Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

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The Pennsylvania Code website reflects the Pennsylvania Code changes effective through 52 Pa.B. 2550 (April 23, 2022).

49 Pa. Code § 27.18. Standards of practice.

§ 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:

   (1)  Prescriptions on file must show the name and address of the patient; the name and address or other identifier of the prescriber; the date the prescription was issued, if the prescription is for a controlled substance or if it was written with a PRN or ad lib refill designation; the name and quantity of the drug prescribed; directions for its use; cautions communicated to the ultimate consumer by means of auxiliary labels or other means when dispensed to the ultimate consumer; the date the prescription was compounded and dispensed; and the name or initials of the dispensing pharmacist.

   (2)  Prescriptions for controlled substances must show the DEA number of the prescriber. Prescriptions for Schedule II controlled substances must be written with ink, indelible pencil, typewriter, word processor, computer printer or by electronic means and shall be manually signed by the prescriber, except that prescriptions written by electronic means shall be electronically signed by the prescriber. Electronic prescriptions of Schedule II controlled substances must comply with §  27.201(b) (relating to electronically transmitted prescriptions). The pharmacist is responsible for compounding and dispensing nonproprietary drugs consistent with the Federal Controlled Substances Act (21 U.S.C.A. § §  801—904), The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) and the regulations promulgated under these acts.

   (3)  If a prescription for a nonproprietary drug is refilled, a record of the refill must show the date of the refill, the name or initials of the dispensing pharmacist and the quantity dispensed. If the pharmacist dispenses a quantity different from that of the original prescription, the pharmacist shall indicate the changes on the back of the original prescription or must enter the changes in the computerized files of the pharmacy.

   (4)  Original prescriptions or readily retrievable images of the original prescriptions shall be kept for 2 years from the date of the most recent filling.

   (5)  In an institution, Schedule II controlled substances which the pharmacy dispensed and which were ultimately received by the patient shall be recorded and the record kept for 2 years.

 (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:

   (1)  The name, address, telephone number and DEA number of the pharmacy.

   (2)  The name of the patient.

   (3)  Full directions for the use of its contents.

   (4)  The name of the prescriber.

   (5)  The serial number of the prescription and the date originally filled.

   (6)  The trade or brand name of the drug, strength, dosage form and quantity dispensed. If a generic drug is dispensed, the manufacturer’s name or suitable abbreviation of the manufacturer’s name shall also be shown.

   (7)  On controlled substances, the statement: ‘‘Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.’’

 (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:

   (1)  Prescription medication shall be sent only in first class mail or common carrier, except where the purchaser is advised in advance that a slower means of transportation will be used and agrees thereto.

   (2)  The mailing of antibiotics which have been reconstituted is prohibited.

   (3)  The mailing of a medication or prescription drug or device generally accepted and recognized to be subject to significant deterioration of the original content due to heat, cold fermentation or prolonged agitation is permissible if it is shipped in a manner which would preserve the integrity of the drug, such as cold packs or other temperature control devices and sensors that would alert the patient if the integrity of the drug was compromised.

 (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:

   (1)  A pharmacist practicing in a hospital, institution or similar place or specialized ambulatory care unit may not be required to extend pharmaceutical services to other than registered patients of that hospital or institution.

   (2)  A pharmacist shall offer complete pharmaceutical service by compounding or dispensing prescriptions which may reasonably be expected to be compounded or dispensed by pharmacists to meet the needs of persons who would usually attempt to utilize the services.

   (3)  A pharmacist shall safeguard the storage and distribution of prescription drugs and devices under Commonwealth and Federal statutes, maintaining proper records therefor and shall, upon request, advise concerning contents, therapeutic values and uses of the drugs, devices and articles.

   (4)  No pharmacy or pharmacist may discriminate against a person on account of race, creed, religion, national origin or sex.

 (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:

   (1)  A person may not advertise the filling or refilling of prescriptions for a consumer or patient in this Commonwealth if that person is not licensed under the act or the prescription is not filled or refilled in a pharmacy licensed by the Board.

   (2)  A person may not promote to the public the sale of any controlled substances.

   (3)  Advertisements of prescription drugs and devices may not be false or misleading, and must be truthful, reasonable, informative and understandable to the public.

   (4)  A drug or device misbranded or adulterated in Federal law is misbranded and adulterated in Commonwealth law.

   (5)  An advertisement of a prescription must be for a commercially reasonable quantity.

   (6)  A person advertising special prices for prescriptions, dangerous drugs or nonproprietary drugs, preparations or products, devices and appliances, if using a percentage number such as 10% off, 20% off, and the like, as to selected items, shall state or publish a price list from which the percentage prices are derived, so the consumer or patient knows exactly what the retail price is.

