Federal Court Rules Compounders Are Exempt from FDA Regulation

September 7, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

US District Court Judge Robert Junell issued a written opinion in Medical Center Pharmacy, et al. v. Gonzalez, et al., supporting the ten plaintiff pharmacies? assertion that the US Food and Drug Administration lacks the authority to regulate compounded drugs and inspect state-licensed retail pharmacies.

Missouri City, TX (Aug. 30)-US District Court Judge Robert Junell issued a written opinion [see here] in Medical Center Pharmacy, et al. v. Gonzalez, et al., supporting the ten plaintiff pharmacies’ assertion that the US Food and Drug Administration (Rockville, MD, www.fda.gov) lacks the authority to regulate compounded drugs and inspect state-licensed retail pharmacies. The opinion followed Junell’s May 25, 2006 ruling from the bench.

Junell held that compounded drugs do not fit FDA’s definition of new drugs and said that the cost and time involved in the new-drug approval process would prevent patients from obtaining individually tailored prescriptions. “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,” Junell wrote.

The opinion also says that FDA may not inspect a pharmacy’s records unless the agency can show that the pharmacy does not comply with relevant state laws and does not operate as a retail pharmacy. Junell also ruled that all plaintiffs in the case met the requirements for exemption.

The ten Texas pharmacies filed the case in September 2004 in the US District Court for the Western District of Texas, Midland-Odessa Division (see “Compounding Pharmacies’ Lawsuit Against FDA Will Continue,” ePT, May 27, 2005, http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=163587&searchString=compounding).

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