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Final Rule to reclassify Hydrocodone Combination Products takes effect Oct. 6

The Final Rule that moves hydrocodone combination products (HCPs) from Schedule III to the more restrictive Schedule II under the Controlled Substances Act (CSA) takes effect Oct. 6. HCPs are pharmaceuticals that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin.

To assist physicians in complying with the new regulations, the AMA developed this fact sheet. Key points include:

  • Prescriptions for HCPs issued on or after Oct. 6 must comply with requirements for Schedule II prescriptions. Refills of these prescriptions will be prohibited.
  • Prescriptions for HCPs issued before Oct. 6 that have authorized refills may be dispensed in accordance with DEA rules for refilling, partial filling, transferring, and central filling Schedule III-V controlled substances until April 8, 2015. However, certain pharmacy systems, state laws and other factors may not allow remaining refills to be dispensed once the rule is in effect.

 
More information is available on the AMA website and in this Sept. 4 Medigram story.

Back to September 25, 2014 Medigram