Legislative, Regulatory and Bulletin Updates
Thursday, October 25, 2018
Posted by: Katie Maher
PCNP is dedicated to keep its members informed of legislation and activity in Harrisburg affecting nurse practitioners. Please see below for pertinent updates from the Oct. 14-20, 2018, edition of The Pennsylvania Bulletin.
Rescheduling of Substance: Certain FDA-Approved Drugs Containing Cannabidiol as Schedule V Controlled Substances
The Department of Health (Department) provided notice that the Secretary of Health (Secretary) of the 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) because under section 3 of the act, the Secretary shall control all substances listed in Schedules I—V of the act. Thus, 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.
Hence, based upon the DEA's Sept. 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). The Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.
Medical Marijuana Academic Clinical
The Department of Health (Department) provided notice that it approved 8 institutions approved as Medical Marijuana Academic Clinical Research Centers - 8 in total. Specifically, under 28 Pa. Code § 1211.25(d) (relating to certifying ACRCs), the Department has certified the following Academic Clinical Research Centers as eligible to enter into a contract with a Clinical Registrant after the Clinical Registrant's application has been approved by the Department (see 48 Pa.B. 5423 (Aug. 25, 2018) for Clinical Registrant application approval process opened on Oct. 4, 2018): Lake Erie College of Osteopathic Medicine (LECOM); Lewis Katz School of Medicine at Temple University; Penn State College of Medicine; Drexel University College of Medicine; University of Pittsburgh School of Medicine; Perelman School of Medicine at the University of Pennsylvania; The Philadelphia College of Osteopathic Medicine; Sidney Kimmel Medical College at Thomas Jefferson University.
Traumatic Brain Injury Advisory Public Board Meeting: Participate on Nov. 2 in Harrisburg
The Department of Health provide notice that the Traumatic Brain Injury Advisory Board (Board), established under section 1252 of the Federal Traumatic Brain Injury Act of 1996, will hold a public meeting on Friday, Nov. 2, 2018, from 10 a.m. to 3 p.m. The meeting will be held in the large conference room of the Community Center, 2nd Floor, Giant Food Store, 2300 Linglestown Road, Harrisburg, PA 17110. This quarterly meeting will provide updates on a variety of topics including the number of people served by HIP. In addition, meeting participants will discuss budgetary and programmatic issues, community programs relating to traumatic brain injury and available advocacy opportunities. Additional information can be provided by contacting Nicole Johnson, Division of Community Systems Development and Outreach, (717) 772-2763. PCNP members are encouraged to attend, if possible.