| (vi) communicating to the patient or the patient's
agent on his or her request information concerning any prescription
drugs dispensed to the patient by the pharmacy;
(vii) assuring that a reasonable effort is made to
obtain, record, and maintain patient medication records; and
(viii) interpreting patient medication records and
performing drug regimen reviews.
(4) Pharmacy Technicians and Pharmacy Technician Trainees.
(A) General. All pharmacy technicians and pharmacy
technician trainees shall meet the training requirements specified
in §297.6 of this title (relating to Pharmacy Technician and
Pharmacy Technician Trainee Training).
(B) Duties.
(i) Pharmacy technicians and pharmacy technician trainees
may not perform any of the duties listed in paragraph (3)(B) of this
subsection.
(ii) A pharmacist may delegate to pharmacy technicians
and pharmacy technician trainees any nonjudgmental technical duty
associated with the preparation and distribution of prescription drugs
provided:
(I) a pharmacist verifies the accuracy of all acts,
tasks, and functions performed by pharmacy technicians and pharmacy
technician trainees; and
(II) pharmacy technicians and pharmacy technician trainees
are under the direct supervision of and responsible to a pharmacist.
(iii) Pharmacy technicians and pharmacy technician
trainees may perform only nonjudgmental technical duties associated
with the preparation of prescription drugs, as follows:
(I) initiating and receiving refill authorization requests;
and
(II) entering prescription or medication order data
into a data processing system.
(iv) In addition to the duties listed above in clause
(iii) of this subparagraph, pharmacy technicians may perform the following
nonjudgmental technical duties associated with the preparation and
distribution of prescription drugs:
(I) receiving oral prescription drug or medication
orders for dangerous drugs and reducing these orders to writing, either
manually or electronically; and
(II) transferring or receiving a transfer of original
prescription drug or medication order information for a dangerous
drug on behalf of a patient.
(5) Identification of pharmacy personnel. All pharmacy
personnel shall be identified as follows.
(A) Pharmacy technicians. All pharmacy technicians
shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacy technician, or a certified
pharmacy technician, if the technician maintains current certification
with the Pharmacy Technician Certification Board or any other entity
providing an examination approved by the board.
(B) Pharmacy technician trainees. All pharmacy technician
trainees shall wear an identification tag or badge that bears the
person's name and identifies him or her as a pharmacy technician trainee.
(C) Pharmacist interns. All pharmacist interns shall
wear an identification tag or badge that bears the person's name and
identifies him or her as a pharmacist intern.
(D) Pharmacists. All pharmacists shall wear an identification
tag or badge that bears the person's name and identifies him or her
as a pharmacist.
(d) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy may outsource
prescription drug or medication order processing to a Class G pharmacy
provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which
outlines the services to be provided and the responsibilities and
accountabilities of each pharmacy in compliance with federal and state
laws and regulations; and
(ii) share a common electronic file or have appropriate
technology to allow access to sufficient information necessary or
required to perform a non-dispensing function.
(B) A Class G pharmacy shall comply with the provisions
applicable to the class of pharmacy contained in §§291.31
- 291.35 of this title (relating to Definitions, Personnel, Operational
Standards, Records, and Official Prescription Requirements in a Class
A (Community) Pharmacy), §§291.72 - 291.75 of this title
(relating to Definitions, Personnel, Operational Standards, and Records
in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105
of this title (relating to Definitions, Personnel, Operational Standards,
and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable
for the specific processing activity and this section including:
(i) duties which must be performed by a pharmacist;
and
(ii) supervision requirements for pharmacy technicians
and pharmacy technician trainees.
(2) Licensing requirements.
(A) A Class G pharmacy shall register with the board
on a pharmacy license application provided by the board, following
the procedures specified in §291.1 of this title (relating to
Pharmacy License Application).
(B) A Class G pharmacy which changes ownership shall
notify the board within 10 days of the change of ownership and apply
for a new and separate license as specified in §291.3 of this
title (relating to Required Notifications).
(C) A Class G pharmacy which changes location and/or
name shall notify the board of the change within 10 days and file
for an amended license as specified in §291.3 of this title.
(D) A Class G pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing
of the names of the new managing officers within 10 days of the change,
following the procedures in §291.3 of this title.
(E) A Class G pharmacy shall notify the board in writing
within 10 days of closing, following the procedures in §291.5
of this title (relating to Closing a Pharmacy).
(F) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for issuance and
renewal of a license and the issuance of an amended license.
(G) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(3) Environment.
(A) General requirements.
(i) The pharmacy shall be arranged in an orderly fashion
and kept clean. All required equipment shall be in good operating
condition.
(ii) The pharmacy shall be properly lighted and ventilated.
(iii) The pharmacy is not required to have a sink exclusive
of restroom facilities.
(B) Security.
(i) Each pharmacist while on duty shall be responsible
for the security of the prescription department, including provisions
for effective control against theft or diversion of prescription drug
records.
(ii) Pharmacies shall employ appropriate measures to
ensure that security of prescription drug records is maintained at
all times to prohibit unauthorized access.
(4) Policy and Procedures. A policy and procedure manual
shall be maintained by the Class G pharmacy and be available for inspection.
The manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone
numbers, and all license/registration numbers of the pharmacies involved
in centralized prescription drug or medication order processing; and
(C) include policies and procedures for:
(i) protecting the confidentiality and integrity of
patient information;
(ii) maintaining appropriate records to identify the
name(s), initials, or identification code(s) and specific activity(ies)
of each pharmacist or pharmacy technician who performed any processing;
(iii) complying with federal and state laws and regulations;
(iv) operating a continuous quality improvement program
for pharmacy services designed to objectively and systematically monitor
and evaluate the quality and appropriateness of patient care, pursue
opportunities to improve patient care, and resolve identified problems;
and
(v) annually reviewing the written policies and procedures
and documenting such review.
(e) Records.
(1) every record required to be kept under the provisions
of this section shall be:
(A) kept by the pharmacy and be available, for at least
two years from the date of such inventory or record, for inspecting
and copying by the board or its representative and to other authorized
local, state, or federal law enforcement agencies; and
Cont'd... |
