According to Section 502 of the Federal Food, Drug, and Cosmetic Act, "A drug or device shall be deemed to be misbranded—if its labeling is false or misleading in any particular." Some examples of false labeling are incorrect, inadequate, or incomplete identification of a medical product.
Below are eight keys you can use to tailor your operation to prevent false labeling:
1. Vendor specifications—The specifications provide details for the vendor to produce accurate labeling that has been approved by the Food and Drug Administration (FDA).
2. Accuracy examination—At the time you receive the labels, those labels must be verified for accuracy based on the specification.
3. QA release—The acceptance and the release of the labeling after the examination must be documented (before application to a package material).
4. Identification in storage—Again, before application, the labeling should be identified appropriately, with restricted access to the storage area.
5. Line clearance—Prior to starting the labeling operation, the equipment should be cleared of all materials from the previous operation.
6. Label issuance—The label materials must be verified against the batch documentation prior to label application.
7. In-process verification—Personnel or equipment can be used to verify label correctness.
8. Label reconciliation—After labeling is completed, the use of the labeling needs to be calculated and differences justified.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
