Compounding Pharmacy Warned Over a Variety of Violations

FDA sent a warning letter, dated August 15, 2016, to College Pharmacy, Colorado Springs, detailing violations the agency observed during inspections conducted in 2013 and 2015. The letter details a number of violations including deficiencies in sterile manufacturing and the manufacture of unlicensed biological products, misbranded drugs, and adulterated drugs.

The agency determined after two inspections that the company was producing products that violate the Federal Food, Drug, and Cosmetic Act (FDCA). FDA states that the company was not obtaining valid prescriptions for individually identified patients for some products. “During the FDA inspections, the investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce.  Accordingly, the drugs you compound without valid prescriptions for individually identified patients are not entitled to the exemptions in section 503A. In addition, we remind you that there are a number of other conditions that must be satisfied to qualify for the exemptions in section 503A of the FDCA.”

FDA also cited the company for “serious deficiencies” in sterile manufacturing practices. During a 2015 inspection, inspectors observed personnel using non-sterile cleaning wipes to apply disinfectants to the ISO 5 work surfaces, some lyophilization operations were not performed under ISO 5 conditions, and the company failed to demonstrate that hoods in ISO 5 areas where sterile products were processed provided adequate protection.  FDA determined the company failed to validate aseptic and sterilization procedures, failed to establish an adequate system for cleaning and disinfecting rooms and equipment, failed to ensure personnel were wearing appropriate gowning, and failed to “withhold components from use until the lot has been sampled, tested, examined and released by the quality control unit.”

These observations follow a 2013 inspection that found inadequately designed and maintained aseptic areas. “During the 2015 inspection, FDA investigators noted that while your firm made improvements to your aseptic processing area, objectionable conditions regarding your aseptic processing operations remain,” FDA stated in the letter.

Because of these violations, the agency determined that the company’s products were adulterated. “FDA investigators observed that drug products, including biological products, in your facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing them to be adulterated under section 501(a)(2)(A) of the FDCA,” the letter stated.

FDA also determined that the company was manufacturing and marketing allergenic products, which are considered biological products under the Public Health Service Act (PHS Act). The company also used unlicensed materials in the manufacture of certain allergenic products. “Although section 503A of the FDCA provides an exemption for certain compounded drugs from the requirement to obtain premarket approval under section 505 of the FDCA, it does not provide an exemption from the requirement to obtain premarket approval under section 351 of the PHS Act.  Thus, for purposes of section 503A, a “drug” does not include any biological product that is subject to licensure under section 351 of the PHS Act. Accordingly, such biological products are not eligible for the exemptions for compounded drugs under section 503A of the FDCA,” FDA stated.

In the letter, FDA stated that some of the company’s responses to the FDA 483 citations “appear adequate” but did not address all issues. The company’s responses did not clarify use of sterile wipes in ISO 5 work areas, failed to provide information on corrections to lyophilization operations, did not include documentation on smoke studies, and did not explain the lack of proper gowning practices. FDA further pointed out that the company did not commit to identifying all microorganisms recovered during environmental monitoring.

FDA recommended the company perform a comprehensive assessment of its operations, especially aseptic processing. The agency also recommended the hiring of a third-party consultant with sterile drug manufacturing experience.

Source: FDA