Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug reporting requirements for those entities registered as outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act (FFDCA).

Congress amended the FFDCA in November 2013 to add Section 503B, which distinguishes between compounders engaged in filling patient-specific prescriptions and those compounding larger volumes of drugs without individual prescriptions. By registering with the FDA and complying with the statute’s requirements, Section 503B outsourcing facilities are exempt from certain provisions of the FFDCA, including new drug approval requirements and the requirement to label drugs with adequate directions for use.

The three newly issued guidance documents include two final guidance documents and one revised draft guidance. Because the statute is relatively new, any guidance issued by the FDA may be particularly valuable to those operating as outsourcing facilities or considering registering as a 503B entity.

Registration

The final guidance, titled Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, provides greater clarification on certain issues discussed in the interim guidance released December 2013. The final guidance includes information on how a registered 503B outsourcing facility can de-register, clarifies what registration information will be made public and the standard for receiving a waiver from the electronic submission requirements. It also specifies that a 503B outsourcing facility may be licensed as a pharmacy and may obtain prescriptions for individual patients. The final guidance also provides a phone number for a point of contact at the FDA.

Required Fees

The FDA’s final guidance on fees, titled Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, confirms many of the matters detailed in the FDA’s March 2014 draft guidance. The final guidance clarifies which entities qualify for a small business fee reduction and that the FDA may request additional information from those seeking the fee reduction. It otherwise includes minor revisions to requirements concerning re-inspection fees, the effect of failing to pay fees in a timely manner and refunds and dispute resolution.

Electronic Drug Product Reporting Requirements

The FDA’s revised draft guidance, titled Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act, explains how 503B outsourcing facilities must submit drug reports. Section 503B of the FFDCA requires that outsourcing facilities report to the FDA information about the drugs compounded at the facility. The revised draft guidance details entities that must report, what information must be provided and the manner such reports must be submitted using the FDA’s electronic submissions system structured product labeling (SPL) format. It supersedes the FDA’s initial draft guidance issued December 2013.

The revised draft guidance clarifies the time period during which a facility must submit product reports, as well as information concerning the strength of the active ingredient per unit, package description and number of individual units produced. It includes a reference to detailed instruction on how to submit information using SPL, as well as clarification that reports submitted are exempt from inspection unless the Secretary of the U.S. Department of Health and Human Services finds that an exception would be inconsistent with the protection of the public health.

Until the revised draft guidance is finalized, the FDA will accept drug reports that comply with the initial draft guidance. However, the FDA “strongly encourages” 503B facilities to submit drug reports in accordance with the guidelines in the revised draft guidance.