Pharmacies

Compounding Pharmacies were well represented in this week’s digest of Recently Posted Warning Letters.  Four of the nine letters posted were associated with compound pharmacies.

All 4 of the warning letters identified the pharmacies failed to receive valid prescriptions for individually identified patients. As we know, compounding without a valid individual prescription does not meet the conditions of 503A.  Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA.

Specific observations identified by the FDA in the posted warning letters include (listed in numerical order of the CFR):

  • 21 CFR 211.28(a) Inappropriate clothing worn to protect the drug product from contamination Cited 1
  • 21 CFR 211.42(b): Inadequate design of the facility to prevent contamination or mix-ups Cited 1
  • 21 CFR 211.42(c)(10(iv): Failed to establish a system to monitor environmental conditions in the aseptic processing area Cited 2
  • 21 CFR 411.42(c)(10)(v): Failed to establish a system for cleaning and disinfecting the room and equipment to produce aseptic conditions) Cited 2
  • 21 CFR 211.42 (c)(10)(vi): Failure to establish a system for maintaining equipment used to control the aseptic conditions Cited 1
  • 21 CFR 211.67(a): Failed to sanitize and/or sterilize equipment and utensils Cited 1
  • 21 CFR 211.113(b): Failed to establish and follow procedures to minimize microbiological contamination Cited 2
  • 21 CFR 211.165(a): Failure to test each batch to verify the drug product meets final specifications prior to release Cited 2
  • 21 CFR 211.165(f): Failed to reject drug product that did not meet established standards or specifications, or any other relevant quality control criteria Cited 1
  • 21 CFR 211.166(a): No Stability testing program Cited 1
  • 21 CFR 211.167(a): Failure to test each batch to verify the drug product meets final specifications for sterility and/or pyrogen Cited 1
  • 21 CFR 211.192: Failed to investigate any unexplained discrepancy Cited 1

The warning letters are available on the FDA website.  A link to each warning letter is provided below:

Please note that there is approximately a year or more between the facility inspection and posting of the warning letter.  The warning letter identified the conditions that were observed during the inspection and may not represent current conditions.