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# Drug Compounding Issues at The Medicine Shoppe
- URL: https://www.fdaweb.com/drug-compounding-issues-at-the-medicine-shoppe/
- Published: 2021-10-06T12:00:00.000Z
- Updated: 2026-09-14T17:18:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150310

FDA says its 3/9-3/16/20 inspection at Walter Corp., doing business as The Medicine Shoppe, Port Charlotte, FL, found that drugs the company produces failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, a 9/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walfer-corporation-dba-medicine-shoppe-pharmacy-611017-09172021?ref=fdaweb.com) says, the investigators noted serious deficiencies in the firm’s practices that put patients at risk.

The letter says the investigators noted that The Medicine Shoppe did not receive valid prescriptions for individually-identified patients for a portion of the drug products it produces.

The investigators also found that the company’s drug products were prepared, packed, or held under insanitary conditions, whereby they have become contaminated with filth or rendered injurious to health, the letter says.

The inspection also found significant current good manufacturing practice regulation violations, including: 

- failing to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin; and
- 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.

FDA says the firm’s ineligible compounded drug products also are misbranded.

The letter acknowledges that The Medicine Shoppe recalled all drugs within expiry and says that some of the company’s proposed corrective actions appear to be adequate while others can’t be fully evaluated because the company did not provide sufficient information or supporting documentation.

The Medicine Shoppe was told to take prompt action to correct the violations and to respond with an indication of whether it has taken any specific steps to correct the violations.

FDA acknowledges that the company said it had ceased production of sterile drugs and said that if it plans to resume production of sterile drugs it should explain each step being taken to provide sterility assurance considering, in particular, the conditions that contributed to the recall of sterile drugs, and copies of related documentation.