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FDA Seeks Comments on Compounding Guide

Donna Young

Just one week after releasing a document to help pharmacists legally compound drugs, FDA said it eagerly awaits comments on the agency’s new compliance policy guide, developed in response to a May ruling by the Supreme Court.

The regulatory agency has not set a cutoff date for receipt of comments, said FDA policy officials who declined to be identified for this article or respond to specific questions about the guide. Health-system pharmacists are invited to help FDA "fine-tune" the pharmacy compounding guide and "understand what needs to be clarified" for pharmacists who work in the health-system environment.

The guide lists nine actions that will likely prompt FDA to initiate action against a pharmacy or health system:

  1. Compounding drug products in anticipation of receiving prescriptions, except in very limited quantities relative to the amount of drugs compounded after receiving valid prescriptions;
  2. Compounding drugs that were withdrawn or removed from the market for safety reasons (the guide’s Appendix A lists such drugs; this will be updated, as appropriate);
  3. Compounding finished drug products from bulk active ingredients that are not components of FDA-approved drugs and not the subject of an FDA-sanctioned investigational new drug application;
  4. Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot has been made in an FDA-registered facility;
  5. Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements;
  6. Using commercial-scale manufacturing or testing equipment when compounding drug products;
  7. Compounding drug products for third parties that resell to individual patients, or offering compounded drug products at wholesale to other state-licensed persons or commercial entities for resale;
  8. Compounding drug products that are commercially available in the marketplace or are essentially copies of commercially available FDA-approved drug products (when a pharmacist compounds a small quantity of a drug product that differs only slightly from an FDA-approved product, the agency will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient); and
  9. Failing to conform with applicable state laws regulating the practice of pharmacy.

FDA may consider other factors in a particular case, according to the agency’s guide.

Because the guide is in its "very early stages," the officials said, health-system pharmacists who have specific questions are strongly urged to call the agency.

The federal agency will continue to defer instances of "less significant violations" in pharmacy compounding to state authorities.

Until the guide is final, the officials said, health-system pharmacies that are found to have violated any of the nine factors would more than likely receive a warning letter from FDA with clarification on how to correct the problem.