Hydrocodone Combination Products Now Controlled Substances
August 25, 2014 – The Drug Enforcement Agency (DEA) announced that effective October 6, 2014, hydrocodone combination products will be rescheduled from schedule III to schedule II controlled substances. According to the Controlled Substance Act, schedule II drugs are considered to have a high potential for abuse and dependency and are recognized for their medical benefit.
Schedule II medications are subject to more strict dispensing guidelines and regulation, therefore, Hydrocodone Combination Products are not eligible for refills, may only be allowed to be filled within 30 days from the date the prescription was written (may vary by state) and are not allowed to be prescribed electronically, the hard copy prescriptions must be presented to the pharmacist.
According to IMS Health, hydrocodone combination products, including popular drugs like Vicodin®, Lortab®, and their generic equivalents, were the most widely prescribed drugs in 2012 with more than 125 million prescription filled.
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Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.