   (7)  The patient has the right to request a copy of an original prescription. The copy must clearly indicate on its face that it is a copy and may not be used to obtain a new prescription or refill. Before a pharmacist provides a copy of a written prescription to a patient or an authorized agent of the patient, the person requesting the copy shall show the pharmacist acceptable authorization and identification, such as a driver’s license. The pharmacist shall record in writing the date, to whom and by whom the copy was given.

   (8)  A violation of the Unfair Trade Practices and Consumer Protection Law (73 P. S. § §  201-1—201-9.2) is a violation of this chapter.

 (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:

   (1)  Hypodermic needles and syringes may be sold without a prescription.

   (2)  Hypodermic needles and syringes shall be kept in the prescription area of the pharmacy, as defined in §  27.1 (relating to definitions), and be accessible only by pharmacists and pharmacy personnel authorized to be in the prescription area of the pharmacy while the pharmacy is open.

 (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.

Authority

   The provisions of this §  27.18 amended under section 6(k)(9) of the Pharmacy Act (63 P.S. §  390-6(k)(9)).

Source

   The provisions of this §  27.18 amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended September 11, 2009, effective immediately, 39 Pa.B. 5312; amended December 24, 2009, effective December 26, 2009, 39 Pa.B. 7205; amended August 10, 2012, effective August 11, 2012, 42 Pa.B. 5182; amended November 30, 2018, effective December 1, 2018, 48 Pa.B. 7404. Immediately preceding text appears at serial pages (362964) to (362969).

Notes of Decisions

   Revocation of a pharmacist’s license for a violation of 49 Pa. Code §  27.18(u) (relating to violations by a pharmacist of the Federal Controlled Substances Act (21 U.S.C. §  321 et seq.) or the Pennsylvania Controlled Substances, Drug, Devices and Cosmetic Act (35 P. S. § §  780-101—780-144)) is not an abuse of discretion. Rosenthal v. State Board of Pharmacy, 457 A.2d 243 (Pa. Cmwlth. 1983).

   If a pharmacist has been charged only with violations of the Pharmacy Act (63 P. S. § §  390-1—390-13) and the Board’s regulations, the Board’s authority to revoke or suspend his license is governed by the provisions of section 5(a)(6) of the Pharmacy Act (63 P. S. §  390-5(a)(6)); the provisions of section 23(b) of the Drug Act (35 P. S. §  780-123(b)) are not applicable, even though the violations may also constitute grounds for a criminal prosecution. Moeslein v. State Board of Pharmacy, 432 A.2d 295 (Pa. Cmwlth. 1981).

   With regard to the prohibitions of subsection (t), it is irrelevant whether a pharmacist continually fills overlapping prescriptions for the same person, from the same physician, and for the same drug, in the same quantity and dosage, or continually refills a prior prescription; the subsection gives a clear description of what conduct is prohibited such that it satisfies due process requirements. Goldberg v. State Board of Pharmacy, 410 A.2d 413 (Pa. Cmwlth. 1980).

   Revocation of a pharmacist’s license for distributing cocaine and dexedrine without a prescription is not an unduly harsh punishment; the classification of cocaine as a controlled substance is not a denial of equal protection. Carr v. State Board of Pharmacy, 409 A.2d 941 (Pa. Cmwlth. 1980).

   Since the petitioner pled guilty to four criminal charges under the Drug Act, only one of which was a felony, the Board has the power to revoke his license but is not obligated to do so, and the case will be remanded if it appears that the Board’s decision to revoke his license is based in part on the mistaken belief that a plea of guilty to any offense in connection with the practice of pharmacy is sufficient to revoke a license. Intrieri v. Commissioner of Professional and Occupational Affairs, 396 A.2d 927 (Pa. Cmwlth. 1979).

Cross References

   This section cited in 6 Pa. Code §  11.142 (relating to labeling of medications); 6 Pa. Code §  22.62 (relating to conditions of provider participation); 6 Pa. Code §  22.63 (relating to other provisions for providing services by mail); 28 Pa. Code §  113.25 (relating to drug distribution systems); 49 Pa. Code §  27.12 (relating to practice of pharmacy and delegation of duties); 49 Pa. Code §  27.101 (relating to radiopharmaceutical prescriptions—statement of policy); 49 Pa. Code §  27.201 (relating to electronically transmitted prescriptions); 49 Pa. Code §  27.202 (relating to computerized recordkeeping systems); 49 Pa. Code §  43b.7 (relating to schedule of civil penalties—pharmacists and pharmacies); 49 Pa. Code §  27.605 (relating to label information required); and 49 Pa. Code §  27.606 (relating to compounding records).



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