FDA Finalizes Guidance On Unsanitary Conditions At Compounding Pharmacies

Federal regulators are calling for compounding pharmacies to improve cleanliness at their facilities in newly released recommendations intended to prevent illnesses and outbreaks.

The final guidance was issued November 6, highlighting the Food and Drug Administration’s (FDA) ongoing effort to address unsanitary conditions at compounding pharmacies. The guidance also details corrective actions the facilities should take when these conditions are identified.

Compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drug products. However, the drugs are not reviewed by the agency for safety, effectiveness or quality before being given to consumers.

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The long-awaited guidance includes recommendations for tools and techniques compounding pharmacies should use to develop appropriate controls for preventing unsanitary conditions at their facilities, which the FDA says would prevent the spread of unsafe medications or illness.

The statement also addresses regulatory actions the FDA may take when compounding pharmacies are found to operate under unsanitary conditions.

In recent years, compounding drugs have been a source of major illness outbreaks among patients across the United States. In 2012, a compounding pharmacy in Massachusetts was the source of a multi-state fungal meningitis outbreak which led to thousands of illnesses and dozens of deaths. The outbreak stemmed from tainted compounded steroid injections.

Drug quality continues to be a problem for compounding pharmacies. A recent Institute for Safe Medication Practices survey indicated nearly 75% of compounding pharmacies had at least one dispensing error occurring at their pharmacy in the past year.

“Under federal law a drug is considered adulterated if it is prepared, packed, or held under unsanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health,” according to FDA standards.

FDA investigations of compounding pharmacies have uncovered poor conditions which can affect drug quality and potentially harm patients. Federal investigators have found dirt, mold, insects, trash, peeling paint, unclean exhaust vents and dirty high-efficiency particulate air filters (HEPA).

Some compounding pharmacies have voluntarily issued drug recalls or halted manufacturing due to improper conditions discovered by FDA inspectors. However, some have continued to operate despite such findings, which the agency says could put patients at risk.

“Through our oversight and regulatory actions, we address insanitary conditions at compounders’ facilities across the country,” wrote the FDA. “We will continue to take appropriate action to protect patients from poor quality drugs made in facilities that have insanitary conditions.”

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