FDA Obtains Consent Decree of Permanent Injunction Against Drug Repackager For Alleged CGMP and Labeling Violations
There are a number of issues worth highlighting in this case:
- FDA takes the distribution of mislabeled drugs seriously, and the agency is willing to initiate an enforcement action if a company fails to take adequate corrective actions. As Howard Sklamberg—Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research—said in regards to this case, “[m]islabeled drugs pose a serious risk to patients who rely on labeling to know what they are taking . . . . These potential risks include overdose, dangerous interactions with other drugs, unnecessary exposure to toxicity, and potential side effects.”
- FDA expects a facility that only engages in the repackaging and labeling of drug products to fully comply with the applicable CGMP regulations. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a drug is adulterated if it is not manufactured, processed, packed, or held in conformance with CGMP. See 21 USC 351(a)(2)(B). FDA has clarified in its CGMP regulations that the manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations. See 21 CFR 210.3(b)(12).
- The cessation of operations is not a defense to an FDA enforcement action. In this instance, Shamrock’s representatives informed the court that they are no longer repackaging or distributing any drugs. Nevertheless, the government pursued and obtained the injunction against Shamrock. The Consent Decree specifically contemplates Shamrock’s cessation of operations and details the steps that must be taken if Shamrock decides to resume operations. For example, Shamrock must first notify FDA of its intentions to resume operations, and Shamrock will not be able to resume operations until they receive written notice from the FDA that their operations comply with the Consent Decree and the FDCA.
The government’s Complaint and Consent Decree are available at the following links:
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