247 CMR, § 9.04 - Requirements for Dispensing and Refilling Prescriptions
(1) A licensed pharmacist is responsible for
the final dispensing process validation of a prescription.
(2) A pharmacy shall utilize a computerized
pharmacy system for processing prescriptions and for maintaining patient
profiles.
(3) A licensee shall
ensure the label affixed to a prescription drug container or package is clearly
printed by a computerized pharmacy system. In the event of printing or
equipment failure, a prescription label may be legibly handwritten or typed
during an emergency period.
(4) A
pharmacy that provides bed-side delivery service of discharge prescriptions to
patients in an inpatient healthcare facility must obtain patient consent to
provide such services and may not restrict a patient's freedom of choice of
pharmacy services. A pharmacy that provides bed-side delivery service shall
deliver any medications directly to the patient or patient's agent.
(5) A licensee shall adhere to 105 CMR
721.000: Standards for Prescription Format and Security in
Massachusetts when dispensing a controlled substance in Schedule II in
an emergency situation.
(6) A
pharmacist who refills a prescription for a controlled substance in Schedules
III through VI shall record the following information in the computerized
pharmacy system or on the written prescription:
(a) the date of dispensing;
(b) the amount of drug dispensed;
and
(c) his or her
initials.
(7) Whenever a
prescription drug has been distributed solely under a generic name, the
dispensing pharmacist shall record the NDC number in the computerized pharmacy
system. In the event an NDC number does not exist, the pharmacist shall record
the name of the manufacturer, or, if the manufacturer's name is not available,
the name of the distributor, packer, or repacker.
(8) A pharmacy intern, or certified pharmacy
technician who has the approval of the pharmacist on duty may receive new
prescriptions over the telephone from a prescriber or authorized
agent.
(9) A pharmacist or
individual acting on behalf of a pharmacy may not collect prescriptions at
industrial plants, places of business, or other sites where specific groups of
people are regularly employed or affiliated, unless the following requirements
are met:
(a) the prescriptions are written for
persons regularly employed at, or affiliated with, such plant, place of
business, or other such site or the immediate family members living at the same
address of persons regularly employed at, or affiliated with, such plant, place
of business, or other such site;
(b) a pharmacist, pharmacy employee, or
authorized agent of the pharmacy collects the prescriptions in
person;
(c) a pharmacist, pharmacy
employee, or authorized agent of the pharmacy dispenses the prescription
medications directly to the patient or patient's agent;
(d) a pharmacist, pharmacy employee, or
authorized agent of the pharmacy returns all prescription medications that he
or she does not dispense directly to a patient or patient's agent to the
pharmacy. Prescription medications may not be left or stored at the delivery
location; and
(e) the pharmacist
and pharmacy shall be responsible for the conduct of any pharmacy employee or
authorized agent acting on the pharmacist's behalf.
(10) In order to determine whether a
prescription is within date, a pharmacist shall count the day after the
prescription was written as day one.
(11) A pharmacy may not dispense any
medication that was processed outside its licensed pharmacy premises unless
said process was verified by a Massachusetts licensed pharmacist or performed
in a pharmacy licensed by the Board.
(12) A prescription for a Schedule VI
medication is valid for one year from the date of issue. A licensee may not
refill a Schedule VI prescription after one year. In the event a Schedule VI
prescription expires or has no remaining refills and the pharmacist is unable
to obtain prescriber authorization in a timely manner, the pharmacist in his or
her professional judgment may dispense a quantity not to exceed 14 days or the
smallest available unit of use packaging.
(13) A licensee may not fill or refill a
prescription for a Schedule V controlled substance more than six months after
the date on which said prescription was issued. A prescription for a Schedule V
controlled substance may not be refilled more than five times.
(14) Requirements for Positive Identification
for Dispensing of a Controlled Substance in Schedule II through V:
(a) For the purposes of
247
CMR 9.04, Customer Identifier means the
identification number on a valid government issued identification, as specified
by the Department, which a licensee obtains by inspecting the identification of
the ultimate user or agent of the ultimate user to whom a prescription is
dispensed.
(b) A licensee shall
require that a Customer Identifier be presented by the ultimate user or agent
of the ultimate user to whom a prescription for a controlled substance in
Schedules II through V, or a controlled substance classified as an additional
drug in accordance with
105CMR 700.012(A)(1)
is dispensed.
(c) A licensee may dispense a controlled
substance in Schedule II through V or an additional drug without requiring a
customer identifier provided that:
1. the
licensee has reason to believe that the failure to dispense the controlled
substance or additional drug would result in a serious hardship for the
ultimate user or agent of the ultimate user, and documents the reason;
and
2. the ultimate user or agent
of the ultimate user prints his or her name and address on the reverse side of
the prescription or in an electronic or paper prescription log and signs his or
her name thereto.
(d) The
Commissioner may waive or modify the requirement for a customer identifier for
prescription refills, prescription deliveries or other activities specified in
the PMP Data Entry and Data Submitters Guide.
(15) The requirements of
247
CMR 9.04(4), (5), (6), (9), (10), (12), (13), and
(14) do not apply to institutional sterile
compounding pharmacies.
Notes
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