PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 25]
Schedules of Controlled Substances
[30 Pa.B. 3945] The Department of Health (Department) proposes to amend the schedules of controlled substances under the powers and duties contained in The Controlled Substance, Drug, Device, and Cosmetic Act (act) (35 P. S. §§ 780-101--780-144).
The Department proposes to amend § 25.72 (relating to schedules of controlled substances) to reschedule the substance dronabinol from Schedule II to Schedule III, to read as set forth in Annex A.
A. Purpose of the Amendment
The act recognizes the fact that there is a need to control substances which have potential for abuse while also recognizing that some of those substances have medical uses. The act provides for a system of five schedules of controlled substances as a means of grouping potentially dangerous substances based on their differing potentials for abuse and on their potential for medical use. Penalties for illegal use of the controlled substances vary according to the schedule on which the substance is listed. The health and safety of the public is protected by having a substance placed on the proper schedule. Additionally, proper scheduling ensures appropriate enforcement when a substance is abused or otherwise used illegally.
The act requires that a controlled substance be placed in Schedule II when: (1) there is a high potential for abuse; (2) there is currently accepted medical use in the United States or currently accepted medical use with severe restrictions; and (3) abuse may lead to severe psychic or physical dependence.
The act requires that a controlled substance be placed in Schedule III when: (1) there is a potential for abuse less than the substances listed in Schedules I and II; (2) there is well documented and currently accepted medical use in the United States; and (3) abuse may lead to moderate or low physical dependence or high psychological dependence.
The proposed rulemaking reschedules dronabinol, previously listed in Schedule II of the schedule of controlled substances, to Schedule III.
B. Requirements of the Amendment
The Drug, Device and Cosmetic Board (Board) met on December 9, 1999. The meeting notice was published in the Pennsylvania Bulletin at 29 Pa.B. 5957 (November 20, 1999). The Board heard the petition of Roxane Laboratories, Inc., which requested that dronabinol be rescheduled from Schedule II to Schedule III. The Board unanimously approved a motion to authorize the Secretary of Health to reschedule the substance. This motion was based on several factors:
1. The United States Drug Enforcement Agency (DEA) rescheduled dronabinol from a Schedule II to a Schedule III substance under the Controlled Substances Act (63 FR 59,751). Both DEA and the Food and Drug Administration (FDA) determined that dronabinol should be rescheduled based on an eight-factor analysis of the scientific and medical data as required by Federal law.
2. The DEA and FDA determined that there is little evidence of actual abuse of dronabinol.
3. In 1996 the Haight Ashbury Clinics, Inc., conducted a study on the abuse potential of dronabinol. No evidence of current abuse or diversion of dronabinol among populations having access to the medicine was found.
4. Cannabis dependent populations have demonstrated no interest in abuse of dronabinol. Studies demonstrate that dronabinol is not a substitute for the problem of marijuana abuse or misuse.
5. The Haight Ashbury study concluded that there is no street market for dronabinol, and no evidence of any diversion of dronabinol for sale as a street drug.
6. A review of the Drug Abuse Warning Network (DAWN) data from 1988 to 1994 shows no reports of dronabinol misuse.
7. The DEA and FDA scientific and medical evaluation determined that dronabinol had only a low to moderate potential to lead to physical dependence and an abuse potential less than Schedule II drugs.
The Secretary of Health, upon advice of the Board, finds that placing dronabinol on Schedule III will permit patients to obtain prescription refills and possibly reduce trips to physicians' offices. This action will allow pharmacies to accept telephone or facsimile prescriptions from physicians rather than mandated written prescriptions. This action will also allow pharmacies to obtain the drug product more quickly for patients. The proposed amendment to the schedules of controlled substances follows similar actions by DEA on July 2, 1999. Dronabinol was approved for marketing by the FDA on May 31, 1985, for use as a treatment for nausea and vomiting in cancer therapy patients who have failed to respond adequately to conventional antiemetic treatments. In 1992, dronabinol was approved by the FDA for use in the treatment of anorexia associated with weight loss of patients with AIDS. Studies have shown that dronabinol has improved the lives of cancer and AIDS patients. Dronabinol has demonstrated short and long term safety and effectiveness relative to appetite stimulation in AIDS patients. Patients who received dronabinol also experienced a stabilization of weight.
C. Affected Persons
Persons who depend on this substance for medical treatment will be able to obtain prescription refills, not available with Schedule II controlled substances. Further, physicians would be permitted to have prescriptions filled by telephone, again, not available with Schedule II substances. The patients would benefit in that they would be able to obtain the prescriptions more quickly and efficiently as a result of reduced visits to physicians' offices.
D. Fiscal Impact
The proposed amendment to the schedules of controlled substances will have no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public.
E. Paperwork Requirements
A system already exists for the handling of controlled substances under the act and the proposed amendment will not increase paperwork.
F. Effective Date/Sunset Date
The amendment will become effective immediately upon publication as final rulemaking. The Department's regulations are continually monitored and updated as needed. There is no sunset date.
G. Statutory Authority
The amendment to the schedules of controlled substances is proposed under sections 3 and 4 of the act (35 P. S. §§ 780-103 and 780-104.) The amendment is also proposed under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on July 26, 2000, the Department submitted a copy of the proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare. In addition to submitting the proposed rulemaking, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, if IRRC has objections to any portion of the proposed rulemaking, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by the portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulations, by the Department, the General Assembly and the Governor, of objections raised.
I. Contact Person
Interested persons are invited to submit questions, comments, suggestions or objections regarding the proposal to: John C. Hair, Director, Bureau of Community Program Licensure and Certification, Department of Health, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-8665, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed rulemaking may do so by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]. Persons who require an alternative format of this document may contact Mr. Hair so that necessary arrangements may be made.
ROBERT S. ZIMMERMAN, Jr.,
SecretaryFiscal Note: 10-163. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS § 25.72. Schedules of controlled substances.
* * * * * (c) Schedule II. In determining that a substance comes within this schedule, the Secretary will find: a high potential for abuse; currently acceptable medical use in the United States; or currently accepted medical use with severe restrictions and abuse may lead to severe psychic or physical dependence. The following substances are included in this schedule:
* * * * * (5) A material, compound, mixture or preparation, unless specifically excepted, which contains a quantity of:
* * * * * [(iv) Dronabinol--synthetic--in sesame oil and encapsulated in a soft gelatin capsule but only those drug products approved by the United States Food and Drug Administration.
(v)] (iv) Nabilone.
* * * * * (d) Schedule III. In determining that a substance comes within this schedule, the Secretary will find: a potential for abuse less than the substances listed in Schedule I and II; well documented and currently accepted medical use in the United States; and abuse may lead to moderate or low physical dependence. The following classes of controlled substances are included in this schedule:
* * * * * (9) A material, compound, mixture or preparation, unless specifically excepted, which contains a quantity of Dronabinol--synthetic--in sesame oil encapsulated in a soft gelatin capsule but only those drug products approved by the United States Food and Drug Administration.
* * * * *
[Pa.B. Doc. No. 00-1321. Filed for public inspection August 4, 2000, 9:00 a.m.]
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