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NABP e-News September 8, 2006
Federal Court Says Compounded Drugs Are Not New Drugs
On August 30, the United States District Court for the Western District of Texas (5th Circuit) issued an order in the case of Medical Center Pharmacy, et al v Gonzalez, et al (No.MO-04-CV-130, in the United States District Court for the Western District of Texas, Midland-Odessa Division) declaring pharmacy compounding “an approved and legal practice” and that compounded drugs are not “new drugs” under the US Food, Drug and Cosmetic Act. The Court based its decision on its finding that the advertising provisions of §353a of the Food and Drug Administration Modernization Act of 1997, which had been declared unconstitutional by the US Supreme Court in 2002 (Thompson v Western States Medical Center, 535 U.S. 357), are severable from the statute and that “the remainder of the statute remains in full effect.”
In his opinion, Judge Robert Junell found Section 353a to implicitly exempt compounded drugs from the Food and Drug Administration’s new drug approval process. He further stated that this exemption is limited to compounds made in reasonable quantities upon receipt of a valid prescription for an individual patient from a licensed practitioner. He stated that drugs compounded in large quantities before a prescription order is received do not fall within this narrow exemption. In the Western States case, the 9th Circuit Appellate Court found the advertising provisions of §353a unconstitutional but not severable and declared the entire section invalid. The US Supreme Court did not address the severability question in the 2002 case. Additionally, Judge Junell found compounding drugs from bulk ingredients for non-food producing animals to be a legal activity.
DEA Issues Notice of Proposed Rule Making and Policy Statement Regarding Schedule II Controlled Substances and Prescriptions
In the September 6 Federal Register, Drug Enforcement Administration published a notice of proposed rule making proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially for the same Schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance. DEA is requesting public comment on this proposed rule on or before November 6, 2006. In the same Federal Register, DEA also released a policy statement, "Dispensing Controlled Substances for the Treatment of Pain" in response to the Agency's previous solicitation of comments on the subject of dispensing controlled substances for the treatment of pain. The policy statement elaborates on the legal requirements and the Agency's policy in response to many of the comments the Agency received.
FDA Warns Consumers not to Purchase Rx Drugs from Certain Canadian Web Sites
In an August 30 press release, the US Food and Drug Administration advised consumers not to purchase or use prescription drugs from Web sites that have orders filled by Manitoba, Canada-based Mediplan Prescription Plus Pharmacy or Mediplan Global Health. The agency is investigating reports that these companies are selling counterfeit versions of 10 drug products, including Lipitor®, Crestor®, Celebrex®, and Propecia®. To obtain a copy of the press release, which lists the Web sites that are operated by or have order fulfillment through Mediplan, visit http://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html
Professor J. Lyle Bootman and Professor Emeritus Charles D. Hepler to Speak at NABP’s Fall Educational Conference
NABP is pleased to provide attendees with the opportunity to hear the renowned Drs J. Lyle Bootman, PhD, and Charles D. Hepler, PhD, speak during the continuing education sessions at the Fall Educational Conference, to be held November 3-4 in Savannah, GA. Dr Bootman, dean and professor at the University of Arizona College of Pharmacy, will discuss the challenges faced in developing, improving, and maintaining patient safety and quality care at the continuing education session entitled "A National Agenda to Improve Patient Safety and Quality Care: Implications for the Boards of Pharmacy." In addition, Dr Bootman will discuss the major recommendations of the recent Institute of Medicine report Preventing Medication Errors: Quality Chasm Series, which he co-authored. Dr Hepler, eminent professor emeritus for the University of Florida College of Pharmacy's Department of Pharmacy Health Care Administration, will discuss the professional and practice-related implications of medication therapy management and its specific relevancy to the boards of pharmacy during the CE session "The Delivery of Pharmacist Care by the Non-Pharmacist: Legal, Regulatory, and Professional Implications." For further information on Fall Educational Conference programming including CE descriptions, visit NABP's Web site at http://www.nabp.net.
