuals shall be at least 21 years of age;

(5) Any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding; and

(6) Any information required by the Department to evaluate the applicant pursuant to the competitive bidding process described in subsection (b) of this section.

(b) The Department shall evaluate applications for safety compliance facility registration certificates using an impartial and numerically scored competitive bidding process developed by the Department in accordance with this chapter. The registration considerations shall consist of the following criteria:

(1) The proposed principal officers’ and board members’ relevant experience, including any training or professional licensing related to analytical testing, medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation, preparation, and testing and their experience running businesses or not-for-profits;

(2) The suitability of the proposed location, including compliance with any local zoning laws and the geographic convenience to compassion centers from throughout the State of Delaware to registered safety compliance facilities if the applicant were approved;

(3) The sufficiency of the applicant’s plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed; and

(4) The proposed safety compliance facility’s plan for operations and services, including its staffing and training plans, and whether it has sufficient capital to operate.

(c) The Department shall issue at least 1 safety compliance facility registration certificate to the highest scoring applicant by January 1, 2013, if the revenue received from the fees generated by this chapter and donations covers the cost of implementing the program established by this chapter.

(d) (1) The Department may issue additional safety compliance facility registration certificates to the highest scoring applicant or applicants. If the Department determines, after reviewing the report issued pursuant to § 4922A of this title, that additional safety compliance facilities are needed to meet the needs of cardholders and registered compassion centers throughout the State, the Department shall issue registration certificates to the corresponding number of applicants who score the highest.

(2) Notwithstanding subsection (c) and paragraph (d)(1) of this section, an application for a safety compliance facility registration certificate must be denied if any of the following conditions are met:

a. The applicant failed to submit the materials required by this section, including if the plans do not satisfy the security, oversight, or recordkeeping regulations issued by the Department;

b. The applicant would not be in compliance with local zoning regulations issued in accordance with § 4917A of this title;

c. The applicant does not meet the requirements of § 4919A of this title;

d. One or more of the prospective principal officers or board members has been convicted of an excluded felony offense or has been convicted of a misdemeanor drug offense, as provided in Title 16 or an equivalent offense from another jurisdiction, within 5 years from the date of application that is not excluded by § 4902A(8)b.2. of this title;

e. One or more of the prospective principal officers or board members has served as a principal officer or board member for a registered safety compliance facility or registered compassion center that has had its registration certificate revoked; and

f. One or more of the principal officers or board members is younger than 21 years of age.

(e) Before a safety compliance facility is approved, it shall submit a registration fee paid to the Department in the amount determined by Department regulation and, if a physical address had not been finalized when it applied, its physical address.

(f) When issuing a safety compliance facility registration certificate, the Department shall also issue a renewable registration certificate with an identification number. The Department shall also provide the registered safety compliance facility with the contact information for the verification system.

Registration certificates may be renewed every 2 years. The registered compassion center or registered safety compliance facility may submit a renewal application beginning 90 days prior to the expiration of its registration certificate. The Department shall grant a renewal application within 30 days of its submission if the following conditions are all satisfied:

(1) The registered compassion center or registered safety compliance facility submits a renewal application and the required renewal fee, which shall be refunded within 30 days if the renewal application is rejected;

(2) The Department has not suspended the registered compassion center or registered safety compliance facility’s registration certificate for violations of this chapter or regulations adopted pursuant to this chapter; and

(3) The inspections authorized by § 4919A(u) of this title and the annual report, provided pursuant to § 4922A of this title, do not raise serious concerns about the continued operation of the registered compassion center or registered safety compliance facility applying for renewal.

(4) The applicant still complies with the qualifications required in §§ 4914A and 4915A of this title.

Nothing shall prohibit local governments from enacting ordinances or regulations not in conflict with this chapter or with Department regulations regulating the time, place, and manner of registered compassion center operations and registered safety compliance facilities, provided that no local government may prohibit registered compassion center operation altogether, either expressly or though the enactment of ordinances or regulations which make registered compassion center and registered safety compliance facility operation unreasonably impracticable in the jurisdiction.

