Pennsylvania Code
Title 49 - PROFESSIONAL AND VOCATIONAL STANDARDS
Part I - DEPARTMENT OF STATE
Subpart A - PROFESSIONAL AND OCCUPATIONAL AFFAIRS
Chapter 27 - STATE BOARD OF PHARMACY
STANDARDS
Section 27.18 - Standards of practice

(a) A pharmacist shall dispense a new prescription in a new and clean container or in the manufacturer's original container. In refilling a prescription, the pharmacist may reuse the original container of that prescription if the container is clean and reuseable. The refill requires a new label containing the information specified in subsection (d). Pharmacies and pharmacists shall comply with the Poison Prevention Packaging Act of 1970 (15 U.S.C.A. §§ 1471-1476) which includes the use of child resistant containers.

(b) Prescriptions kept on file in the pharmacy must meet the following requirements:

(c) A pharmacist may decline to fill or refill a prescription if the pharmacist knows or has reason to know that it is false, fraudulent or unlawful, or that it is tendered by a patient served by a public or private third-party payor who will not reimburse the pharmacist for that prescription. A pharmacist may not knowingly fill or refill a prescription for a controlled substance or nonproprietary drug or device if the pharmacist knows or has reason to know it is for use by a person other than the one for whom the prescription was written, or will be otherwise diverted, abused or misused. In addition, a pharmacist may decline to fill or refill a prescription if, in the pharmacist's professional judgment exercised in the interest of the safety of the patient, the pharmacist believes the prescription should not be filled or refilled. The pharmacist shall explain the decision to the patient. If necessary the pharmacist shall attempt to discuss the decision with the prescriber.

(d) The container in which a prescription drug or device is sold or dispensed to the ultimate consumer shall bear a label which shall be written in ink, typed or computer generated and shall contain the following information:

(e) No pharmacist may enter into an arrangement or agreement with a nonlicensed person whereby prescription orders or prescription drugs and devices may be regularly left with, picked up from, solicited by, accepted by or delivered to the nonlicensed person or whereby a pharmacist pays or has an arrangement or agreement with the nonlicensed person to perform these functions. Nothing in this section shall prohibit a licensee from picking up a prescription or delivering a prescription drug or device, at the request of the patient, at the office or home of the prescriber or patient, at an institution in which a patient is confined, at another place as the patient designates for his safety and convenience, or by means of an employe, the mails or common carrier. Nothing in this section shall prohibit a licensee from delivering naloxone to an identified employee of a Pennsylvania correctional facility, prison, jail or residential drug treatment facility under a prescription and for an identified individual who is pending release or discharge from the correctional facility, prison, jail or residential drug treatment facility.

(f) No pharmacist or pharmacy may dispense, dispose of, or sell a Schedule V cough preparation containing codeine, dilaudid or other narcotic cough preparation without a prescription, except that this subsection does not apply to a preparation used within an institution.

(g) Sales of Schedule V narcotic preparations are required to have affixed to the bottle or container at the time of sale a label indicating the name and address of the pharmacy and the initials of the pharmacist and the date of sale.

(h) No prescription may be knowingly filled or refilled for a patient which prescription was written for prior use by a prescriber who is deceased or no longer in practice.

(i) Prescriptions for nonproprietary drugs may be refilled for 1 year from the date of the prescription if refills have been authorized by the prescriber. A nonproprietary drug which is refillable by statute on the basis of designation, such as ad lib, PRN or similar instruction, may be refilled for 1 year from the date of the prescription. Refills may be authorized at any time during the 1-year period.

(j) Prescriptions for Schedule II controlled substances may not be filled more than 6 months from the date of the prescription. Prescriptions for Schedule II controlled substances may not be refilled. A controlled substance in Schedule III, IV or V may not be filled or refilled more than five times in the 6-month period from the date of the prescription.

(k) Prepacking and labeling in convenient quantities for subsequent use shall be done under the direct personal supervision of a registered pharmacist. A container shall have a label containing the name of the drug and, if the name is generic, the name of the manufacturer, its strength, the manufacturer's control number or other code control number and the expiration date, if any. A log shall be kept in the pharmacy stating the name of the drug and, if the name is generic, the name of the manufacturer, its strength, the manufacturer's control number or other code control number, the expiration date, if any, and the date and quantity prepacked.

(l) Prescriptions sent through the mail to a pharmacy shall be compounded and dispensed in the following manner:

(m) Prescription drugs, medications and devices which are delivered shall be sent in such containers as are reasonably necessary, considering the nature of the drug, medication or device, to insure its safety and effectiveness for the patient.

(n) A prescription by means of an oral order, telephone or otherwise, shall be received and transcribed by either a registered pharmacist or a pharmacy intern under the direct, immediate and personal supervision of a pharmacist.

(o) Except as provided under the definition of order, an oral prescription shall be reduced to writing immediately by the pharmacist or pharmacy intern and shall be filled by, or under the direction of the pharmacist. An order entered on the chart or medical record of a patient in an institution for the diagnostic care and treatment of a patient on an overnight basis, or on the chart or medical record of a patient under emergency treatment in an institution by or on the order of a practitioner authorized by statute to prescribe drugs or devices, shall be considered to be a prescription if the medication is to be furnished directly to the patient for self-administration. It is the responsibility of the prescriber to see that the chart or medical record contains the information required for a prescription and that it is signed by the prescriber himself at the time the drug is given or if he is not present, then on his next visit to the institution. A registered pharmacist may not compound, prepare, dispense, fill, sell, or give away a drug or device on the basis of a prescription or order in an institution or hospital unless the prescription or order is an original prescription or order or direct copy thereof issued by the authorized prescriber or practitioner who may be using electronic or computerized equipment.

(p) The pharmacist has the responsibility to make his professional service available under the following conditions:

(q) No pharmacist, pharmacy owner or pharmacist manager may be permitted to provide a medical practitioner or a person authorized to prescribe drugs or devices with prescription blanks bearing a pharmacist's name or the name or address of the pharmacy thereon.

(r) The following provisions apply to the advertisement and sale of drugs:

(s) Sales of hypodermic needles and syringes shall be made by a pharmacist or under the direct, immediate and personal supervision of a pharmacist in accordance with the following:

(t) A pharmacist may only refill a prescription at a reasonable time prior to the time when the contents of the prescription shall be consumed according to prescriber's directions.

(u) A violation by a pharmacist of the Federal Controlled Substances Act (21 U.S.C.A. § 321 et seq.) or The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101-780-144) or the rules and regulations promulgated thereunder constitutes a violation of this chapter and of the act.

(v) A drug order in an institution is not required to conform to the labeling requirements of subsection (d) as long as the drug is dispensed in unit dose. A drug not in unit dose shall be labeled to indicate the patient name, drug name, drug strength, dosing instructions and lot number. The label of a parenteral, enteral or total parenteral nutrition product shall contain the name of the patient; the ingredients, including the name, strength, quantity of each, the diluent and expiration date; and the initials of the pharmacist.