Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › PRESCRIPTIONS › Section 25.57 - Nonprescription orders

Current through Register Vol. 54, No. 28, July 13, 2024
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 issued under section 5(a) of
						  the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §
														960.5).
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).