059-19 Wyo. Code R. §§ 19-10 - Minimum Structural and Equipment Requirements to Operate a Retail Pharmacy

(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.

Notes

059-19 Wyo. Code R. §§ 19-10

Adopted, Eff. 12/19/2018.