Current through Register Vol. 54, No. 44, November 2, 2024
(a) A pharmacy
shall maintain a supply of drugs and devices adequate to meet the needs of the
health professions and the patients it is intended to serve. The applicant for
a pharmacy permit shall show proof by affidavit that the applicant has ordered
or possesses and shall continue to maintain an inventory of nonproprietary
drugs, devices and equipment appropriate to the practice of that pharmacy. The
inventory must include at least $5,000 worth of nonproprietary drugs and
devices, at cost, from a licensed wholesaler or manufacturer. The inventory may
not go below this figure at any time. A central processing center is not
required to maintain $5,000 worth of nonproprietary drugs and devices under
§
27.203(b)
(relating to centralized prescription processing).
(b) Drugs which must be removed from active
stock shall be removed in accordance with the following provisions:
(1) The pharmacist manager is responsible for
removing from the active stock of the pharmacy and disposing of the following:
(i) A drug whose expiration date has
passed.
(ii) A drug which does not
meet legal standards of strength and purity.
(iii) A drug which varies from the strength
and purity indicated on the label of the commercial container.
(iv) A drug which has been improperly
stored.
(v) A drug which has
deteriorated.
(vi) A drug which is
unfit, misbranded or adulterated under Federal or State statutes.
(2) Drugs which have been removed
from active stock in accordance with this subsection may not be sold or given
away. The drugs shall be returned to the wholesaler or manufacturer for
disposal or disposed of by the pharmacy according to Federal or State statutes
or regulations.
(3) A pharmacy
desiring to or required to dispose of a controlled substance shall contact the
nearest DEA office for authority and instructions to dispose of the
substance.
(4) The pharmacist
manager shall be responsible for keeping proper records of controlled
substances which have been disposed of. These records must include the name of
the substance, the number of units or the volume of the substance or the number
of commercial containers and the date and manner of disposal.
(c) Except for a pharmacy
operating as a central processing center, a pharmacy shall maintain at least
the following equipment and supplies:
(1) A
refrigerator, used solely for the storage of drugs requiring refrigeration,
equipped with a thermometer or a temperature monitoring device. The
refrigerator shall be kept in the prescription area.
(2) Prescription files for keeping
prescriptions of nonproprietary drugs in accordance with the act and, for
controlled substance prescriptions, State and Federal laws and regulations. The
original prescription or image of the original prescription shall be retained
for 2 years from the date of the most recent filling. A pharmacy may make use
of a computerized recordkeeping system for keeping track of telephone
prescriptions, refills, counseling, and the like in accordance with §
27.202 (relating to computerized
recordkeeping systems).
(3) Current
copies of the act and this chapter.
(4) Federal and Commonwealth statutes and
regulations pertaining to the practice of pharmacy.
(5) Additional equipment and supplies
necessary to enable the pharmacy to properly prepare and dispense prescriptions
consistent with its scope of practice.
(6) An adequate reference library which meets
the following standards:
(i) Enables a
pharmacy to prepare and dispense prescriptions properly, consistent with its
scope of practice.
(ii) Includes
reference sources appropriate to the type of pharmacy practice at that
particular location. A pharmacy shall include in the pharmacy's library current
material regarding the technical, clinical and professional aspects of practice
with emphasis in the area in which the pharmacy specializes.
(iii) Enables the pharmacist to compound
medications in a safe and effective manner consistent with accepted standards
of pharmacy practice.
(iv) Lists
the possible drug interactions and possible adverse effects of medications
dispensed by the pharmacy.
(v)
Lists the therapeutic equivalents for medications.
(vi) Lists the therapeutic usage and dosages
of medications dispensed by the pharmacy.
(vii) Provides guidelines for the counseling
of patients.
(viii) A pharmacy that
specializes in nuclear or parenteral prescriptions may limit the library it
maintains under subparagraph (ii) relating to the pharmacy's own
specialization.
(ix) Maintains the
latest editions including current supplements of each of its reference
sources.
(d) A
pharmacy operating as a central processing center shall maintain equipment,
supplies and access to a reference library recognized by the pharmacy community
in this Commonwealth as meeting minimum standards of practice as a central
processing center.
The provisions of this §27.14 amended under
sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S.
§§
390-4(j) and
390-6(k)(1) and (9)); amended
under sections 4(j) and 6(k)(1) of the Pharmacy Act (63 P. S. §§
390-(4)(j) and 309-6(k)(1)).
This section cited in 6 Pa. Code §22.62 (relating
to conditions of provider participation); 28 Pa. Code §113.12 (relating to
supplies); 28 Pa. Code §561.12 (relating to supplies); and 49 Pa. Code
§
43b.7 (relating to schedule of
civil penalties-pharmacists and
pharmacies).
