§ 16.94. Labeling of dispensed drugs.

 (a)  The label on a dispensed drug container shall include the name of the drug, using abbreviations if necessary; the quantity; and the name of the manufacturer if the drug is a generic drug. If a practitioner specifically indicates that the name of the drug may not appear on the label, the recognized national drug code number shall be placed on the label if the number is available for the product. The label shall also bear the name and address of the practitioner, the date dispensed, the name of the patient and the directions for use of the drug by the patient.

 (b)  Drugs which, at the time of their dispensing, have full potency for less than 1 year, as determined by the expiration date placed on the original label by the manufacturer, may only be dispensed with a label that indicates the expiration date. The label shall include the statement, ‘‘Do not use after manufacturer’s expiration date,’’ or similar wording.

Cross References

   This section cited in 34 Pa. Code §  501.5 (relating to exemptions); 49 Pa. Code §  18.6a (relating to prescribing, dispensing and administering drugs); and 49 Pa. Code §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).



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