Compounder Warned for Mixing Unapproved Drugs, GMP Violations
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities.
The company was warned for its defiant response to an August 2013 inspection of its Randolph, N.J., facility, according to the warning letter posted online. Among the problems found at the plant, Pharmacy Creations was making drugs without a prescription — a common finding among larger compounding pharmacies.
The agency was further dismayed that Pharmacy Creations was compounding domperidone drug products, despite prior agency warnings in 2006 and 2008.
Domperidone is sometimes used in anti-vomiting treatments, but it is not approved by the FDA due to potential health risks.
FDA investigators also noted several quality violations. For example, the company produces sterile injectable drugs in multiple-dose containers without a preservative, which could increase the risk of infections, the June 23 letter says.
Pharmacy Creations did not test samples of drugs for strength, purity and quality and failed to test each batch to determine if it was sterile or pyrogen-free. Both of these are repeat violations from a 2006 warning letter, the agency said.
The letter recommends that the pharmacy conduct a comprehensive assessment of its quality system and hire a third-party consultant to help.
Pharmacy Creations responded to an August 2013 Form 483 by saying that it abides by U.S. Pharmacopeia (USP) regulations.
This is an oft-cited defense among compounders to agency inspection findings, signaling that such facilities are pushing back against being evaluated based on FDA regulations.
Medaus made the same response when it was warned by the agency earlier this year for unsanitary processing procedures. The Birmingham, Ala., pharmacy was hit with a warning letter for technicians performing aseptic processing with exposed skin, but the facility responded its procedures meet USP regulations.
Compounders have also complained that the agency is retroactively applying the 2013 Drug Quality and Security Act, which gave the FDA new authority to oversee compounding pharmacies.
The agency cited the law when it warned Pharmacy Creations, even though the inspection took place several months before the law was finalized in November. Pharmacy Creations is the eleventh compounder to receive a warning letter since passage of DQSA.
Per the new law, the agency issued guidance establishing an interim good manufacturing practice framework for large compounders that register with the FDA and finalized guidance on the enforcement of smaller, traditional compounders.
Pharmacy Creations is developing a response to the letter, Susan Brichler Trujillo, an attorney for the compounder said.
The company wants the FDA to immediately close out the matter “due to actions Pharmacy Creations has taken in the 10 months since the August 2013 inspection,” Trujillo said.
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