Section 7.12. Central fill pharmacy.

 

(1)  In this section:

(a) "Central fill pharmacy" means a pharmacy licensed in this state acting as an agent of an originating pharmacy to fill or refill a prescription.

(b) "Originating pharmacy" means a pharmacy licensed in this state that uses a central fill pharmacy to fill or refill a prescription order.

(2)  A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription order received by an originating pharmacy only pursuant to the following requirements:

(a) The central fill pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law.

(b) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address and DEA number, for which it processes a request for the filling or refilling of a prescription order received by the originating pharmacy. The record shall be made available upon request for inspection by the board or its agent.

(c) The central fill pharmacy and originating pharmacy maintain a written filling protocol delineating each pharmacy's assumption of responsibility for compliance with the prescription drug compounding and dispensing requirements of this chapter and ch. Phar 8 .

(d) The originating pharmacy shall remain responsible for compliance with the prescription drug compounding and dispensing requirements of this chapter and ch. Phar 8 , and which are not assumed in writing by the central fill pharmacy pursuant to a written filling protocol.

(e) The originating pharmacy shall at all times remain solely responsible to perform and comply with the requirements of s. Phar 7.01 (1) (e) and (em) .

(f) Unless the central fill pharmacy shares a common central processing unit with the originating pharmacy, it may not perform processing functions such as the medication profile record review of the patient, drug utilization review, refill authorizations, interventions and drug interactions.

(g) The prescription label attached to the container shall contain the name and address of the originating pharmacy as the licensed facility from which the prescribed drug or device was dispensed for purposes of s. 450.11 (4) (a) 1. , Stats. The date on which the prescription was dispensed for purposes of s. 450.11 (4) (a) 2. , Stats., shall be the date on which the central fill pharmacy filled the prescription order.

(h) The originating pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law.

(i) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill prescription orders for purposes of filing and recordkeeping as required by state and federal law.

(j) In addition to meeting the other recordkeeping requirements required by state and federal law, the central fill pharmacy and originating pharmacy shall each maintain records to identify each of its pharmacists responsible for receiving and reviewing prescription orders and compounding and dispensing pursuant to a prescription order and track the prescription order during each step in the dispensing process.

(k) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and insure compliance with this section.

(L) The originating pharmacy shall provide the patient with the name and address of the central fill pharmacy and obtain consent as required by applicable state and federal law.

CR 01-075 : cr. Register November 2003 No. 575 , eff. 12-1-03; CR 09-098 : am. (2) (f) Register May 2010 No. 653 , eff. 6-1-10.