When was marinol approved by fda

The proposed rule was based on the DHHS scientific and medical evaluation and scheduling recommendation and DEA's independent evaluation. Also under the proposed rule, 21 CFR As discussed above, this proposed amendment to 21 CFR The notice of proposed rule provided an opportunity for all interested persons to submit their comments, objections, or requests for hearing in writing to DEA on or before December 7, DEA received comments regarding the proposed rule from ten persons.

Nine of the commenters supported the proposed rule. One commenter objected to the proposed rule and requested a hearing thereon. The comments are briefly summarized below. The nine commenters who supported the proposed rule included organizations, physicians, and one individual.

Eight of the nine commenters who supported the proposed rule expressed the opinion that Marinol is a safe and effective alternative to smoking marijuana for treatment of nausea and loss of appetite and has low abuse potential. One commenter who supported the proposed rule expressed the view that the rescheduling of Marinol should not serve as a substitute for making marijuana legally available for medical use. This commenter stated that it supported the use of marijuana for medical purposes and, therefore, wished to emphasize that the proposed rule affected the CSA status of Marinol--not that of marijuana, which remains a schedule I controlled substance.

The one commenter who objected to the proposed rule, and requested a hearing thereon, asserted that Marinol should not be transferred to schedule III unless and until marijuana and all other THC-containing drugs are simultaneously and likewise rescheduled.

This commenter asserted that Marinol has the same potential for abuse as marijuana and all other THC-containing drugs. This commenter agreed with the proposed rule that Marinol's potential for abuse is less than the "high potential for abuse" commensurate with schedules I and II of the CSA. Accordingly, this commenter agreed that Marinol should be transferred to a less restrictive schedule than schedule II.

This commenter asserted that the CSA prohibited transferring Marinol to a less restrictive schedule unless marijuana and all THC-containing drugs are simultaneously transferred to the same schedule. DEA has determined that this commenter's objections are based on a misinterpretation of the CSA, which can be addressed, as a matter of law, without conducting a fact-finding hearing.

Accordingly, as this commenter presented no material issues of fact, DEA denied this commenter's request for a hearing.

Relying on the scientific and medical evaluation and scheduling recommendations of the Assistant Secretary for Health, and based on DEA's independent review thereof, the Deputy Administrator of the DEA, pursuant to 21 U. Schedule III regulations will, among other things, allow five prescription refills in six months and lessen record keeping requirements and distribution restrictions.

The schedule III control of Marinol will become effective July 2, , except that certain regulatory provisions governing registrants who handle Marinol will take effect as indicated below. In the event that the regulations impose special hardships on the registrants, the DEA will entertain any justified request for an extension of time to comply with the schedule III regulations regarding Marinol. The applicable regulations are as follows. In accordance with the provisions of the CSA 21 U.

Marinol is a prescription drug used to treat nausea due to cancer chemotherapy and AIDS wasting. Handlers of Marinol are likely to handle other controlled substances used to treat cancer or AIDS which are already subject to the regulatory requirements of the CSA. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of This rule is not a major rule as defined by section of the Small Business Regulatory Enforcement Fairness Act of This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

Cesamet, like dronabinol-containing products, is indicated for nausea associated with cancer chemotherapy. 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.

However, the use of unapproved cannabis and cannabis-derived products can have unpredictable and unintended consequences, including serious safety risks. Also, there has been no FDA review of data from rigorous clinical trials to support that these unapproved products are safe and efficacious for the various therapeutic uses for which they are being used. FDA understands the need to develop therapies for patients with unmet medical needs, and does everything it can to facilitate this process.

FDA has programs such as Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review that are designed to facilitate the development of and expedite the approval of drug products. Through these programs and the drug approval process, FDA supports 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.

As a part of this role, the FDA supports those in the medical research community who intend to study cannabis by:. 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 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.

An IND includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA also requires obtaining the informed consent of trial subjects and human subject protection in the conduct of the clinical trials.

The BRT serves as an expert resource on botanical issues and has developed the Botanical Drug Development Guidance for Industry to assist those pursuing drug development in this area. FDA encourages researchers to request a Pre-Investigational New Drug application PIND meeting to discuss questions related to the development of a specific cannabis-derived and cannabis-related drug product.

Please note that certain cultivars and parts of the Cannabis sativa L. However, in December , the Agriculture Improvement Act of also known as the Farm Bill removed hemp, a type of cannabis that is very low in THC cannabis or cannabis derivatives containing no more than 0.

This change in the law may result in a more streamlined process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, a result which could speed the development of new drugs containing hemp. Conducting clinical research using cannabis-derived substances that are considered controlled substances under the CSA often involves interactions with several federal agencies.

For example:. Alternatively, an IND submission would need to contain all necessary CMC data characterizing their study drug and ensuring it is safe for use in humans. The sponsor must wait 30 calendar days following IND submission before initiating any clinical trials, unless FDA notifies the sponsor that the trials may proceed sooner. During this time, FDA has an opportunity to review the submission for safety to assure that research subjects will not be subjected to unreasonable risk.