NOTICES
DEPARTMENT OF HEALTH
Rescheduling of Substance: Certain FDA-Approved Drugs Containing Cannabidiol as Schedule V Controlled Substances
[48 Pa.B. 6629]
[Saturday, October 13, 2018]The Secretary of Health (Secretary) of the Department of Health (Department) is issuing this final order rescheduling certain drug products that have been approved by the United States Food and Drug Administration (FDA) and that contain cannabidiol (CBD) in Schedule V of The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). This final order places in Schedule V certain FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols—specifically Epidiolex and any generic versions of the same formulation that might be approved by the FDA in the future. Significantly, however, the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in Schedule I of the act.
Under section 3 of the act, the rescheduling of a controlled substance to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. 35 P.S. § 780-103(c)(1).
Background
On September 28, 2018, the United States Drug Enforcement Administration (DEA) rescheduled Epidiolex as a Schedule V drug under the Federal Controlled Substances Act (CSA) (21 U.S.C.A. §§ 801—971). The DEA's rescheduling order was effective upon its publication in the Federal Register at 83 FR 48950 (September 28, 2018.)
As the DEA noted in its rescheduling order, the United States is a party to the Single Convention on Narcotic Drugs, 1961 (Single Convention), and other internationalconventions designed to establish effective control over international and domestic traffic in controlled substances. 21 U.S.C.A. § 801(7). The enactment and enforcement of the CSA are the primary means by which the United States carries out its obligations under the Single Convention. Section 811(d) of the CSA, which relates to scheduling of controlled substances under Federal law, directly references the Single Convention. Under section 811(d)(1) of the CSA, Congress directed the Attorney General (and the Administrator of DEA, by delegation) to ensure that compliance by the United States with our Nation's obligations under the Single Convention is given top consideration when it comes to scheduling determinations.
On June 25, 2018, the FDA announced that it approved a drug that is subject to control under the Single Convention. Specifically, the FDA announced that it approved the drug Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm. Epidiolex is an oral solution that contains CBD extracted from the cannabis plant. This is the first FDA-approved drug made from the cannabis plant. Now that Epidiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in Schedule I of the CSA. See 21 U.S.C.A. § 812(b) (indicating that while substances in Schedule I have no currently accepted medical use in treatment in the United States, substances in Schedules II—V do); see also United States v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483, 491-92 (2001) (same). The DEA therefore took the appropriate scheduling action to remove the drug from Schedule I, while acknowledging the relevant requirements of the Single Convention.
Under the Single Convention treaty, cannabis, cannabis resin and extracts and tinctures of cannabis are listed in Schedule I. The cannabis plant contains more than 100 cannabinoids. Among these are tetrahydrocannabinols (THC) and CBD.1 Material that contains THC and CBD extracted from the cannabis plant falls within the listing of extracts and tinctures of cannabis for purposes of the Single Convention. Thus, the material, which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.
In making its rescheduling determination, and while not required, DEA sought an evaluation and recommendation from the United States Department of Health and Human Services (HHS) with respect to the Epidiolex formulation. In response, HHS advised DEA that it found the Epidiolex formulation to have a very low potential for abuse and, therefore, recommended that, if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in Schedule V of the CSA. Accordingly, DEA accepted HHS's recommendation and ordered that the Epidiolex formulation (and any future FDA-approved generic versions of such formulation made from cannabis) be placed in Schedule V of the CSA.
The Single Convention also obligates parties to require a permit to import and export drugs listed in Schedule I of the Convention. This permit requirement applies to a drug product containing CBD extracted from the cannabis plant because, as previously indicated, such a product is a Schedule I drug under the Single Convention. Under the CSA and DEA regulations, the import/export permit requirement applies to any controlled substance in Schedule I and II, as well as certain controlled substances in Schedules III, IV and V. See 21 U.S.C.A. §§ 952 and 953; 21 CFR 1312.11, 1312.12, 1312.21 and 1312.22.
