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§ 780-103. Authority to control

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: August 8, 2016

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 6. The Controlled Substance, Drug, Device and Cosmetic Act (Refs & Annos)
Effective: August 8, 2016
35 P.S. § 780-103
§ 780-103. Authority to control
(a) The secretary shall control all substances listed in Schedules I through V of this act1 and may, by regulation, upon his own motion or on the petition of any interested party, add a substance as a controlled substance.2 Such regulations shall be adopted in accordance with the act of July 31, 1968 (P.L. 769, No. 240),3 known as the “Commonwealth Documents Law.” Before so doing, the secretary shall request the advice in writing from the board whether a substance should be added as a controlled substance. Such advice shall be rendered to the secretary within a reasonable time. The secretary shall consider with respect to each substance hereafter controlled:
(1) Its actual or relative potential for abuse;
(2) Scientific evidence of its pharmacological effect, if known;
(3) State of current scientific knowledge regarding the substance;
(4) Its history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) The risk there is to the public health;
(7) Its psychic or physiological dependence liability;
(8) Whether the substance is controlled under Federal law; and
(9) Whether the substance is an immediate precursor of a substance already controlled under this section. After considering the above factors, the secretary shall make findings with respect thereto and shall issue a regulation controlling the substance if he finds that the substance has a potential for abuse.
(b) If the secretary designates a substance as an immediate precursor, substances which are precursors of the controlled precursor shall not be subject to control solely because they are precursors of the controlled precursor.
(c) Notwithstanding subsection (a), if the secretary finds that the health and safety of the public will not be adversely affected, the secretary may:
(1) Reschedule any controlled substance to coincide with Federal law, including the Controlled Substances Act (Public Law 91-513, 84 Stat. 1236),4 regulations promulgated under 21 CFR Ch. 2 (relating to drug enforcement administration, department of justice) or any Federal judicial order. The secretary shall publish a notice in the Pennsylvania Bulletin of the rescheduling of a controlled substance under this clause. The rescheduling of the controlled substance to a higher schedule may not take effect earlier than thirty days after publication of the notice in the Pennsylvania Bulletin. The rescheduling of a controlled substance to a lower schedule may take effect upon publication in the Pennsylvania Bulletin.
(2) Exclude any substance or remove any controlled substance from any schedule, provided that the substance or controlled substance has been approved for over-the-counter use without a prescription under Federal law, including the Federal Food, Drug and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301, et seq.), regulations promulgated under 21 CFR Ch. 1 (relating to food and drug administration, department of health and human services) or any Federal judicial order.
(d) If the secretary finds that the scheduling of a substance on a temporary basis is necessary to avoid an imminent hazard to public safety, the secretary may, by publishing a final notice in the Pennsylvania Bulletin and without regard to the requirements of subsection (a), schedule a substance under one of the schedules in section 45 if the substance is not listed in any other schedule in section 4 or 28 Pa. Code §§ 25.72 (relating to schedules of controlled substances) and 25.75 (relating to paregoric) and if no exception or approval is in effect for the substance under section 505 of the Federal Food, Drug and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 355). The following apply:
(1) A final order may not be issued before the expiration of fourteen days after both:
(i) The date of publication in the Pennsylvania Bulletin of a proposed notice of the intention to issue a final notice and the grounds upon which the order is to be issued.
(ii) The date the secretary transmitted the notice to the Attorney General as required by clause (4).
(2) The scheduling of a substance under this subsection shall expire at the end of one year from the date of publication of the final notice scheduling of the substance except that the secretary may, during the pendency of proceedings under subsection (a) with respect to the substance, extend the temporary scheduling for up to one additional year by publishing a subsequent notice in the Pennsylvania Bulletin prior to the expiration of the initial notice.
(3) When issuing a proposed notice under clause (1), the secretary shall be required to consider, with respect to the finding of an imminent hazard to public safety, only those factors set forth in subsection (a)(4), (5), (6) and (8), except that, if clause (8) has been met regarding the temporary or permanent scheduling of a specific substance under Federal law, the secretary shall be authorized to temporarily schedule the substance without regard to clauses (4), (5) and (6).
(4) The secretary shall transmit the proposed notice issued under clause (1) to the Attorney General. The Attorney General shall have thirty days from receipt of the proposed notice to provide written comments, if any, on relevant issues, including actual abuse, diversion from legitimate channels and clandestine importation, manufacture or distribution. In issuing a final notice under this subsection, the secretary shall take into consideration any comments submitted by the Attorney General.
(5)(i) Except as provided in subclause (ii), during the time period that a substance is temporarily scheduled, the secretary shall proceed with the permanent scheduling of the substance pursuant to the requirements under subsection (a).
(ii) If a substance has been temporarily scheduled and the secretary proceeds with permanent scheduling, the secretary shall only be required to proceed under section 5(a) of the act of June 25, 1982 (P.L. 633, No. 181),6 known as the “Regulatory Review Act,” by submitting final omitted regulations.
(iii) A final notice issued under clause (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to the substance or the enactment of law by the General Assembly permanently scheduling the substance.
(iv) While the substance is temporarily scheduled, if the secretary determines that a substance should not be permanently scheduled, and no law has been enacted by the General Assembly to permanently schedule the substance, the secretary shall publish a notice in the Pennsylvania Bulletin with a rationale as to why the substance is not being permanently scheduled. Upon publication of the notice, the substance shall no longer be considered a controlled substance. Withdrawal of a temporarily scheduled substance under this subclause shall not affect any criminal proceeding or civil action initiated based on the temporary scheduling.
(6) Temporary scheduling of a substance by the secretary under this subsection shall not be subject to section 612 of the act of April 9, 1929 (P.L. 177, No. 175),7 known as “The Administrative Code of 1929,” the “Commonwealth Documents Law,” the act of October 15, 1980 (P.L. 950, No. 164),8 known as the “Commonwealth Attorneys Act,” or the “Regulatory Review Act.”9
(7) A proposed or final notice issued by the secretary under this subsection shall not be subject to judicial review.
(e) At the time of publication by the secretary of a notice in the Pennsylvania Bulletin under subsection (c) or (d), the secretary shall also transmit the notice to the ABC-MAP Board.
(f) As used in this section, the term “substance” shall include any group of substances, materials, mixtures, compounds, salts, isomers, salts of isomers, analogs, homologues or homologous series.

Credits

1972, April 14, P.L. 233, No. 64, § 3, eff. June 14, 1972. Amended 2016, June 8, P.L. 258, No. 37, § 1, effective in 60 days [Aug. 8, 2016].

Footnotes

35 P.S. § 780-104.
See 28 Pa. Code § 25.72 for schedules of controlled substances including those added by the Secretary of Health.
45 P.S. § 1102 et seq.
21 U.S.C.A. § 801 et seq.
35 P.S. § 780-104.
71 P.S. § 745.5.
71 P.S. § 232.
71 P.S. § 732-101 et seq.
71 P.S. § 745.1 et seq.
35 P.S. § 780-103, PA ST 35 P.S. § 780-103
Current through 2020 Regular Session Act 77. Some statute sections may be more current, see credits for details.
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