What Are The Requirements For Prescribing, Dispensing and Importing Drugs?

Question: What Are The Requirements For Prescribing, Dispensing and Importing Drugs?

Answer: Only practitioners acting in the usual course of their professional practice may prescribe controlled substances. These practitioners must be registered with DEA and licensed to prescribe controlled substances by the State(s) in which they operate.

Pharmacies filling prescriptions for controlled substances must also be registered with DEA and licensed to dispense controlled substances by the State(s) in which they operate. A prescription not issued in the usual course of professional practice or not for legitimate and authorized research is not considered valid.

Both the practitioner and the pharmacy have a responsibility to ensure that only legitimate prescriptions are written and filled.

More:

• Pharmacists must receive written and manually signed prescriptions for Schedule II substances.
• They may receive oral or faxed prescriptions for Schedule III-V substances provided they confirm the legitimacy of the prescription and the practitioner.
• Prescriptions for Schedule II controlled substances may not be refilled.
• Prescriptions for Schedule III-V controlled substances may be authorized to be refilled five times, but no prescription may be filled or refilled more than six months after the date on which the prescription was issued.
• Only those people who are registered with DEA as importers and who are in compliance with DEA requirements may have controlled substances shipped into the customs territory or jurisdiction of the U.S. from a foreign country.

DEA regulations covering prescriptions can be found in Title 21 of the Code of Federal Regulations, part 1306; rules on importers are found in 21 CFR 1312.

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