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The District of Columbia Proposes Pharmaceutical Detailer Regulations
July 2, 2008On 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.
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- Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices May 7, 2024
- DEA Concurs: Marijuana Meets Schedule III Criteria May 6, 2024
- The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?) May 3, 2024
- Sarah Wicks Returns to HPM to Elevate Drug Development and Regulatory Practice May 2, 2024
- FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction May 1, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized