(a) All retail pharmacies operating in this
State must meet the following requirements:
(i) The pharmacy shall include a sink with a
hot and cold water supply, exclusive of restroom facilities, with adequate
sewage disposal;
(ii) The pharmacy
shall be properly lighted and ventilated. The temperature of the pharmacy shall
be maintained within a range compatible with the proper storage of
pharmaceuticals;
(iii) The pharmacy
shall have adequate shelving; there shall be adequate counter space; the
working surface shall be kept clear and uncluttered at all times for the
preparation or compounding of prescriptions to meet the requirements of the
pharmacy. Any pharmacy where compounding prescriptions occurs must meet the
structural and equipment requirements identified in Chapter 13 of these
rules;
(iv) A fax machine or
similar electronic equipment capable of producing an identical document shall
be located in the pharmacy;
(v) A
separate refrigerator located in the pharmacy, with sufficient capacity to
serve the needs of the pharmacy, equipped with a thermometer which provides a
storage temperature of 36-46 degrees Fahrenheit (2-8 degrees Centigrade). The
use of such refrigerator shall be limited to the storage of drugs. If a freezer
compartment is utilized, it must maintain a temperature of -13 to 14 degrees
Fahrenheit (-20 to -10 degrees Centigrade);
(vi) Class A prescription balance or
electronic scale with 10mg sensitivity if the pharmacy participates in
compounding. Pharmacies that do not compound or do not dispense are not
required to obtain or maintain a prescription balance or electronic
scale;
(vii) A professional
reference library (text or electronic format) that shall include the following:
(A) Current Wyoming pharmacy laws;
(B) Current edition of Facts and
Comparisons or a comparable reference accepted by the Board;
(C) Current drug interaction text that
provides, at a minimum, quarterly updates;
(D) Wyoming State Board of Pharmacy quarterly
newsletter by access to the Board website; and
(E) The current edition (as incorporated by
reference in this Chapter), with supplements, of the U.S. Food and Drug
Administration (FDA) "Orange Book" or an alternate reference that provides the
same information as the FDA "Orange Book." Proven access to the Board website
link to the Orange Book meets this requirement.
(viii) Pharmacies must maintain adequate
security to deter theft of drugs by personnel or public. Security requirements
for new or remodeled pharmacies must meet the requirements of this chapter. No
person other than the pharmacist, intern or technician employed by the pharmacy
shall be permitted in the pharmacy without the express consent of the PIC. If
the pharmacy is located in a facility in which the public has access and the
pharmacy's hours of operation are different from the rest of the facility, the
pharmacy must be designed so that it can be securely locked and made
inaccessible when the pharmacy is not open;
(ix) The pharmacy shall be arranged in an
orderly fashion and kept clean. All required equipment shall be clean and in
good operating condition;
(x) If
automated counting devices are utilized, the pharmacy shall have a method to
calibrate and verify the accuracy of the automated counting device and shall
verify the accuracy and document doing so on a quarterly basis;
(xi) Consecutive numbering of all
prescriptions must be maintained, along with appropriate printing equipment to
product prescription drug labels; and
(xii) In addition to the requirements
identified in this chapter, all pharmacies involved in the preparation of
sterile compounded products must meet the requirements of Chapter 17 of these
rules.
(b) In addition to
the requirements of this chapter, except for a change of ownership of an
existing pharmacy, an individual or business who opens a new pharmacy or
remodels an existing retail pharmacy shall provide to the Board staff no later
than thirty (30) calendar days prior to commencing construction or remodeling
the pharmacy, a set of blueprints or other acceptable documents, which indicate
the physical layout of the planned or remodeled pharmacy.
(c) The proposed new pharmacy or pharmacy to
be remodeled shall meet the following minimum standards:
(i) The pharmacy shall consist of no less
than 500 square feet;
(ii) The
pharmacy shall include an identified counseling area, which is apart from the
cash register, apart from the prescription "pick up" area, and offers
sufficient privacy for counseling. A separation of three (3) feet is the
minimum space between patients to allow for privacy during counseling.
Pharmacies that do not provide prescription services to "Walk-in" customers are
not required to have a counseling area;
(iii) Located within the pharmacy, but not
counted in the square footage requirements of the pharmacy, shall be restroom
facilities, access to which shall be limited to pharmacy staff;
(iv) Access to the pharmacy shall be secured
as follows:
(A) If the pharmacy is located
within another business, which does not have identical hours of operation, the
pharmacy shall be secured with solid core or metal doors with a deadbolt and a
locking doorknob. If glassed areas are utilized, then adequate intrusion
detectors must be in place. Pharmacy walls must extend to the roof or provide
security acceptable to the Board. The pharmacy shall meet all other applicable
federal or state regulations concerning security access.
(B) Those pharmacies not included in (A)
shall be secured with solid core, metal or safety glass exterior doors secured
with a deadbolt, and must utilize an adequate intrusion detector. If the
pharmacy shares a common wall with another business, this wall must extend to
the roof. The pharmacy shall meet all other applicable federal or state
regulations concerning security access.
(v) A separate refrigerator, sufficient in
capacity to serve the needs of the pharmacy staff, shall be available for
storage of employees' food or beverage. This refrigerator shall be identified
for "Employee Use Only"; and
(vi)
All prescription data shall be processed utilizing electronic data processing
equipment and shall be sequentially numbered. There shall be adequate computer
terminals and printers available to process anticipated prescription volume for
the new or remodeled pharmacy.
(d) Upon written request, and for good cause,
the Board may waive any of the requirements of this chapter. A waiver that is
granted under this section shall only be effective when issued by the Board in
writing.
(e) For a change in
ownership of a retail or institutional pharmacy, the Board shall be notified at
least twenty-one (21) days before the change.