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CPG Sec. 460.425 Prescription Status when Telephoned to Recording Machine October 1980

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research


Under Section 503(b) of the Act the dispensing of a prescription drug contrary to a written or oral prescription of a physician is an act which results in the drug being misbranded while held for sale. In some cases a physician may telephone the prescription to a pharmacists' recording machine and questions have arisen as to whether this procedure constitutes an acceptable "oral prescription" under the Act.


The 503(b) requirement is complied with if the pharmacist dispenses a prescription drug as ordered by the physician. The FDA considers a recorded prescription as meeting the requirements of an "oral prescription," as allowed by Section 503(b), if the pharmacist plays back the recording and concludes that the voice he or she hears is that of a physician known to the pharmacist, and there is no obvious reason for suspecting the authenticity of the recorded prescription.

Issued: 10/1/80

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