(a) (1) Every person seeking to become a principal officer, board member, agent, volunteer, or employee of a registered compassion center or a registered safety compliance facility shall obtain a background check in compliance with § 4927A of this title before beginning work, with or without compensation, at a registered compassion center or a registered safety compliance facility. Once a person becomes a principal officer, board member, agent, volunteer, or employee of a registered compassion center or a registered safety compliance facility, the person must obtain a background check in compliance with § 4927A of this title every 5 years.

(2) A registered compassion center or a registered safety compliance facility may not employ, with or without compensation, any person who:

a. Was convicted of an excluded felony offense;

b. Is under 21 years of age;

c. Has been convicted of a misdemeanor drug offense, as provided in this title or an equivalent offense from another jurisdiction, within 5 years from the date of the application that is not excluded in § 4902A(8)b.2. of this title.

(3) The Department is responsible for reviewing the background check of a person seeking to become, or who is, a principal officer, board member, agent, volunteer, or employee of a registered compassion center or a registered safety compliance facility to determine if the person complies with paragraph (a)(2) of this section. The Department shall notify the registered compassion center or registered safety compliance facility if a person is disqualified under paragraph (a)(2) of this section.

(b) A registered compassion center or safety compliance facility agent must have documentation when transporting marijuana on behalf of the registered safety compliance facility or registered compassion center that specifies the amount of marijuana being transported, the date the marijuana is being transported, the registry ID certificate number of the registered compassion center or registered safety compliance facility, and a contact number to verify that the marijuana is being transported on behalf of the registered compassion center or registered safety compliance facility.

(a) A registered compassion center shall be operated on a not-for-profit basis. The bylaws of a registered compassion center shall contain such provisions relative to the disposition of revenues to establish and maintain its not-for-profit character. A registered compassion center need not be recognized as tax-exempt by the Internal Revenue Service and is not required to incorporate pursuant to Title 8.

(b) The operating documents of a registered compassion center shall include procedures for the oversight of the registered compassion center and procedures to ensure accurate recordkeeping.

(c) A registered compassion center and a registered safety compliance facility shall implement appropriate security measures to deter and prevent the theft of marijuana and unauthorized entrance into areas containing marijuana.

(d) A registered compassion center and a registered safety compliance facility may not be located within 500 feet of the property line of a preexisting public or private school.

(e) A registered compassion center is prohibited from acquiring, possessing, cultivating, manufacturing, delivering, transferring, transporting, supplying, or dispensing marijuana for any purpose except to assist registered qualifying patients with the medical use of marijuana directly or through the qualifying patients’ designated caregivers.

(f) All cultivation of marijuana for registered compassion centers must take place in an enclosed, locked location at the physical address or addresses provided to the Department during the registration process, which can only be accessed by compassion center agents working or volunteering for the registered compassion center.

(g) A registered compassion center may not purchase usable marijuana or mature marijuana plants from any person other than another registered compassion center.

(h) Before marijuana may be dispensed to a designated caregiver or a registered qualifying patient, a compassion center agent must determine that the individual is a current cardholder in the verification system and must verify each of the following:

(1) That the registry identification card presented to the registered compassion center is valid;

(2) That the person presenting the card is the person identified on the registry identification card presented to the compassion center agent; and

(3) That the registered compassion center is the designated compassion center for the registered qualifying patient who is obtaining the marijuana directly or via his or her designated caregiver.

(i) A registered compassion center shall not dispense more than 3 ounces of marijuana to a registered qualifying patient, directly or via a designated caregiver, in any 14-day period. Registered compassion centers shall ensure compliance with this limitation by maintaining internal, confidential records that include records specifying how much marijuana is being dispensed to the registered qualifying patient and whether it was dispensed directly to the registered qualifying patient or to the designated caregiver. Each entry must include the date and time the marijuana was dispensed. These records must be maintained by the compassion centers for a minimum of 3 years.

(k) No person may advertise medical marijuana sales in print, broadcast, or by paid in-person solicitation of customers. This shall not prevent appropriate signs on the property of the registered compassion center, listings in business directories including phone books, listings in trade or medical publications, or the sponsorship of health or not-for-profit charity or advocacy events.

( l ) A registered compassion center may not share office space with nor refer patients to a health-care practitioner.

(m) A health-care practitioner may not refer patients to a registered compassion center or registered designated caregiver, advertise in a registered compassion center, or, if the health-care practitioner issues written certifications, hold any financial interest in a registered compassion center.

