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# West Coast Nuclear Pharmacy Compounding Issues
- URL: https://www.fdaweb.com/west-coast-nuclear-pharmacy-compounding-issues/
- Published: 2020-12-02T12:00:00.000Z
- Updated: 2026-09-14T16:38:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148205

A 3/19/18-3/23/18 FDA inspection at West Coast Nuclear Pharmacy, Tampa, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A just-released 10/6 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/west-coast-nuclear-pharmacy-604169-10062020?ref=fdaweb.com) says that under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities, and radiopharmaceuticals that are repackaged, are subject to all provisions of the Federal Food, Drug, and Cosmetic Act related to the production of drugs, including provisions related to insanitary conditions.

The letter says the agency investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, possibly contaminating them with filth or rendering them injurious to health, thus causing the products to be adulterated under the law.

FDA says it strongly recommends that the pharmacy management undertake a comprehensive assessment of operations including facility design, procedures, personnel, processes, maintenance, materials, and systems. It says such a review should particularly focus on aseptic processing operations. And it recommends that the firm retain a third-party consultant with relevant sterile drug manufacturing experience to assist it in the comprehensive evaluation.

West Coast was told to submit a list of specific steps it has taken to correct the violations and prevent their recurrence, with related documentation and a schedule for completing the corrections.