FDA will continue to enforce the pharmacy compounding provisions of the FDA Modernization Act until the Supreme Court rules on a lower court decision that the compounding section is invalid.

The agency said it will enforce the pharmacy compounding section of FDAMA outside the Ninth Circuit, where the provision was successfully challenged in Tommy Thompson v. Western States Medical Center, et al.

"During the time that the appeal is pending, it is FDA's position that Sec. 503A is valid outside of the Ninth Circuit," FDA said in an Oct. 10 warning letter to Temple, Tex.-based Unique Pharmaceuticals, which "purports to be a compounding pharmacy."

The warning letter says the drugs prepared by the company "do not qualify for exemptions" to new drug, adulteration and misbranding provisions of the FD&C Act.

"Your products are not being prepared for identified, individual patients based on prescription orders from licensed practitioners within an established relationship," FDA told the company.

"Instead, they have been distributed to wholesale drug distributors for further sale to hospitals, pharmacies and physicians, which goes beyond the regular course of selling or dispensing drugs at retail." FDA added that Unique Pharmaceuticals manufactures "drugs appearing to be copies of commercially available drug products."

The company produced large quantities of copies of 10 commercially available drugs, including nearly 40,000 vials each of dexamethasone and triamcinolone over a three-month period, the letter says.

The Supreme Court agreed Oct. 29 to hear the government's appeal of Western States Medical.

The plaintiffs are challenging FDAMA's prohibition on pharmacy advertising for compounding of a particular drug as a First Amendment violation. In February, the San Francisco federal appellate court for the ninth circuit ruled that the pharmacy compounding section of FDAMA is "invalid in its entirety" (¹ Also see "Pharmacy Compounding Disclaimer May Be Alternative To FDAMA, Court Says" - Pink Sheet, 12 February, 2001., p. 29).

The National Community Pharmacists Association is one of the most vocal opponents to FDA regulation of compounding.

NCPA's incoming head, Bruce Roberts, is an advocate of compounding services. In addition to offering compounding at his Leesburg, Va. pharmacy, Roberts is on the board of the International Academy of Compounding Pharmacists and a member of U.S. Pharmacopoeia's expert advisory panel on compounding. Roberts will start at NCPA in January (² Also see "NCPA Leadership Transition: Bruce Roberts To Succeed Calvin Anthony Jan. 1" - Pink Sheet, 24 September, 2001., p. 11).

The government argued in its petition to the Supreme Court that Congress' intent in crafting the compounding provisions was to balance the need to preserve the integrity of the new drug approval process and the need to have compounded drugs available.

In considering the free speech issue, the appeals court "erroneously failed to apprehend and refused to credit the substantiality of the government's interest in balancing" the competing interests, the Department of Justice's petition says.

The court's ruling was based partly on the government's failure to provide evidence that compounding poses a public health risk, the document notes. The "evidentiary demand is particularly inappropriate in this case, because it is based on a rejection of the fundamental premise of the FD&C Act."

DoJ's petition responds to the appeals court's suggestion that alternatives exist to FDAMA's advertising restrictions.

The court's alternatives - disclaimers that compounded drugs are not FDA-approved or requiring new drug approval for compounded drugs - "would not only fail to advance, but would substantially hinder, the accomplishment of the purposes" of the law, the government said.

Reliance on disclaimers would be "fundamentally inconsistent" with the purposes of the drug approval requirements, DoJ said, and subjecting compounded drugs to the approval process "would be directly contrary to Congress' purpose of making compounded drugs available" for individual patients.

FDA Enforcing Rx Compounding Regs Pending Supreme Court Ruling

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