| (a) Licensing requirements.
(1) A Class A pharmacy shall register annually or biennially
with the board on a pharmacy license application provided by the board,
following the procedures as specified in §291.1 of this title
(relating to Pharmacy License Application).
(2) A Class A pharmacy which changes ownership shall
notify the board within ten 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).
(3) A Class A pharmacy which changes location and/or
name shall notify the board as specified in §291.3 of this title.
(4) A Class A 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 ten days of the change,
following the procedures as specified in §291.3 of this title.
(5) A Class A pharmacy shall notify the board in writing
within ten days of closing, following the procedures as specified
in §291.5 of this title (relating to Closing a Pharmacy).
(6) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(7) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for the issuance
and renewal of a license and the issuance of an amended license.
(8) A Class A pharmacy, licensed under the provisions
of the Act, §560.051(a)(1), which also operates another type
of pharmacy which would otherwise be required to be licensed under
the Act, §560.051(a)(2) concerning Nuclear Pharmacy (Class B),
is not required to secure a license for such other type of pharmacy;
provided, however, such licensee is required to comply with the provisions
of Subchapter C of this chapter (relating to Nuclear Pharmacy (Class
B)), to the extent such sections are applicable to the operation of
the pharmacy.
(9) A Class A pharmacy engaged in the compounding of
non-sterile preparations shall comply with the provisions of §291.131
of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(10) A Class A pharmacy shall not compound sterile
preparations.
(11) A Class A pharmacy engaged in the provision of
remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.121 of this title
(relating to Remote Pharmacy Services).
(12) Class A pharmacy engaged in centralized prescription
dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.123 of this title (relating
to Central Prescription Drug or Medication Order Processing) and/or §291.125
of this title (relating to Centralized Prescription Dispensing).
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an orderly fashion
and kept clean. All required equipment shall be clean and in good
operating condition.
(B) A Class A pharmacy shall have a sink with hot and
cold running water within the pharmacy, exclusive of restroom facilities,
available to all pharmacy personnel and maintained in a sanitary condition.
(C) A Class A pharmacy which serves the general public
shall contain an area which is suitable for confidential patient counseling.
(i) Such counseling area shall be:
(I) easily accessible to both patient and pharmacists
and not allow patient access to prescription drugs; and
(II) designed to maintain the confidentiality and privacy
of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for
confidential patient counseling and designed to maintain the confidentiality
and privacy of the pharmacist/patient communication, the board may
consider factors such as the following:
(I) the proximity of the counseling area to the check-out
or cash register area;
(II) the volume of pedestrian traffic in and around
the counseling area;
(III) the presence of walls or other barriers between
the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being
overheard by persons other than the patient or patient's agent or
the pharmacist or agents of the pharmacist.
(D) The pharmacy shall be properly lighted and ventilated.
(E) The temperature of the pharmacy shall be maintained
within a range compatible with the proper storage of drugs. The temperature
of the refrigerator shall be maintained within a range compatible
with the proper storage of drugs requiring refrigeration.
(F) Animals, including birds and reptiles, shall not
be kept within the pharmacy and in immediately adjacent areas under
the control of the pharmacy. This provision does not apply to fish
in aquariums, service animals accompanying disabled persons, or animals
for sale to the general public in a separate area that is inspected
by local health jurisdictions.
(G) If the pharmacy has flammable materials, the pharmacy
shall have a designated area for the storage of flammable materials.
Such area shall meet the requirements set by local and state fire
laws.
(2) Security.
(A) 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 drugs,
and records for such drugs.
(B) The prescription department shall be locked by
key, combination or other mechanical or electronic means to prohibit
unauthorized access when a pharmacist is not on-site except as provided
in subparagraphs (C) and (D) of this paragraph and paragraph (3) of
this subsection. The following is applicable:
(i) If the prescription department is closed at any
time when the rest of the facility is open, the prescription department
must be physically or electronically secured. The security may be
accomplished by means such as floor to ceiling walls; walls, partitions,
or barriers at least 9 feet 6 inches high; electronically monitored
motion detectors; pull down sliders; or other systems or technologies
that will secure the pharmacy from unauthorized entrance when the
pharmacy is closed. Pharmacies licensed prior to June 1, 2009, shall
be exempt from this provision unless the pharmacy changes location.
Change of location shall include the relocation of the pharmacy within
the licensed address. A pharmacy licensed prior to June 1, 2009 that
files a change of ownership but does not change location shall be
exempt from the provisions.
(ii) The pharmacy's key, combination, or other mechanical
or electronic means of locking the pharmacy may not be duplicated
without the authorization of the pharmacist-in-charge or owner.
(iii) At a minimum, the pharmacy must have a basic
alarm system with off-site monitoring and perimeter and motion sensors.
The pharmacy may have additional security by video surveillance camera
systems.
(C) Prior to authorizing individuals to enter the prescription
department, the pharmacist-in-charge or owner may designate persons
who may enter the prescription department to perform functions, other
than dispensing functions or prescription processing, documented by
the pharmacist-in-charge including access to the prescription department
by other pharmacists, pharmacy personnel and other individuals. The
pharmacy must maintain written documentation of authorized individuals
other than individuals employed by the pharmacy who accessed the prescription
department when a pharmacist is not on-site.
(D) Only persons designated either by name or by title
including such titles as "relief" or "floater" pharmacist, in writing
by the pharmacist-in-charge may unlock the prescription department
except in emergency situations. An additional key to or instructions
on accessing the prescription department may be maintained in a secure
location outside the prescription department for use during an emergency
or as designated by the pharmacist-in-charge.
(E) Written policies and procedures for the pharmacy's
security shall be developed and implemented by the pharmacist-in-charge
and/or the owner of the pharmacy. Such policies and procedures may
include quarterly audits of controlled substances commonly abused
or diverted; perpetual inventories for the comparison of the receipt,
dispensing, and distribution of controlled substances; monthly reports
from the pharmacy's wholesaler(s) of controlled substances purchased
by the pharmacy; opening and closing procedures; product storage and
placement; and central management oversight.
(3) Temporary absence of pharmacist.
(A) On-site supervision by pharmacist.
Cont'd... |