The DEA noted that, to comport with section 811(d) of the CSA, the Epidiolex formulation in Schedule V of the CSA will still be subject to all import and export requirements of the permit requirement. At present, the cannabis used to make Epidiolex is grown in the United Kingdom, and the drug is imported into the United States in finished dosage form. The Epidiolex formulation had until now been a Schedule I controlled substance, and importing the drug from its foreign production facility has always been subject to the permit requirement. To ensure this requirement remains in place (and thus to prevent any lapse in compliance with the requirements of the Single Convention), the DEA will amend its regulations (21 CFR 1312.30 (relating to Schedule III, IV, and V non-narcotic controlled substances requiring an import and export permit)) to add the Epidiolex formulation to the list of nonnarcotic Schedule III—V controlled substances that are subject to the import and export permit requirement.
As previously indicated, for drugs listed in Schedule I of the Single Convention, parties are obligated to require that licensed manufacturers of the drugs obtain quotas specifying the amounts of the drugs they may manufacture. The purpose of this treaty requirement is to prevent excessive production and accumulation beyond that necessary to satisfy legitimate needs. Under the DEA's rescheduling order, the United States will continue to meet this obligation because the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in Schedule I of the CSA and thus be subject to all applicable quota provisions under 21 U.S.C.A. § 826.
Requirements for Handling FDA-Approved Products Containing CBD
As noted, until now, Epidiolex has been a Schedule I controlled substance. By virtue of the DEA's order, Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a Schedule V controlled substance. Thus, all persons in the distribution chain who handle Epidiolex in the United States (importers, manufacturers, distributors and practitioners) must comply with the requirements of the CSA and DEA regulations relating to Schedule V controlled substances.
Significantly, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C.A. § 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a Schedule I controlled substance under the CSA. Thus, persons who handle the items will continue to be subject to the requirements of the CSA and DEA regulations relating to Schedule I controlled substances.
Legal Authority and Action under the Act
Under section 3 of the act, the Secretary shall control all substances listed in Schedules I—V of the act. Under section 3(c) of the act, if the Secretary finds that the health and safety of the public will not be adversely affected, the Secretary is authorized to reschedule any substance to coincide with Federal law, including the CSA (Pub.L. No. 91-513, 84 Stat. 1236; 21 U.S.C.A. §§ 801 et seq.), regulations promulgated under 21 CFR Chapter 2 (relating to drug enforcement administration, Department of Justice) or any Federal judicial order. 35 P.S. § 780-103(c)(1). The rescheduling of a controlled substance to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. Id.
Based upon the DEA's September 28, 2018, final order rescheduling the Epidiolex formation (and any future FDA-approved generic versions of such formulation made from cannabis), the Secretary is exercising her authority to reschedule the Epidiolex formation from Schedule I to Schedule V under the act. Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols in Schedule V. The rescheduling of the Epidiolex formation (and any future FDA-approved generic versions of such formulation made from cannabis) to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. 35 P.S. § 780-103(c)(1).
To revise 28 Pa. Code § 25.72 (relating to schedules of controlled substances) to conform to this final order issued by the Secretary under section 3(c) of the act to reschedule as a Schedule V drug Epidiolex (and any future FDA-approved generic versions of such formulation made from cannabis), the Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.
Accessibility
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the Department of Health, Bureau of Community Program Licensure and Certification, Division of Home Health, Drug, Device and Cosmetic Program, 132A Kline Plaza, Harrisburg, PA 17104, (717) 783-1379, or for speech and/or hearing-impaired persons V/TT (717) 783-6514 or Pennsylvania AT&T Relay Service at (800) 654-5984.
RACHEL L. LEVINE, MD,
Secretary
[Pa.B. Doc. No. 18-1599. Filed for public inspection October 12, 2018, 9:00 a.m.] _______
1 As the FDA noted in its June 25, 2018, announcement, CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria, the ''high,'' that comes from THC. It is THC (and not CBD) that is the primary psychoactive component of marijuana.
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