NOTICES
Rescheduling of Controlled Substance: Clobazam from Schedule I to Schedule IV Classification
[42 Pa.B. 1929]
[Saturday, April 7, 2012]The Department of Health (Department) provides notice that the Secretary of Health (Secretary), with the authorization of the Pennsylvania Drug, Device and Cosmetic Board (Board), has acted to reclassify the controlled substance clobazam from a Schedule I controlled substance to a Schedule IV controlled substance under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144) (act). The Secretary took this action on March 27, 2012, under section 3(c) of the act (35 P. S. § 780-103(c)) (relating to authority to control). The reclassification was effective immediately upon the Secretary's action.
Background
The Department learned on March 26, 2012, that the United States Food and Drug Administration (FDA) recently had approved the drug OnfiTM (chemical name: clobazam) for the treatment of a rare but severe form of epilepsy in adults and in children 2 years of age and older. Under Federal law, clobazam is a Schedule IV controlled substance and, therefore, may be properly prescribed for appropriate medical treatments.
In the Commonwealth, by contrast, clobazam had been a Schedule I controlled substance under 28 Pa. Code § 25.72 (relating to schedules of controlled substances). See 28 Pa. Code § 25.72(b)(6)(vi) (relating to Schedule I). Clobazam had been listed as a Schedule I controlled substance under Department regulations since 1986. Thus, under Commonwealth law, until the Secretary acted to reclassify it, clobazam had been illegal to possess, administer, dispense, prescribe or distribute.
At the time that the Department originally classified clobazam as a Schedule I controlled substance in 1986, it met State law criteria for that classification in the act and implementing Department regulations, 28 Pa. Code Chapter 25 (relating to controlled substances, drugs, devices, and cosmetics). Under section 4(1) of the act (35 P. S. § 780-104(1)) (relating to schedules of controlled substances—Schedule I) and 28 Pa. Code § 25.72(b), the factors to determine whether a substance is classified as a Schedule I controlled substance are the following:
1. A high potential for abuse.
2. No currently accepted medical use in the United States.
3. A lack of accepted safety for use under medical supervision.
Under section 4(4) of the act (35 P. S. § 780-104(4)) (relating to Schedule IV) and 28 Pa. Code § 25.72(e) (relating to Schedule IV), the factors to determine whether a substance is classified as a Schedule IV controlled substance are as follows:
1. A low potential for abuse relative to the substances listed in Schedule III.
2. Currently accepted medical use in the United States.
3. Limited physical or psychological dependence liability relative to the substances listed in Schedule III.
With the recent FDA action approving OnfiTM (chemical name: clobazam) for the treatment of epilepsy with a Schedule IV classification at the Federal level, clobazam now has an accepted medical use; and it is accepted for safe use under medical supervision.
Legal Authority and Action
Under section 3(c) of the act (35 P. S. § 780-103(c)), the Secretary is authorized to reschedule any controlled substance when specifically authorized by the Board. The Board is established by section 31 of the act as a departmental administrative board of the Department and is chaired by the Secretary. See 35 P. S. § 780-131 (relating to board creation).
When the Department learned of the action of the FDA to approve the use of OnfiTM (chemical name: clobazam) to treat certain forms of epilepsy, the Secretary acted as chair to convene an emergency meeting of the Board on March 27, 2012. The purpose of the emergency meeting was to determine whether, in consideration of the FDA's action regarding OnfiTM (chemical name: clobazam), clobazam should be rescheduled under Commonwealth law as a Schedule IV controlled substance, instead of a Schedule I controlled substance.
At the emergency meeting of the Board, a motion to reschedule OnfiTM (chemical name: clobazam) as a Schedule IV controlled substance was presented by board member Joan B. Tarloff, Ph.D. (Pharmacist on the Board), Professor and Interim Chair, Department of Pharmaceutical Sciences, Philadelphia College of Pharmacy, University of the Sciences. The Secretary of Health, Eli N. Avila, seconded the motion. The Board proceeded to vote unanimously to authorize the rescheduling of clobazam as a Schedule IV controlled substance. The Secretary then acted immediately under section 103(c) of the act to effect the rescheduling.
To revise 28 Pa. Code § 25.72 to conform to the action taken by the Secretary under section 103(c) of the act to reschedule clobazam as a Schedule IV controlled substance, 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 via the 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 the Pennsylvania AT&T Relay Service at (800) 654-5984.
ELI N. AVILA, MD, JD, MPH, FCLM,
Secretary
[Pa.B. Doc. No. 12-617. Filed for public inspection April 6, 2012, 9:00 a.m.]
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