Section 25.57. Nonprescription orders

A controlled substance listed in Schedules III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § § 301—392, may be dispensed without a prescription to a purchaser at retail provided that the following conditions are met:

(1) Such distribution is made only by a registered pharmacist and not by a nonpharmacist employe even if under the direct supervision of a pharmacist; although, after the pharmacist has fulfilled his professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist.

(2) Not more than 240 milliliters, eight fluid or avoirdupois ounces of any such controlled substance listed in Schedule V containing opium nor more than 120 milliliters, four fluid or avoirdupois ounces of any other controlled substance listed in Schedule V may be distributed at retail to the same purchaser in a given 72-hour period, except under a written or oral prescription of a licensed practitioner in possession of a DEA number.

(3) The purchaser is at least 18 years of age.

(4) The pharmacist requires every purchaser of a controlled substance listed in Schedule V not known to him to furnish suitable identification, including proof of age where appropriate.

(5) A bound record book for distributions of controlled substances, other than by prescription order, is maintained by the pharmacist. This book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the dispensing pharmacist.

(6) No individual other than a registered manufacturer, distributor, practitioner, or pharmacy in possession of a Federal DEA registration shall acquire or attempt to acquire controlled substances containing opium listed in Schedule V in excess of eight fluid or avoirdupois ounces nor any other controlled substance if listed in Schedule V in excess of four fluid or avoirdupois ounces for any individual in a 72-hour period, except when dispensed pursuant to a prescription or prescription order.

The provisions of this § 25.57 adopted June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.

Notation

Authority

The provisions of this § 25.57 issued under section 5(a) of the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. § 960.5).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relating to prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing and dispensing drugs); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); and 49 Pa. Code § 25.177 (relating to prescribing drugs, pharmaceutical aids and devices).