Update on Compounding Pharmacies

In the title above is a link to another Boston Globe article today reporting on the decision by US District Judge Robert Junell (5th Circuit, W.D. Texas) on the case between the FDA and several compounding pharmacists over whether the FDA has jurisdiction to regulate the specialty drugs created in compounding pharmacies as a new medicine.

... FDA enforcement agents overstepped the agency's jurisdiction by attempting to inspect the records of pharmacists in good standing with state regulators. Legislation passed by Congress that exempts compounding pharmacies from such detailed FDA inspections ``demonstrates Congress's intent to carve out a niche for compounded drugs," he (Judge Junell) said.

The ruling said that unless pharmacies disobey local laws or dispense compounded drugs without a doctor's prescription written for an individual patient, the FDA can only conduct ``limited" inspections of such items as equipment, materials, and labels.

From the Globe.



See this helpful Link from the American Association of Physicians and Surgeons for press releases, and full text of the complaint, briefs and motions in the case. I expect they will have the decision posted soon.

See also Pharmalive, a website for the pharmaceutical industry, which summarizes the decision:

The case -- 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 -- was filed in September 2004 by 10 pharmacies against the Food and Drug Administration and addressed a number of issues affecting the practice of pharmacy compounding.

First, the Court ruled that "compounded drugs do not fall under the new drug definitions" and, as a result, are legal. Judge Junell explained: "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 ... 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."

Second, the Court ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless FDA can demonstrate that the pharmacy is not compliant with applicable state laws and does not operate as a retail pharmacy. The Court also ruled that each of the 10 plaintiffs met the requirements for exemption.

Third, the Court ruled that compounding from bulk pharmaceutical ingredients for non-food animals is legal. This is an important issue for animal owners and their veterinarians who prescribe compounded medications to treat a variety of conditions, many of which require medications that are only available by compounding bulk pharmaceutical ingredients. Without them, animals may needlessly suffer or even die. Until now, FDA asserted that prescribing and preparing these treatments was illegal.

Also helpful, TPA, the Texas Pharmacy Association website.

And of interest if you are researching the issue, This link to a communication from Senator Charles Grassley of Iowa to the FDA and the Centers for Medicare-Medicaid Services. The letter outlines information regarding the misuse of compounded drugs, and is dated July 13, 2006.