Federal regulators have released five guidance documents intended to increase regulatory oversight of compounding pharmacies, a long awaited move taken in the wake of a 2012 fungal meningitis outbreak that was caused by contaminated compounding drugs that were shipped nationwide.
The FDA-issued draft guidance documents were issued February 13, nearly three years after a fungal meningitis outbreak linked to products compounded by the New England Compounding Center (NECC) killed more than 60 people and sickened hundreds more throughout the U.S.
The guidance documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians, focusing on outsourcing facility registration, outsourcing facility adverse event reporting, drug repackaging, mixing, diluting and repackaging biological products. The FDA said the documents were issued to help companies comply with important public health provisions.
A new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted in response to the deadly fungal meningitis outbreak and provides new laws for how compounding pharmacies should be regulated.
Drugs produced by compounders not registered as outsourcing facilities are required to meet other conditions.
The first draft document focuses on which entities should register as compounding facilities, clarifying facilities engaged in certain activities, including repackaging human drugs and compounding non-sterile drugs, should register as outsourcing facilities since those drugs will not qualify for exemptions.
The second draft guidance concerns how companies may repackage certain human drug products produced by compounding pharmacies.
The guidance explains the FDA will not take action against facilities if they follow certain rules, some of which include guidance indicating that a repackaged compounded drug must be a copy of an FDA-approved drug, it must be repackaged at a licensed facility and must be done so in a way that doesn’t “conflict with approved drug product labeling.”
The third guidance focused on repackaging biological products and details what the FDA will take action against, such as when state license pharmacy facilities mix, dilute, or repackage specific products without an approved license.
The fourth guidance concerns adverse event reporting for compounding pharmacies. It confirms compounding pharmacies are required to report the events to the FDA.
The last document is a draft memorandum of understanding detailing the responsibility of the states to investigate and respond to complaints related to compounded human drug products.
Compounding Drug Outbreak Repercussions
FDA officials issued the recent draft guidance documents to prevent outbreaks like the fungal meningitis outbreak in 2012, which health officials linked to tainted epidural steroid injections compounded by the NECC and sold to many health facilities across the country. A recall was issued by NECC after the tainted steroid were discovered, however the outbreak sickened more than 700 people.
More than 17,000 vials of the contaminated steroid were distributed to hospitals and other medical centers nationwide. More than 14,000 patients received the shot.
A $100 million settlement was reached by the owners of the NECC, its insurers and some associated medical companies. The settlement will be offered to the victim compensation fund for those who developed meningitis after receiving tainted steroid injections.
In December 2014, the Justice Department arrested 14 individuals linked to the outbreak, filing charges and seeking jail time for the executives involved.