The FDA’s draft guidance, released in July, recognizes the differences between outsourcing facilities and commercial drug manufacturers and looks to tailor the cGMP (current good manufacturing practice) requirements to the unique needs of the compounding industry.
However, both BIO and GPhA call on the FDA to make a distinction within cGMP requirements between (a) sterile drug products that are compounded by the aseptic combination of licensed, commercially manufactured sterile drug products under aseptic conditions (sterile-to-sterile [S-S]) and (b) sterile drug products that are compounded from non-sterile bulk active pharmaceutical ingredients(API) “since the risks associated with the compounded drug product differs between these two types of products, necessitating different controls.”
Same Criteria
Both industry groups also call for a somewhat level playing field for compounders and other drug manufacturers.
GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.”
Similarly, BIO disagrees with FDA’s proposed alternative approaches for reducing the need for laboratory testing of incoming components and to minimize the need for facilities to have an in-house laboratory.
“We believe that the alternative approach to testing should not be permitted exclusively for outsourcing facilities,” BIO says. “These sites should be accountable for maintaining the same level of control over their contract sites as would any other pharmaceutical manufacturer.”
And while outsourcing facilities may contract release testing to an outside laboratory, BIO believes “that they should be required to comply with the same requirements and expectations as would need to be met by a pharmaceutical manufacturer. It is important that FDA apply the same well established and standard industry requirements to ensure adequate and consistent protection of public health.”
BIO also makes note that outsourcing facilities “are not exempt from the obligations that manufacturers of biological products must satisfy,” and the group “recommends that the Agency clearly state that this Guidance only applies to small molecule products that are approved under the Federal Food, Drug and Cosmetic Act (FFDCA) and not to biological products approved under the Public Health Service Act (PHSA).”
Pharmacists
Unlike BIO and GPhA, ASHP (Association of Health-System Pharmacists), however, is largely supportive of FDA’s moves to relieve the compounding industry from burdensome new regulations. It says it “supports the FDA’s alternative approach to minimize the need for facilities to have an in-house laboratory. Having testing performed by a third party registered with the FDA would improve confidence in the accuracy of the testing procedures and results. Having a uniform set of standards for laboratories to meet under this approach would also have the added benefit of consistency across end-product testing standards.”
ASHP also says it “supports the FDA’s various conditions place on outsourcing facilities to verify the identity and integrity of incoming components used in compounding.”