Warning Letters: Alternative Health and Patient First

March 31, 2005
Pharmaceutical Technology

Warning Letters: Alternative Health and Patient First


The US Food and Drug Administration (Rockville, MD, www.fda.gov) this week posted two new currentgood manufacturing practice (CGMP) Warning Letters issued in mid-March.

On March 17, FDA's Seattle District Office (Bothell, WA) warnedAlternative Health & Herb Remedies (Corvallis, OR, www.healthherbs.com) thatseveral of its herbal ophthalmic formulations failed to comply withCGMP requirements. The six-page letter alleges that the claims andlabeling on some of the company's tinctures (squaw vine, parsleyherb, European mistletoe, and licorice root) make them drugs within themeaning of the Federal Food, Drug and Cosmetic Act.

The agency cited Alternative Health for 15 purported CGMPviolations, including failure to establish microbial controlprocedures, failure to clean and sterilize containers, inadequatesterilization control systems, faulty record-keeping, failure toperform release testing, and inadequate review of product labels.

On March 15, FDA's Baltimore (MD) District Office warnedPatient First Corporation (Glen Allen, VA, www.patientfirst.com), aprimary- and urgent-care provider that repackages drugs, that itsoperation should better isolate its antibiotic (penicillin andcephalosporin) processing areas from other human-drug-handling areasand improve procedures for cleaning its equipment and stability-testingits products.

–Douglas McCormick