This bill aims to modernize the communication of drug prescribing information by amending the Federal Food, Drug, and Cosmetic Act. It permits manufacturers to make required prescribing information for certain drugs available solely by electronic means , streamlining the dissemination process. However, a crucial provision ensures that manufacturers must still offer prescribers and dispensers the opportunity to elect to continue receiving all such information in paper form, or to request paper labeling on an as-needed basis. Any requested paper information must be provided promptly and without additional cost , maintaining accessibility for all healthcare professionals. The Secretary of Health and Human Services is directed to issue final regulations within one year to implement these changes, including clear instructions for obtaining paper copies, and to design these regulations to minimize adverse economic impacts on prescribers and dispensers. Additionally, a public workshop will be held within two years to discuss optimizing the format, accessibility, and usability of prescribing information. The new electronic provision will apply to drugs introduced into interstate commerce two years after enactment or upon the effective date of the final regulations, whichever comes first.
Prescription Information Modernization Act of 2025
USA119th CongressHR-4132| House
| Updated: 6/25/2025
This bill aims to modernize the communication of drug prescribing information by amending the Federal Food, Drug, and Cosmetic Act. It permits manufacturers to make required prescribing information for certain drugs available solely by electronic means , streamlining the dissemination process. However, a crucial provision ensures that manufacturers must still offer prescribers and dispensers the opportunity to elect to continue receiving all such information in paper form, or to request paper labeling on an as-needed basis. Any requested paper information must be provided promptly and without additional cost , maintaining accessibility for all healthcare professionals. The Secretary of Health and Human Services is directed to issue final regulations within one year to implement these changes, including clear instructions for obtaining paper copies, and to design these regulations to minimize adverse economic impacts on prescribers and dispensers. Additionally, a public workshop will be held within two years to discuss optimizing the format, accessibility, and usability of prescribing information. The new electronic provision will apply to drugs introduced into interstate commerce two years after enactment or upon the effective date of the final regulations, whichever comes first.