Federal Regulations For Prescribing A Scheduled Controlled Substance

It is essential that prescribing clinicians understand the federal regulations that address administering, prescribing, and dispensing scheduled controlled substances whether they treat patients in a medical office, a hospital, a long-term care facility, or a hospice setting. This knowledge is necessary not only to reduce diversion and misuse of controlled substances, but also to protect the clinician's ability to provide care while following state and federal regulations in prescribing a controlled substance. It may be equally important for clinicians to have sufficient comfort with their knowledge that they do not invariably err on the side of caution and thereby provide inadequate care (1,40).

The government's role regarding controlled substances is determined by dual imperatives and the central principle of balance. One mandate is to establish a system of controls to prevent misuse and diversion of controlled substances. The second mandate is to ensure availability of controlled substances for medical and scientific purposes and for these medications to be accessible to all who legitimately need them (52).

The clinician must comply with both federal and state regulations that govern prescribing scheduled controlled substances (53). When federal law or regulations differ from state law or regulation, the more stringent rule would apply. Therefore, if there is a question about prescribing a controlled substances, the clinician should call his or her state medical board.

One regulation governing the prescription of a controlled substance is that a lawful prescription must be issued for a legitimate medical purpose by an individual acting in the usual course of his/her professional practice (21 CFR 1306.04). The clinician may administer, prescribe, or dispense a Schedule II controlled substance to a person with intractable pain, in which no relief or cure is possible or none has been found after a reasonable effort (21 CFR 1306.07). A chronic pain patient certainly falls into this classification.

The clinician may treat acute/chronic pain with a Schedule II controlled substances in a recovering narcotic-addicted patient (21 CFR 1306.07). Federal law or regulations do not restrict the prescribing, dispensing, or administering of a narcotic medication to a narcotic-addicted patient for the purpose of alleviating pain, if such prescribing is medically appropriate within standards set by the medical community

However, one must keep good records to document that the clinician is treating a pain syndrome, not the disease of narcotic addiction (opioid maintenance or detoxification). If the clinician is going to administer or dispense directly (but not prescribe), a Schedule II narcotic drug to a narcotic-dependent person for detoxification or maintenance treatment, the clinician must have a separate registration with the DEA as a NTP (21 CFR 1306.07).

DEA does not impose any limitations on a physician or authorized hospital staff to administer or dispense but not prescribe narcotic drugs in a hospital to maintain or detoxify a narcotic-dependent person as an incidental adjunct to medical or surgical treatment of conditions other than addiction (21 CFR 1306.07).

The clinician must never postdate a prescription for a Schedule II controlled substances such as an opioid. The prescription must be signed and dated usually in the upper right-hand corner on the day written. The regulation states the prescriptions for controlled substances shall be dated as of, and signed on, the date issued (21 CFR 1306.05) (40).

DATA 2000 for office-based opioid treatment with buprenorphine (Suboxone/Subutex) is a major step forward for more widespread treatment of the disease of opioid addiction. Bupre-norphine with or without naloxone (in the form of Subutex® or Suboxone®) can be prescribed by certified and specially trained physicians. The physician must apply for and receive a waiver from the requirement to register as an NTP from the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration. However, one can prescribe buprenorphine in any form, off label for pain management without the above waiver (40).

Therefore, federal regulations in the United States are clear that the clinician can prescribe a Schedule II medication such as an opioid to a patient without the disease of addiction, in recovery from the disease of addiction, and even with an active addiction as long as the medical record documents the Schedule II medication such as an opioid is prescribed for pain, not for the disease of addiction.

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