The following is a 2017 Compounding Pharmacy Update.
Compounding Pharmacies continue to be in the spotlight at FDA. A review of posted warning letters by USFDA identify the following frequency of occurrence through early June for each of the past 4-years:
The 4 year average January 1 to ~June 4 is ~15 warning letters. With 14 warning letters issued to compounding pharmacies issued thus far in 2017, industry performance seems comparable to the past 4 years. Will this trend continue for the rest of the year? Will the FDA change the level of oversight based on congressional intervention?
Nine of the 14 warning letters contained specific cGMP deficiencies and the top 5 findings included:
21 CFR 211.28(a), 5 findings: The firm failed to ensure that manufacturing personnel wore clothing appropriate to protect drug product from contamination.
21 CFR 211.113(b), 4 findings: The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
21 CFR 211.167(a), 4 findings: The firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product.
21 CFR 211.42(c)(10)(v), 4 findings: The firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.42(c)(10)(iv), 3 findings: The firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
With 2017 nearly half gone, will the 2017 compounding pharmacy performance improve, remain the same, or worsen when compared to the historical averages?