FDA Announces More Compounding Pharmacy Recalls
FDA inspections reveal possible inaccurate sterility testing.
FDA inspections of compounding pharmacies have revealed that results of some sterility testing by third-party laboratories may be inaccurate, causing potential risk to patients. University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level. The recall is a result of FDA inspections of methods used by an independent third-party laboratory to assess sterility. FDA believes the sterility test results may not be reliable and there may be microbial contamination in products intended to be sterile.
Last week, FDA announced a voluntary recall of products from Medaus Pharmacy, including sterile compounded consumer products, due to inability to confirm that the quality control testing performed by an independent, third-party laboratory was conducted in a manner consistent with standards.
Source: FDA.gov
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
