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WHO Set to Consider Dextromethorphan Scheduling in April 2009
May 13, 2008Dextromethorphan is an important ingredient in many cough/cold medications. The World Health Organization (“WHO”) is considering whether to schedule dextromethorphan as a controlled substance under the international conventions of the United Nations system. If that occurs, then the U.S. government will be obligated to schedule dextromethorphan under the Controlled Substances Act, an action that could dramatically affect the manufacturing, distribution, and availability of medicines containing the substance.
At the next meeting of WHO’s Expert Committee on Drug Dependence, dextromethorphan is scheduled to be given a “pre-review.” That meeting will occur in April, 2009. If, following this “pre-review,” the drug is recommended for “critical review,” the committee will at the meeting thereafter determine whether to recommend scheduling.
Space does not permit a full description of the WHO scheduling process. If this issue is of interest, please call Jim Phelps or John Gilbert at Hyman, Phelps & McNamara, P.C. Also, please see our previous post, which, among other things, provides some background information on the WHO scheduling process.
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- Update on CDER, CBER, and CDRH Meetings with Industry June 9, 2023
- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement June 8, 2023
- An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking June 7, 2023
- AMCP Format for Formulary Submissions Revision – Comment Period Now Open! June 5, 2023
- CCP Improvements Allow Industry to Track Pre-submissions June 5, 2023
- 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