FDA warns compounding pharmacy of wood contamination
- Wood doesn't mix well with drug products, or so the Food and Drug Administration was forced to dryly caution in a warning letter sent to ImprimisRX Pharmacy over adulterated products flagged in a 2016 inspection.
- In the visit to ImprimisRx's Pennsylvania site, investigators from the regulator raised concerns about unsanitary conditions and the potential for cross-contamination during compounding of beta-lactam products.
- Samples from one lot collected by the inspectors found "fibrous material consistent with wood" in some of the tested product.
Following the inspections last summer, ImprimisRX informed the FDA in November that it would stop producing formulations with powdered penicillin or related beta-lactam active pharmaceutical ingredients. That commitment appears to have placated the FDA, which noted in the recent warning letter that the firm's actions "adequately" addressed its concerns.
The regulator will, however, verify the production halt in a follow-up inspection and recommended ImprimisRx undertake a comprehensive review of its operations.
ImprimisRx is a wholly owned subsidiary of Imprimis Pharmaceuticals Inc. — best known for introducing a $1 compounded version of Daraprim (pyrimethamine) in the midst of the controversy sparked by Martin Shkreli's decision to raise the drug's price by 5,000%.
Imprimis Pharmaceuticals, though, is no longer the owner of the Folcroft facility, having sold the site to Creative Pharmacy Solutions Central, LLC as part of a $450,000 deal to divest its sinus business. Announced in June, the sale closed July 17.
"This was an important step for the company as it should help reduce non-strategic overhead expenses and again allow us to further focus resources on our strongest asset in upcoming launches which live within ophthalmology," explained Imprimis CEO Mark Baum on an August 5 call with investors.
Other manufacturing headaches may persist, however. The FDA has investigated two severe adverse events, including one death, associated with the use of curcumin emulsion product compounded by ImprimisRx in Irvine, California.
ImprimisRx has recalled all unexpired products containing ungraded PEG 40 castor oil, which was flagged by the FDA as a potential risk.
"It is important to clarify that we believe these unfortunate events occurred due to allergic or hypersensitivity reactions to a product these patients likely should never have been administered," Imprimis' Baum said in a statement on the adverse events. "We have safely dispensed the referenced curcumin emulsion over 30,000 times without incident."
- FDA Warning letter
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