(n) No person who has been convicted of an excluded felony offense or has been convicted of a misdemeanor drug offense, as provided in this title or an equivalent offense from another jurisdiction, within 5 years from the date of application that is not excluded by § 4902A(8)b.2. of this title may be a compassion center agent.

(o) The Department shall issue a civil fine of up to $3,000 for violations of this section.

(p) The Department shall suspend or revoke a registration certificate for serious or multiple violations of this chapter and regulations issued in accordance with this chapter. A registered compassion center may continue to cultivate and possess marijuana plants during a suspension, but it may not dispense, transfer, or sell marijuana.

(q) The suspension or revocation of a certificate is a final Department action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

(r) Any cardholder who sells marijuana to a person who is not allowed to possess marijuana for medical purposes under this chapter shall have his or her registry identification card revoked and shall be subject to other penalties for the unauthorized sale of marijuana.

(s) Any registered qualifying patient, registered designated caregiver, compassion center agent, or safety compliance facility agent, including a principal owner, board member, employee or volunteer who has access to compassion center or safety compliance facility records, who sells marijuana to someone who is not allowed to use marijuana for medical purposes or who fails to maintain, fraudulently maintains, or fraudulently represents to the Department records required by this chapter or rules promulgated pursuant to this chapter, for the purposes of selling marijuana to someone who is not allowed to use marijuana for medical purposes under this chapter is guilty of a felony punishable by imprisonment for not more than 2 years or a fine of not more than $2,000, or both, in addition to any other penalties for the distribution of marijuana.

(t) The Department shall revoke the registry identification card of any cardholder who knowingly commits multiple or serious violations of this chapter.

(u) Registered compassion centers are subject to random and reasonable inspection by the Department. The Department shall give reasonable notice of an inspection under this paragraph.

(v) Fraudulent representation to a law-enforcement official of any fact or circumstance relating to the medical use of marijuana to avoid arrest or prosecution shall be a class B misdemeanor which may be punishable by up to 6 months incarceration at Level V under § 4204 of Title 11 and a fine of up to $1,150, as the Court deems appropriate which shall be in addition to any other penalties that may apply for making a false statement or for the use of marijuana other than use undertaken pursuant to this chapter and jurisdiction for prosecution shall be exclusively in Superior Court.

(w) Registration cards issued pursuant to § 4909A of this title shall be in the possession of the registrant while in possession of medical marijuana outside the registrant’s residence and may be subject to prosecution for failure to do so. If the registrant is unable to produce a valid § 4909A of this title registration card within 2 weeks of the summons, the penalty for a violation of this section shall be an unclassified misdemeanor and jurisdiction shall be exclusively in Superior Court.

(x) For registered qualifying patients and designated caregivers, medical marijuana shall be contained, when not being prepared for ingestion or ingested and outside the registrant’s residence, within, sealed, tamperproof containers issued by compassion centers pursuant to Department regulations and may be subject to prosecution for failure to do so. If the registrant is unable to produce a sealed, tamperproof container within 2 weeks of the summons, the penalty for a violation of this section shall be an unclassified misdemeanor.

(a) The following information received and records kept by the Department for purposes of administering this chapter are confidential and exempt from the Delaware Freedom of Information Act [Chapter 100 of Title 29], and not subject to disclosure to any individual or public or private entity, except as necessary for authorized employees of the State of Delaware to perform official duties pursuant to this chapter:

(1) Applications and renewals, their contents, and supporting information submitted by qualifying patients and designated caregivers, including information regarding their designated caregivers and health-care practitioners.

(2) Applications and renewals, their contents, and supporting information submitted by or on behalf of compassion centers and safety compliance facilities in compliance with this chapter, including their physical addressees.

(3) The individual names and other information identifying persons to whom the Department has issued registry identification cards.

(4) Any dispensing information required to be kept under § 4919A of this title or Department regulation shall identify cardholders and registered compassion centers by their registry identification numbers and not contain names or other personally identifying information.

(5) Any Department hard drives or other data-recording media that are no longer in use and that contain cardholder information must be destroyed. The Department shall retain a signed statement from a Department employee confirming the destruction.

(b) Nothing in this section precludes the following:

(1) Department employees shall notify law-enforcement about falsified or fraudulent information submitted to the Department if the employee who suspects that falsified or fraudulent information has been submitted.

