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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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