- Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry? December 10, 2019
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FDA Signals Issuance of Its Recommendation To DEA To Move Hydrocodone Combo Products to Schedule II
October 24, 2013By Delia A. Stubbs –
While typically not made public, today, FDA issued a statement that it intends to forward a recommendation to DEA by December to move hydrocodone combination products from their current placement in Schedule III to Schedule II. That change would mean, among other things, stricter security controls on those drugs as well as a restriction on the amount of medication – 90 days worth – that a patient can be prescribed at one time.
FDA’s recommendation comes as no surprise, given its advisory committee’s recommendation earlier this year that it reach this result (see our previous post here). CDER Director, Janet Woodcock, projected that the regulations re-scheduling hydrocodone “could take effect as early as next year.”
The development is interesting given pending legislation that would accomplish the same result, but would afford a grace period to certain DEA registrants, namely manufacturers and distributors and other “non-practitioners,” to comply with the new storage and security requirements (see our previous post here).
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- Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry? December 10, 2019
- Court Decides FDA Can’t Regulate Device as Drug December 9, 2019
- Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin December 5, 2019
- HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger December 4, 2019
- FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020 December 3, 2019
- 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
- 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