Section 856IAC1-13-3. "Prescription department closed" closing hours; electronic monitoring; applicability

   (a) This section and section 4 of this rule implement IC 25-26-13-19 concerning board approval for Type I and Type VI pharmacies to be opened to the general public without a pharmacist on duty. This section and section 4 of this rule apply only in situations where the entire area of the business is licensed as a pharmacy. This section, section 4 of this rule, and IC 25-26-13-19 do not apply where the only area of a business licensed as a pharmacy is the prescription department.

  (b) The following definitions apply throughout this section:

(1) "Absence of pharmacist" means those periods when the prescription department is closed and secured and the pharmacist is not present in the pharmacy.

(2) "Electronic monitoring system" means a system having the ability by light beam, heat, motion, or other electronically activated method to detect the presence of unauthorized persons or instrumentalities in a given area, and relay or report that detection as described in this section.

(3) "Prescription department" means that area of the pharmacy where the legend drugs, devices, and other merchandise or items which can only be dispensed or delivered by a pharmacist are located and which must be secured in the absence of the pharmacist.

(4) "Reasonable barrier" means an obstruction or barricade that blocks or impedes the entry into the area by an ordinary person, and includes, but is not limited to, a latched or locked gate of sufficient height and construction that an ordinary person cannot breach the barrier and/or violate the space being monitored without detection.

(5) "Secured" means either of the following:

(A) An area is completely enclosed as to its perimeter, from floor to ceiling, and locked.

(B) Through installation of reasonable barriers, an area not readily accessible which is monitored by a board approved electronic monitoring system covering all portions of the secured areas.

  (c) Before a pharmacy may be open to the general public without a pharmacist on duty, the pharmacy must file an application with the board and have it approved by the board under IC 25-26-13-19. The pharmacy must abide by the closing hours designated in the application. Any change from the hours as stated in the application must be submitted in writing to the board.

  (d) Under IC 25-26-13-19, a prescription department may be locked or secured while the remainder of the pharmacy remains open to the public if the following criteria are met:

(1) The prescription department is constructed in such a manner or located in such an area that reasonable barriers are in place which prevent the easy and/or quick access to legend drugs and other articles which are in the prescription department. These barriers may be doors or other obstacles as the occasion requires.

(2) The prescription department, if not secured and locked as described in subsection (b)(5)(A), must be secured and monitored by a board approved electronic monitoring device that provides the following:

(A) On-site audible alarm that is clearly and continuously audible at all points within the pharmacy.

(B) Off-site audible or visual alarm that is continuously monitored at all times that the pharmacy remains open while the prescription department is closed and secured.

(3) Any violation or breach of the secured area shall be duly recorded by the qualifying pharmacist of the pharmacy and by the off-site security monitoring agency and reported to the board within seventy-two (72) hours of the violation or breach. This report shall include the nature of the violation or breach.

(4) Facilities monitored electronically must provide for backup power for the eventuality that there is an electronic power failure for any reason. Such backup power shall be capable of continuing the monitoring for a period of no less than thirty-six (36) hours.

(5) The electronic monitoring system shall be activated and inactivated only by key or combination. Alarms which have been triggered shall only be reset and/or reactivated by a pharmacist. The key or combination shall only be in the possession or knowledge of a pharmacist. Reasonable exceptions shall be made to this for security system operators. However, in no case shall a security system operator have access to the secured area without the presence of a pharmacist. Such exceptions shall be listed in the application under this section and shall be subject to approval by the board.

  (e) Under IC 25-26-13-10(b), the board may revoke or limit the privilege to be open to the general public without a pharmacist on duty if the pharmacy violates this section or section 4 of this rule. (Indiana Board of Pharmacy; Reg 13, Sec 3; filed Jun 18, 1962, 10:00 a.m.: Rules and Regs. 1963, p. 124; filed May 15, 1992, 5:00 p.m.: 15 IR 2246; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)