(2) The Department shall notify state or local law-enforcement about apparent criminal violations of this chapter.

(3) Compassion center agents shall notify the Department of a suspected violation or attempted violation of this chapter or the regulations issued pursuant to it.

(4) The Department shall verify registry identification cards pursuant to 4921A of this title.

(5) The submission of the § 4922A of this title report to the legislature.

Information obtained pursuant to this chapter is subject to the same protections and penalties afforded other health information under the Health Insurance Portability and Accountability Act (HIPAA), 45 C.F.R. Part 160, 162 and 164.

(a) The Department shall maintain a confidential list of the persons to whom the Department has issued registry identification cards and their addresses, phone numbers, and registry identification numbers.

(b) The Department shall maintain a verification system which shall be established by January 1, 2013. The verification system must allow law-enforcement personnel, compassion center agents, and safety compliance facility agents to enter a registry identification number to determine whether or not the number corresponds with a current, valid registry identification card. The system shall only disclose whether the identification card is valid; whether the cardholder is a registered qualifying patient or a registered designated caregiver; the registry identification number of the registered compassion center designated to serve the registered qualifying patient; and, if the cardholder is a registered designated caregiver, the registry identification number of the registered qualified patient who is assisted by the cardholder.

(c) The Department shall, with a cardholder’s permission, confirm his or her status as a registered qualifying patient or registered designated caregiver to a landlord, employer, school, medical professional, or court.

(d) The Department shall disclose the names of any person whose registry identification card was revoked to any court where the person is seeking to assert the protections of 4913A of this title.

(a) The Medical Marijuana Act Oversight Committee is established to evaluate and make recommendations regarding the implementation of this chapter.

(1) The Oversight Committee shall consist of 9 members who possess the qualifications and are appointed as follows:

a. One member, appointed by the President Pro Tempore of the Senate.

b. One member, appointed by the Speaker of the House.

c. The Secretary of the Department, or a designee appointed by the Secretary.

d. Two medical professionals, each licensed in Delaware, with experience in medical marijuana issues, appointed by the Governor.

e. One member with experience in policy development or implementation in the field of medical marijuana, appointed by the Governor.

f. Three members who each shall be a cardholder, as defined in § 4902A of this title, appointed by the Governor.

(2) The members of the Oversight Committee shall serve at the pleasure of the appointing authority.

(3) A quorum shall consist of 51% of the membership of the Oversight Committee.

(4) The Oversight Committee shall select a Chair and Vice Chair from among its members.

(5) Staff support for the Oversight Committee shall be provided by the Department.

(6) The Oversight Committee shall meet at least 2 times per year for the purpose of evaluating and making recommendations to the Governor, the General Assembly, and the Department regarding the following:

a. The ability of qualifying patients in all areas of the State to obtain timely access to high-quality medical marijuana.

b. The effectiveness of the registered compassion centers, individually and together, in serving the needs of qualifying patients, including the provision of educational and support services, the reasonableness of their fees, whether they are generating any complaints or security problems, and the sufficiency of the number operating to serve the registered qualifying patients of Delaware.

c. The effectiveness of the registered safety compliance facility or facilities, including whether a sufficient number are operating.

d. The sufficiency of the regulatory and security safeguards contained in this chapter and adopted by the Department to ensure that access to and use of marijuana cultivated is provided only to cardholders authorized for such purposes.

e. Any recommended additions or revisions to the Department regulations or this chapter, including relating to security, safe handling, labeling, and nomenclature.

f. Any research studies regarding health effects of medical marijuana for patients.

(b) The Department shall submit to the Governor and the General Assembly an annual report that does not disclose any identifying information about cardholders, registered compassion centers, or health-care practitioners, but does contain, at a minimum, all of the following information:

(1) The number of applications and renewals filed for registry identification cards.

(2) The number of qualifying patients and designated caregivers approved in each county.

(3) The nature of the debilitating medical conditions of the qualifying patients.

(4) The number of registry identification cards revoked for misconduct.

(5) The number of health-care practitioners providing written certifications for qualifying patients.

(6) The number of registered compassion centers.

(7) Specific accounting of fees and costs.

§ 4923A. Department to issue regulations [For application of this section, see 82 Del. Laws, c. 246, § 5].

