49 Pa. Code § 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.
Notes
The provisions of this § 27.18 amended under
section 6(k)(9) of the
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
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