Drugs

Multiple Issues at Professional Compounding Pharmacy

David McFarland

— 3 min read
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A 12/10/18-1/28/19 FDA inspection at Professional Compounding Pharmacy (Health Solutions Pharmacy Center), Corvallis, OR, found that the drug products produced by the pharmacy failed to meet conditions for exemption from certain provisions of the Federal Food, Drug, and Cosmetic Act. A just-released 3/31 Warning Letter says the investigators noted serious deficiencies in the pharmacy’s practices for producing sterile drug products, which puts patients at risk. The letter notes that the firm no longer produces drugs for human use and is producing only animal drugs. Specific violations were: 

  •          failing to adequately maintain facilities and equipment necessary for the aseptic production of sterile drug products;
  •          using [redacted] beakers, spatulas, and stirring bars to mix raw materials and components of sterile drug products;
  •          using inadequate cleaning procedures;
  •          failing to perform adequate [redacted] studies under dynamic conditions to demonstrate unidirectional airflow within the ISO5 area;
  •          failing to perform media fill studies;
  •          using deficient personnel gowning and aseptic procedures;
  •          using non-sterile [redacted] and non-sterile wipes to disinfect components, including vials, rubber stoppers, and filters when transferring them from the ISO7 area top the ISO5 area;
  •          using non-pharmaceutical grade water as a component of non-sterile drug products and non-pharmaceutical grade alcohol as a component of sterile drug products;
  •          the ISO5 workstation surface appears to be constructed of a material that is porous and not easily cleanable.

The letter also lists these current good manufacturing practice violations: 

  •          failing to perform operations within specifically defined areas of adequate size and to have separate or defined areas or other control systems necessary to prevent contamination in aseptic processing areas;
  •          failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements;
  •          failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
  •          failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic sterilization processes;
  •          failing to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality;
  •          failing to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance with such specifications; and
  •          failing to have a written testing program designed to assess the stability characteristics of drug products to be used in determining storage conditions and expiration dates.

The letter says the products not eligible for the compounding exemption are misbranded because they are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and thus adequate directions for use cannot be written so that a layperson could use the products safely for their intended use.

FDA acknowledged the firm’s 8/6/19 statement that it intended to cease the production of sterile drug products for human and animal use and to cease production of non-sterile drug products for human use. “If you decide to resume operations, you must correct all insanitary conditions at your firm,” the agency said.

The company is now operating as Pet Pharmacy NW, the agency says, under the license number previously held by Professional Compounding Pharmacy. It compounds only non-sterile veterinary drug products.

The firm was told to respond with a list of any specific steps taken to correct the violations or with a statement that it does not intend to resume the production of human drugs. If it does intend to resume the production of human drugs, it must explain each step being taken to prevent the recurrence of the violations and related documentation.

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