The Department shall promulgate regulations regarding all of the following:

(1) Governing the manner in which the Department shall consider petitions from the public to add debilitating medical conditions or treatments to the list of debilitating medical conditions under § 4902A(4) of this title, including public notice of and an opportunity to comment in public hearings on the petitions.

(2) a. Establishing the form and content of registration and renewal applications submitted under this chapter.

b. For compassionate use cards, governing the intervals at which a health-care practitioner must re-evaluate the efficacy of medical marijuana treatment and the documentation of the re-evaluations, and may include intervals of different lengths for the conditions for which a patient receives a compassionate use registry identification card.

(3) Governing the manner in which it shall consider applications for and renewals of registry identification cards.

(4) Governing all of the following matters related to registered compassion centers and security compliance facilities, with the goal of protecting against diversion and theft, without imposing an undue burden on the registered compassion centers or compromising the confidentiality of cardholders:

a. Minimum oversight requirements for registered compassion centers.

b. Minimum recordkeeping requirements for registered compassion centers.

c. Minimum security requirements for registered compassion centers, which shall include that each registered compassion center location must be protected by a fully operational security alarm system.

d. The competitive scoring process addressed in §§ 4914A and 4915A of this title.

e. Procedures for suspending or terminating the registration certificates or registry identification cards of cardholders, registered compassion centers, and registered safety compliance facilities that commit multiple or serious violations of the provisions of this chapter or the regulations promulgated pursuant to this section.

f. The design and security features of medical marijuana containers to be provided by the compassion centers.

(5) Requiring application and renewal fees for registry identification cards, and registered compassion center registration certificates, according to all of the following:

a. The total fees collected must generate revenues sufficient to offset all expenses of implementing and administering this chapter, except that fee revenue may be offset or supplemented by private donations.

b. The total amount of revenue from application, renewal, and registration fees for compassion centers and security compliance facilities must be sufficient to implement and administer the compassion center and safety compliance facility provisions of this chapter.

c. The Department may establish a sliding scale of patient application and renewal fees based upon a qualifying patient’s household income.

d. The Department may accept donations from private sources to reduce application and renewal fees.

e. The total amount of revenue from application, renewal, and registration fees for compassion centers, security compliance facilities, and registry identification cards will be deposited to a special account within the Department for the operation of the program created by this chapter and shall be used as necessary to support program operations and growth.

(6) Establishing requirements for cannabidiol-rich medical marijuana profile concentrations.

If the Department fails to adopt regulations to implement this chapter within the times provided for in this chapter, any citizen may commence an action in Superior Court to compel the Department to perform the actions mandated pursuant to the provisions of this chapter.

Any section of this chapter being held invalid as to any person or circumstance shall not affect the application of any other section of this chapter that can be given full effect without the invalid section or application.

This chapter shall take effect on the first day of the fiscal year following its enactment into law. If, however, the chapter, is not enacted before July 1, 2011, then the effective date shall be 90 days from enactment. [The chapter became effective on July 1, 2011.]

(a) A person required to obtain a background check under this chapter shall submit fingerprints and other necessary information to the State Bureau of Identification in order to obtain all of the following:

(1) A report of the person’s entire criminal history record from the State Bureau of Identification or a statement that the State Bureau of Identification Central Repository contains no such information relating to that person.

(2) A report of the person’s entire federal criminal history record from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C. § 534) or a statement that the Federal Bureau of Investigation’s records contain no such information relating to that person.

(b) The State Bureau of Identification shall be the intermediary for the purpose of subsection (a) of this section and shall forward all information required by subsection (a) of this section to the Department.

(c) The Department shall use the background check required by this section only to determine if the person required to obtain a background check meets the requirements of this chapter.

(d) A person required to obtain a background check under this chapter is responsible for any costs associated with obtaining the background check.

(a) Research for the development of well-characterized and more-defined medical marijuana products for treatment of target indications, including demonstrations of safety and efficacy for treatment of medical conditions that often fail to respond to conventional treatment, may be conducted in Delaware.

(b) Research performed under the authority of this chapter shall be conducted as follows:

(1) In a facility which meets FDA-accepted security and operational standards.

(2) Using practices and standards that ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of data, including good laboratory standards (GLP) when required.