Policies for Outsourcing Facilities

Posted 10 December 2018 | By Ana Mulero 

FDA Redrafts GMP Policies for Outsourcing Facilities
The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback.

The draft guidance aims to clarify provisions that became applicable to outsourcing facilities, following the 2013 enactment of section 503B under the FD&C Act that allowed drug compounders to register as outsourcing facilities with FDA. Outsourcing facilities must be GMP compliant and are subject to FDA site inspections, though they can quality to be exempt from the agency’s premarket approval requirements.

FDA has flagged noncompliance via Form 483s issued after inspections from 2016 through 2018 at most of the 77 outsourcing facilities that are currently registered. These include seven 483s escalated to FDA warning letters in which inspectional observations became significant GMP violations in 2017 and 2018.

The agency “continues to find concerning conditions and practices that can lead to contaminated, super or sub-potent, or mislabeled products” and this has been “especially true” among compounders that are not adhering to GMP requirements, said FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram. This finding underscored the need for the proposed draft guidance.

Outsourcing facilities can refer to the redrafted guidance document to demonstrate compliance with FDA’s policies on GMP requirements in 21 CFR parts 210 and 211 “until final regulations are issued,” the agency said. From facility designs to laboratory controls and complaint handling, the new draft guidance reflects changes across all GMP sections compared to the 28-page interim guidance document from 2014. These include new subsections entitled “additional considerations for sterile drug products.”

Revisions are also intended to address hindered “office stock” provided by outsourcing facilities that commenters reported, citing the 2014 interim policies. “We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality,” Gottlieb and Abram added. Thus, the revised guidance “includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testing, and beyond-use dating.”

The policies—coupled with guidance FDA finalized in May for clarifications around the term outsourcing facility—seek to make it easier for compounding pharmacies to become outsourcing facilities as well.

A public meeting was set for May to discuss the potential industry impact and two new entries were added to FDA’s list of drug products that cannot be compounded as part of the new efforts in the sector.

The agency also intends to “define what substances can be used in compounded products by traditional compounders” and issue a final rule to identify criteria applied to its list of bulk drug substances that may be used in compounding under section 503A sometime in the near future, according to Gottlieb and Abram. Outlining “new compounding priorities” is on the agency’s agenda for 2019 as well.

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act: Draft Guidance