Tag Archives: pharmacies

FDA’s Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.

Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the Food, Drug, and Cosmetic Act (FD&C Act) prohibited drug facilities from denying FDA: (1) entry or the opportunity for inspection or; (2) refusing access to or the opportunity to copy specific records. Section 707 of the FDASIA extends this prohibition, through section 501(j) of the FD&C Act, by deeming a drug adulterated if ” … it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” This provision extends to “any factory, warehouse, or establishment in which … drugs … are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such … drugs … in interstate commerce.” FDASIA also adds section 704(a)(4) to the FD&C Act, allowing FDA to “request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or information that FDA may inspect under section 704(a).”

To read the full text of this Alert, please visit the Duane Morris website.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include: