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New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities

Posted 03 August 2016 | By Michael Mezher 

New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.

The safety of compounded drugs has been a high profile issue for FDA since 64 people were killed by a fungal meningitis outbreak tied to the New England Compounding Center, a Massachusetts-based compounder, in 2012. Since then, both Congress and FDA have taken steps to improve the safety of compounded drugs.

FDA has also issued hundreds of Form 483s and more than 100 warning letters to compounders over issues uncovered during inspections. Additionally, FDA says it has "identified insanitary conditions at many of the compounding facilities that it has inspected," which has led to a number of compounders recalling products and ceasing sterile operations.


Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. These exemptions allow compounders operating under section 503A of the act to produce drugs without complying with current good manufacturing practice (cGMP) and certain labeling requirements, and sell those drugs without marketing approval from FDA.

In response to the 2012 meningitis outbreak, Congress passed the Drug Quality and Security Act (DQSA) which amended the FD&C Act to clarify requirements for compounders and created a pathway for compounders to register with FDA as outsourcing facilities.

Under the DQSA, registered outsourcing facilities operating under section 503B of the FD&C Act must follow cGMP requirements and are required to report adverse events to FDA for the drugs they produce in order to maintain exemptions for labeling and approval requirements.

Draft Guidance

Despite the exemptions, compounders are still required to abide by section 501(a)(2)(A) of the FD&C Act, which states that a drug is adulterated "if it has been prepared, packaged, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health."

However, because most compounders are not registered with FDA as outsourcing facilities, they are not routinely inspected by the agency unless it becomes aware of a problem with a specific product or compounder.

"It is critical that compounding facilities avoid the presence of insanitary conditions and identify and remediate any insanitary conditions at their facilities before the conditions result in drug contamination and patient injury," FDA writes.

As such, FDA's new guidance includes examples of insanitary conditions that its inspectors have observed during past inspections, such as the presence of vermin, visible microbial contamination and non-microbial contamination such as rust or hair in a production area.

The guidance also details procedures compounders can put in place to ensure their facilities are sanitary and actions they can take when insanitary conditions are found.

According to FDA, the new guidance is intended to apply to a wide array of products, including:

  • compounded human and animal drugs;
  • repackaged drug products;
  • compounded or repackaged radiopharmaceuticals; and
  • mixed, diluted, or repackaged biological products

And will apply to:

  • Pharmacies
  • Federal facilities
  • Physicians' officers (including veterinarians' offices)
  • Outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals) or that mix, dilute or repackage biological products



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