On June 27, 2008, the District of Columbia Department of Health proposed regulations to implement Title 1 of the SafeRx Amendment Act of 2008 (“SafeRx Act”), which FDA Law Blog previously reported on in January 2008. Under the proposed regulations, pharmaceutical detailers in the District would need to be licensed by the Board of Pharmacy by April 1, 2009. The Board would begin accepting applications for licensure on October 1, 2008.
The proposed regulations outline:
- A pharmaceutical detailer code of ethics, including mandatory compliance with the PhRMA Code on Interactions with Healthcare Professionals to the extent that the PhRMA Code does not conflict with the SafeRx Act or its implementing regulations;
- The license application process and fees;
- Education requirements for licensure and the educational requirement waiver process;
- Continuing education requirements and approval of continuing education programs;
- The authority of the Board of Pharmacy to collect information from licensed detailers; and
- Detailer record retention requirements.
Comments on the Proposed Rule are due by July 27, 2008.
An article that appeared in the June 2008 issue of RAPS Focus describes the relevant provisions of the SafeRx Act.