Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections.
One warning letter dated March 23 accused Winchester, Va.-based Wellness Pharmacy of improperly compounding without individual patient prescriptions, misbranding and adulteration. Another compounding pharmacy — Custom Compounding Center in Little Rock, Ark. — was accused of the same violations plus the production of unapproved drugs.
The FDA’s Baltimore District Office accused Wellness Pharmacy of “serious deficiencies” in its production of sterile products. The letter was prompted by an inspection in March 2015.
The letter, which was posted online, cites a host of GMP violations, including inadequate systems for maintaining equipment to ensure cleanliness, a lack of written procedures to prevent contamination of sterile drug products, failure to establish adequate controls for disinfecting equipment, insufficient environmental monitoring and employees’ failing to wear protective clothing when producing sterile compounds.
Additionally, the letter contends that because the company is purportedly compounding medications without patient prescriptions, it doesn’t qualify for federal exemptions on GMP and labeling requirements, rendering its products misbranded. According to the letter, the drugs it compounds are for conditions not amenable to self-diagnosis and treatment, rendering them inadequate for patients to safely use.
Second Verse, Same as the First
Custom Compounding’s citation made many of the same allegations, with the complaints coming from the agency’s Dallas District office. The March 16 letter cited the company for “serious deficiencies” with its sterile compound production.
The agency accused Custom Compounding of five GMP violations, three of which — inadequate systems for maintaining equipment to ensure cleanliness, insufficient environmental monitoring and employees’ failing to wear protective clothing when producing sterile compounds — mirror those in Wellness Pharmacy’s letter. The other two concern the company’s failure to establish and follow a testing program to assess the stability characteristics of drug products and ensuring that all employees are properly trained and experienced, according to the letter.
Where the letters part ways is on an allegation of unapproved new drug production, which the agency leveled because the drugs being compounded without prescriptions are not FDA approved.
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