Section 27.14. Supplies

(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 adopted June 1, 1973, effective June 2, 1973, 3 Pa.B. 1051; amended June 14, 1991, effective June 15, 1991, 21 Pa.B. 2710; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended March 1, 2002, effective March 2, 2002, 32 Pa.B. 1194; amended May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518; amended September 5, 2008, effective September 6, 2008, 38 Pa.B. 4895. Immediately preceding text appears at serial pages (319638) to (319640).

Notation

Authority

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)).

Cross References

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).