Gottlieb Supports Compounded Drugs

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The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

On Sept. 26, 2017, FDA Commissioner Scott Gottlieb, MD, made a statement regarding the agency’s efforts to ensure available and safe compounded drugs. The agency is continuing its commitment to oversee drug compounders and is providing resources to these companies in the hopes of promoting safer products.

Compounded drugs, while not approved by FDA, provide therapies to healthcare providers and patients that might not otherwise be available. These medications, however, come with the potential for contamination if improperly manufactured. “Supporting access to compounded drugs made under high production standards involves helping new outsourcing facilities as they strive to develop expertise in compounding medicines under current good manufacturing practice standards,” Gottlieb said in the statement.

Facilities registered with FDA under section 503B of the Food, Drug, and Cosmetics Act are regulated by FDA and must comply with current good manufacturing practices. In the past few years, FDA has increased their effort to inspect these facilities, resulting in a variety of warning letters issued by the agency.

The Drug Quality and Security Act (DQSA), enacted in November 2013, directs FDA to identify and trace prescription drugs in the United States. The agency is also required to establish national licensure standards for wholesale distributors and third-party logistics providers. These companies must annually report licensure information to FDA. “We are committed to realizing DQSA’s framework for facilities that register as outsourcing facilities, and are working on a number of efforts specific to this growing sector as it works to meet these regulatory standards and fulfill its intended role in the continuum of care for patients,” said Gottlieb.

FDA is making an effort to implement DQSA, give patients access to compounded drugs, and protect the health of the public. As part of the effort, it has made public a list of drugs produced by companies registered as outsourcing facilities. “We are making the list public, among other reasons, to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards,” Gottlieb said.


The agency also published a

for outsourcing facilities and met with state partners regarding drug compounding. The guide will help compounders to decide if they need to register with FDA and provide a resource on policies and procedures.

“We’ll be taking additional steps in the coming months to help more compounders register as outsourcing facilities-by continuing to streamline the process and appropriately calibrate the regulatory burden of operating as an outsourcing facility,” Gottlieb stated. “Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process.”

Source: FDA