SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act.
812 ); initially codified in DEA regulations at 21 CFR 308.12(b)(1)(x) (36 FR 7776, April 24, 1971) (currently codified at 21 CFR 1308.12 (b)(1)(vi)). Pub. 1236, sec. 1236, sec. Hydrocodone was listed in schedule II of the CSA upon the enactment of the CSA in 1971. 91-513, 84 Stat. Public Law 91-513, 84 Stat. 812); initially codified at 21 CFR 308.13(e) (3) and (4) (36 FR 7776, April 24, 1971) (currently codified at 21 CFR 1308.13 (e)(1) (iii) and (iv)).\3\ Any other hydrocodone single-entity products or combinations of hydrocodone with other substances outside the range of specified doses are listed in schedule II of the CSA.\4\.
When the Controlled Substances Act was enacted in 1971, drugs containing hydrocodone as the only active ingredient were listed on Schedule II, signifying a high potential for abuse, while HCPs were placed on the less restrictive Schedule III. Notably, prescriptions for Schedule II drugs cannot by refilled.
Then, on October 6 2014, following a notice of proposed rulemaking, which drew 573 comments, DEA rescheduled HCPs from Schedule III to Schedule II.
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On Oct. 6, the DEA will move hydrocodone combination products from Schedule III to Schedule II, so family physicians need to prepare their practices -- and their patients -- for the change.
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But the rescheduling of HCPs to Schedule II will change this, he said.
After scrutinizing the DEA regulation, Prescriber's Letter recently issued recommendations (preview.hs-sites.com) to help physicians prepare for the Oct. Among key points covered are the following:. 6 rescheduling implementation date.
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Prescriber's Letter also is offering a patient handout (cdn2.hubspot.net) to help patients better understand how these changes affect them.
"I had complete pain relief with this anti-inflammatory," he said.
Patients who use drugs containing hydrocodone as a pain reliever or cough suppressant are going to have to jump through more hoops to get them starting next month. The Drug Enforcement Administration is reclassifying so-called "hydrocodone combination products" from Schedule III to Schedule II.
Vicodin, for example, is an HCP because it has hydrocodone and acetaminophen. The Drug Enforcement Administration is reclassifying so-called "hydrocodone combination products" from Schedule III to Schedule II under the Controlled Substances Act, which will more tightly restrict access.
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Adding insult to injury, they may get dinged with an office visit charge for their new prescription. "All of these patients are going to find out they don't have a valid prescription, and have to go in and get a new one," Fleury says.
"We're hearing that because of discrepancies in state law, payers may not want to authorize refills," says Stacie Maass, a senior vice president at the American Pharmacists Association.
DEA today published a final rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II, effective October 6, 2014. APhA and most pharmacy groups strongly opposed the move.
The pharmacy groups also noted that rescheduling HCPs will add costs for patients as well as to the health care system. “Pharmacies and distributors will have to comply with stricter storage and handling laws for Schedule II controlled substances, and such requirements may cause delays in maintaining an adequate supply of HCPs.
Other concerns include the short amount of time to implement the new requirements, including updating ordering systems with the new NDC numbers and more stringent Schedule II record-keeping and storage requirements, according to Michael H Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.