|Update on PPA|
There has been a lot of confusion within the veterinary community about a veterinarian’s recordkeeping and tracking obligations when dispensing prion or any other drug containing phenylpropanolamine hydrochloride (PPA) for a patient.
While PPA is not a controlled substance, it is a listed chemical, and subject to federal regulation under the Combat Methamphetamine Epidemic Act of 2005.There are a number of stringent requirements in that act, including the need to request ID from the purchaser; a requirement that the purchaser sign a log maintained by a retail seller, which must be kept for two years; and the need for a retail seller to self-certify with the AG that all individuals selling the drug know and understand the restrictions.
Our research indicated that these requirements apply to OTC sales of non-prescription drugs containing PPA. While it appeared that the requirements did not apply to veterinary prescription drugs containing PPA, NYSVMS sought confirmation from the U.S. Drug Enforcement Agency, through AVMA, that veterinarians dispensing prescription drugs containing PPA were not subject to the requirements in the federal Combat Methamphetamine Epidemic Act.
DEA has now verified via letter to the AVMA that the requirements for tracking non-prescription PPA sales do not apply to veterinary dispensing of prescription drugs containing PPA.
DEA’s letter to AVMA states, "The Combat Methamphetamine Epidemic Act (CMEA) became law on March 6, 2006, imposing new requirements governing the sale of scheduled listed chemical products (SLCPs). Title 21 §C.F.R. 1300.02(b) defines the term SLCP as a product that (1) contains ephedrine, pseudoephedrine, or PPA and (2) may be marketed or distributed in the United States under the Federal Food, Drug and Cosmetic Act as a nonprescription drug. The provision of the CMEA do not apply to FDA-approved prescription drug products that contain ephedrine, pseudoephedrine, or PPA that a practitioner prescribes, administers, or dispenses for a legitimate medical purpose in the usual course of his or her professional practice. As a state may have passed a law or regulation that placed additional requirements regarding the handling of drug products that contain ephedrine, pseudoephedrine, or PPA, DEA recommends each veterinarian contact their state veterinary board to ensure compliance. When federal law or regulations differ from state law or regulations, a practitioner is required to abide by the more stringent aspects [of] each.”
New York State has no additional requirements for PPA sales beyond those imposed by this federal regulation; veterinarians in this state can simply follow the federal rule when dispensing prescription PPA drugs.
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