US Food and Drug Administration (FDA) has issued a guidance on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act. The guidance is intended for outsourcing facilities that compound human drugs. Now the outsourcing facilities may elect to register with FDA under section 503B.
If an outsourcing facility registers, it must report to FDA information about the drugs compounded at the outsourcing facility. This guidance focuses on electronic submission of drug reporting information.
The Drugs Quality and Security Act (DQSA) adds new section 503B to the FD&C Act. Under section 503B(b), a compounder may elect to become an outsourcing facility by registering with FDA. Upon initially registering as an outsourcing facility, and twice each year which is once in June and once in December, an outsourcer that registers with FDA must submit to the Agency a report identifying the drugs compounded by the facility during the previous six-month period. For each identified drug, the outsourcing facility must provide certain information listed in section 503B(b).
An outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act by meeting the requirements described in the rest of section 503B. Outsourcing facilities will be inspected by FDA and must comply with other provisions of the FD&C Act, such as current good manufacturing practice (cGMP) requirements.
This guidance addresses the provisions in the DQSA regarding the drug reporting requirements for registered outsourcing facilities. A separate guidance provides instructions on how outsourcing facilities should register with FDA. This guidance provides instructions for interim reporting until FDA can modify its electronic submission system to accept the electronic reports 55 for drugs compounded by outsourcing facilities. When FDA has modified its current electronic system, we will issue a new outsourcing facility product reporting guidance describing the updated format for long-term use, stated the regulatory authority.
Under section 503B each registrant must submit a product report to FDA. This report must identify all drugs compounded by the outsourcing facility during the previous six-month period and provide information on each drug. This includes: active ingredient and strength of active ingredient per unit, source of the active ingredient, the National Drug Code (NDC) number of the source drug or bulk active ingredient, if available. The regulatory also insists information on the dosage form and route of administration, package description, number of individual units produced; and NDC number of the final product, if assigned.
FDA encourages companies wishing to compound as outsourcing facilities to register with it immediately. If a facility registers before June 2, 2014, FDA does not intend to immediately enforce the requirement to report product information at the time of initial registration, as long as the facility submits its report within two months after the date of that initial registration.
Section 503B(b)(3) of the FD&C Act requires outsourcing facilities to submit drug reporting information by electronic means unless the regulator grants a request for a waiver of such requirement.