Continued Access to Compounded Medicines Critical to Health, Safety of Americans

MIDLAND, Texas – United States District Judge Robert Junell issued a landmark ruling yesterday, holding that state-compliant pharmacists that compound drugs on the order of a valid prescription do not create “new drugs” or “new animal drugs” requiring prior FDA approval. The Court’s ruling went further than an earlier oral ruling in the case, as the Court ruled that compliant pharmacies may also compound drugs from legal bulk drug ingredients for pet and companion animals, a position the FDA vehemently opposed.

The ruling arose from a lawsuit filed by ten compounding pharmacies seeking declaratory relief regarding the FDA’s ability to regulate compounded preparations. The Plaintiffs were represented by Terry L. Scarborough and Matthew T. Slimp of the Austin, Texas law firm of Hance, Scarborough, Wright, Woodward & Weisbart.

“Taken to the FDA’s admitted conclusion, the addition of cherry flavoring to a drug to make it palatable for a child, or mixing a patient-specific i.v. therapy, would have been criminal conduct if the FDA had prevailed. This result would have been utterly intolerable in the medical community and a disaster for American patients and the physicians who serve them,” Mr. Scarborough said.

Judge Junell agreed.

“If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval,” Judge Junell wrote. “It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner.”

The Court also ruled that the FDA’s inspections are limited in a state-compliant pharmacy and refused to allow the FDA to enforce sections of an FDA Compliance Policy Guide that were inconsistent with his Order.

Compounding pharmacists prepare customized medications for patients pursuant to a doctor’s prescription when manufactured pharmaceutical products are inappropriate. FDA regulates pharmaceutical manufacturers, while compounding pharmacies are licensed and regulated by the boards of pharmacy of states in which they operate.

The case is Medical Center Pharmacy, et al. v. Gonzales, et al., No. MO-04-CV-130, in the United States District Court for the Western District of Texas, Midland-Odessa Division.

Source: International Academy of Compounding Pharmacists (IACP)

IACP was not a plaintiff in the case but filed Amicus Curiae briefs supporting them. IACP's March 2005 brief can be downloaded directly from http://www.iacprx.org/midlandamicus and its May 2006 brief from http://www.iacprx.org/midlandamicus2. About IACP The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs. Visit http://www.iacprx.org/ to learn more about pharmacy compounding.

Resources:

Midland District Court Order (.pdf)