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FDA Reschedules Hydrocodone to Schedule II Controlled Substance

FDA Reschedules Hydrocodone to Schedule II Controlled Substance

The FDA's reclassification of Hydrocodone to a Schedule II controlled substance takes effect on October 6, 2014. This will put medications such as Vicodin, Lortab and their generics in the same class as medications containing codeine and oxycodone.

While this has been debated for more than a decade, the FDA took action last year. The final rule was posted to the Federal Register on 22 August 2014, and may be viewed at
The summary reads: "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. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. 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."

The previous Schedule III class had made hydrocodone-containing medications easier to prescribe, fill and refill, as they were subject to fewer controls than Schedule II substances. (Previously, it could legally be refilled up to 5 times before the patient had to see the provider again.) This ease of prescribing may help explain why it is the most-prescribed prescription pain-killer with $2.5 billion in sales last year (see Medscape's list at ). As a schedule II substance, hydrocodone-containing medications may now only be prescribed for the equivalent of 90 days of dosing (inclusive of refills). See

While this move will not bar Physician Assistants from prescribing medications containing hydrocodone, it may limit those prescriptions in some cases.

The Navy's guidance for prescribed and filling scheduled substances at Military Treatment Facilities is provided in the Manual Of Medical Department Chapter 21. There, 22.5 states that "Authority for physician assistants and nurse practitioners to prescribe Schedule II through V controlled substances may be granted by the CO, if within their scope of practice and designated in their privileging documents." 50.9.b goes on to state "Physician assistants ... may prescribe and administer only those controlled substances listed in the activity's authorized medical allowance list (AMAL)."

Physician Assistants working at Department of Veterans Affairs facilities will face additional restrictions. (For example, Navy Physician Assistants currently work at the James A. Lovell Federal Health Care Center -- the first joint VA-DoD hospital located in North Chicago, Illinois.) In the VA system, the authority for Nurse Practitioners, Physician Assistants and Pharmacists to prescribe schedule II medications varies by the providers' state of licensure (not state of practice). Information on each State's requirements can be found at:
16 states currently do not allow civilian PAs to prescribe Schedule II medications.


Ari Doucette

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