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Hydrocodone Combination Products Rescheduled from Schedule III to Schedule II effective October 6, 2

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration rescheduled hydrocodone combination products (HCP) from schedule III to schedule II of the Controlled Substances Act. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.

In addition to pharmacists and distributors who are familiar with the handling of Schedule II substances, this change will also impact other providers of health care, especially long term care facilities. This action significantly limits the pain management drugs available in Schedule III that are needed by an elderly population with both malignant and non-malignant pain. Now, a nursing home resident whose pain has been adequately controlled by the use of HCPs which can be ordered and refilled monthly, will need to have a physcian's order each month. This means more physicians visits and higher health care costs. The Administrators response is that long term care facilities are "unique potential sources of diversion" because controlled substances accumulate in an unregistered, relatively unsecure environment.


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