Drugs

Compounding Facility Insanitary Conditions Guidance Out

FDA has published a draft guidance, Insanitary Conditions at Compounding Facilities, to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. The document says it also is intended to assist state regulators in understanding some examples of what the agency considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health.

Drugs are considered under the Federal Food, Drug, and Cosmetic Act to be adulterated if they are “prepared, packed, or held under insanitary conditions whereby [they] have been contaminated with filth, or whereby [they] may have been rendered injurious to health.” The guidance says that while compounded human drug products can qualify for exemptions from some provisions of the law, there are no exemptions from requirements that drugs not be adulterated.

“Any drug that is produced under insanitary conditions is adulterated under the act, including compounded human and animal drugs, repackaged drug products, compounded or repackaged radiopharmaceuticals, and mixed, diluted, or repackaged biological products,” the document says.

The policies described in the guidance specifically address pharmacies, federal facilities, physicians’ offices (including veterinarians), and outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals), or that mix, dilute, or repackage biological products.

The guidance includes examples of insanitary conditions, information on identifying insanitary conditions, corrective actions, and regulatory action.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome