Sunday, March 31, 2013

United States: FDA Emphasizes Patient-Specific Prescriptions

The FDA's reliance on the compliance policy guide as a basis for the need for a patient-specific prescription is also noteworthy.
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date against compounding pharmacies on the issue of patient-specific prescriptions. The FDA stated that the receipt of a valid prescription for an individually identified patient prior to the distribution of compounded drugs is "relevant" to Section 503A (21 U.S.C. 353a) of the Food and Drug Administration Modernization Act (FDAMA) and the compliance policy guide FDA issued on compounding issued in 2002 (CPG). Based on Medi-Fare Drug's alleged lack of patient specific prescriptions, the FDA also stated the compounds were unapproved new drugs that had not been through the drug approval process.
The FDA's use of FDAMA is noteworthy in light of a circuit split that created conflicting decisions regarding FDAMA. An amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), FDAMA regulates compounds. FDAMA exempts compounds from certain FDCA requirements if the compounds, among other things, are prepared "on prescription order for [an] individual patient."1 FDAMA also contained an advertising ban, which the United States Supreme Court struck down as unconstitutional inWestern States.2 The Ninth Circuit in Western States found the advertising provision could not be severed from the remainder of FDAMA, and therefore found the entire statute unconstitutional.3 In 2008, the Fifth Circuit disagreed with the Ninth Circuit, finding FDAMA's advertising provision could be severed, thereby resurrecting the remainder of FDAMA and declaring it good law.4 Since that time, the FDA has applied FDAMA in the Fifth Circuit and to the pharmacies who were plaintiffs in the suit. The FDA has not applied FDAMA to the remainder of the country.
Medi-Fare Drug is located in South Carolina, which is not in the Fifth Circuit, and Medi-Fare Drug was not a plaintiff in the Fifth Circuit suit. By basing its claim that individually identified patients prescriptions are required partly on FDAMA, the FDA is applying FDAMA requirements to a pharmacy that is not located in the district where it is the law.

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1 comment:

Anonymous said...

The FDA also found many issues with the sterile compounding at Medi-Fare. This pharmacy was using expired products in some of their compounds. The pharmacist was sending out medication before getting results back from their secondary testing firm. There were several other concerns the FDA discovered within the clearoom. The actually report can be found on the Internet. It's terrible after what happened at the New England Compounding Pharmacy that this facility and pharmacist in charge and owner Pat Stephens would show such negligence.