• Changes to drug medication guides. FDA’s proposed rule will amend FDA medication guide regulations to require a new form of patient labeling, namely, Patient Medication Information, for submission to and review by FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The rule will include requirements for the development and distribution of Patient Medication Information and will require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.
• Direct-to-consumer prescription drug advertisements. FDA plans to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Prescription drug advertisements presented through media such as television and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement that in DTC television or radio advertisements for human prescription drugs stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications of the advertised drug must be presented in a clear, conspicuous, and neutral manner.

In addition, HHS highlighted a series of long-term action priorities for FDA, including FDA’s plans to create National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers. FDA intends to craft a final rule establishing national standards for state licensing of prescription drug wholesale distributors and third-party logistics providers. FDA will also establish a federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a state licensure program.

Finally, in addition to the proposed rulemaking, FDA’s Center for Drug Evaluation and Research (CDER) recently issued its guidance agenda, which identifies new, revised and immediately-in-effect guidances planned for publication in 2024. Among those listed are the following guidance documents that may have an impact on pharmacy practice:

• A revised draft of FDA’s January 2018 Guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act;
• A revised draft of FDA’s January 2018 Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act;
• A revised draft of FDA’s July 2014 Guidance on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act;
• Guidance regarding Nominations of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; and
• Guidance regarding Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors – Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act.

Reed Smith will continue to monitor FDA’s progress on the above initiatives over the coming year. In the meantime, should you have any questions regarding the above, please do not hesitate to reach out to any of the authors on this alert for further discussion.

Client Alert 2024-038