Tenn. Comp. R. & Regs. 1140-01-.13 - STANDARDS FOR PHARMACIES AND PRESCRIPTION DEPARTMENT SECURITY

A license to operate a new or remodeled pharmacy practice site, or an existing pharmacy practice site which changes location or ownership, will not be issued unless the pharmacy practice site meets the following standards.

(1) The pharmacy practice site and equipment therein shall be maintained in a clean, sanitary, orderly and well-lighted condition, and all persons working in the pharmacy practice site shall be required to keep themselves and their apparel in a clean and sanitary condition.

(2) All new or relocated pharmacies opening after July 1, 1998 shall provide a consultation area which offers sufficient privacy to the patient before a license will be issued. All existing pharmacies shall be in compliance with this requirement on or before January 1, 2000.

(3) If the practice site is a dispensing pharmacy, the prescription department at the pharmacy practice site shall meet the following standards.

(a) The department shall have necessary counters and storage space.

(b) The department shall have a representative stock of prescription drugs and devices and related materials sufficient to compound and dispense medical and prescription orders as indicated by experience.

(c) The department shall have the apparatus and equipment needed to compound and dispense medical and prescription orders properly.

(d) The department shall occupy a space of not less than one hundred eighty (180) square feet.

(e) The department shall have hot and cold running water and immediate area refrigeration.

(f) The department shall have a physical barrier sufficient to protect against unauthorized entry and pilferage of prescription drugs and devices and related materials.

(g) Keys or other access devices to the physical barriers shall be subject to the following standards.

1. Only pharmacists practicing at the pharmacy and pharmacists authorized by the pharmacist in charge shall be in possession of any keys or other access devices.

2. The pharmacist in charge shall place a key or other access device in a sealed device or vault in a secured place outside of the department, unless the pharmacy practice utilizes an electronic access device which is capable of restricting and preventing unauthorized access into the pharmacy. The key or access device may be used to allow emergency entrance to the department. A written or electronic record of persons accessing the pharmacy department using the key or other access device must be maintained on the premises of that pharmacy practice site for a period of 2 years.

(h) Access to the department is restricted to pharmacists, pharmacy interns and pharmacy technicians who are practicing at the pharmacy. Other persons designated by the pharmacist in charge may be allowed access but only during hours that a pharmacist is on duty.

(i) Notwithstanding any rule or regulation to the contrary, a pharmacy which was established before June 6, 1945, and which serves food, and which has continuously had a soda fountain, may allow a customer to go through the pharmacy area to the restroom, and not be required to have a gate or door to separate the pharmacy from the restroom or other parts of the establishment.

(4) All licenses and certificates of registration for a pharmacy practice site shall at all times be conspicuously displayed at the practice site.

(5) If a pharmacy practice site is located in a mercantile establishment (such as a discount store, grocery store, department store, or other similar establishment), then such pharmacy practice site shall be:

(a) open for business during the same hours as the mercantile establishment, unless the pharmacy practice site is capable of being closed-off by physical barrier from floor to ceiling; and

(b) under the supervision of a pharmacist at all times; except as provided in rule 1140-03-.07.

(6) The pharmacist shall not at any time be denied access to the prescription department of a pharmacy practice site located in a mercantile establishment; provided, however, that entry of the pharmacist at times when the pharmacy is closed to the public may be subject to reasonable and prudent conditions.

(7) A pharmacy practice site where prescription drugs and devices and related materials are received, stored, compounded and dispensed shall not be opened for business or any other reason unless a licensed pharmacist is present. Furthermore, no medical or prescription order shall be dispensed except during the presence and under the direct supervision of a pharmacist.

(8) Nothing in this rule applies to a pharmacy practice site or prescription department operating in an institutional facility.

(9) In cases of practical difficulty or undue hardship, the board may permit exceptions to the standards specified in this rule.

Notes

Tenn. Comp. R. & Regs. 1140-01-.13

Original rule filed May 11, 1998; effective July 25, 1998. Emergency rule filed January 31, 2014; effective through July 30, 2014. Emergency rule filed January 31, 2014 expired effective July 31, 2014. The rule reverted to its previous status. Rule filed July 11, 2014 and was previously numbered 1140-01-.12, but was changed effective October 10, 2014 with an addition of a new 1140-01-.12. Rule was renumbered 1140-01-.13. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(28), 63-10-504(b)(1), and 63-10-504(b)(1) and (2).