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Compounding pharmacies get low marks in FDA test. (10 of 29 Prescriptions Fail Assays).
SAN FRANCISCO -- Ten of 29 prescriptions obtained in a Food and Drug Administration survey of compounding pharmacies failed assays, Vaiyapuri Subramaniam, Pharm.D., reported at the annual meeting of the American College of Clinical Pharmacology.
Of the 10 failed samples, 9 were significantly subpotent and 1 contained unacceptable levels of endotoxin.
The take-home message is, "Professionals and patients beware," Dr. Subramaniam, a Food and Drug Administration compliance officer, told this newspaper. "There are risks involved."
Compounding is defined as combining, mixing, or altering ingredients by a licensed pharmacist to create a customized drug for a patient based on the receipt of a valid prescription.
The FDA survey included compounds for oral use, for ophthalmic use, for injection, for inhalation, and for pellet implants. The drugs that failed potency assays were injectable betamethasone, hyaluronidase, papaverine, and progesterone; ophthalmic ciprofloxacin, dexamethasone, and timolol maleate; and oral progesterone. A sample of injectable alprostadil contained high levels of endotoxin.
The FDA recruited patients with legitimate prescriptions and had the prescriptions compounded at 12 pharmacies selected based on their prominence on the Internet. The 29 ...