Section 7.095. Operation of remote dispensing sites.

 

(1)   Definitions. In this section:

(a) "Health care facility" means a facility, as defined in s. 647.01 (4) , Stats., or any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health center or other place licensed or approved by the department of health services under s. 49.70 , 49.71 , 49.72 , 50.02 , 50.03 , 50.35 , 51.08 or 51.09 , Stats., or a facility under s. 45.50 , 51.05 , 51.06 , 233.40 , 233.41 , 233.42 or 252.10 , Stats.

(b) "Managing pharmacist" means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy.

(c) "Practitioner" means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.

(d) "Remote dispensing site" means a dispensing site that is not licensed as a pharmacy. Remote does not mean geographical distance or location.

(e) "Supervising pharmacy" means a licensed pharmacy that oversees the operations and administration of all aspects of the remote dispensing site.

(2)   Licensing requirements and use of titles relating to the operation of remote dispensing sites.

(a) A remote dispensing site shall not be licensed as a pharmacy.

(b) No person may use or display the title "pharmacy," "drugstore," "apothecary," or any other title, symbol or insignia having the same or similar meanings in connection with a remote dispensing site.

(3)   Location of remote dispensing sites. A pharmacist may dispense at the following locations:

(a) A health care facility or a facility identified under s. 980.065 , Stats.

(b) The office or clinic of a practitioner.

(c) A county jail, rehabilitation facility under s. 59.53 (8) , Stats., state prison under s. 302.01 , Stats., or county house of correction under s. 303.16 (1) , Stats.

(d) A juvenile correctional facility under s. 938.02 (10p) , Stats., juvenile detention facility under s. 938.02 (10r) , Stats., residential care center for children and youth under s. 938.02 (15d) , Stats., secured residential care center for children and youth under s. 938.02 (15g) , Stats., type 1 juvenile correctional facility under s. 938.02 (19) , Stats., type 2 residential care center for children and youth under s. 938.02 (19r) , Stats., or type 2 juvenile correctional facility under s. 938.02 (20) , Stats.

(4)   Requirements for the operation of remote dispensing sites.

(a) A remote dispensing site shall display a sign, easily viewable by customers, that states all of the following:

1. Prescriptions may be filled at this location.

2. This store is a remote dispensing site being supervised by a pharmacist located at all of the following:

a. Name of store.

b. Address of store.

c. Telephone number of store.

3. The pharmacist is required to talk to you each time you pick up a prescription.

(b) A remote dispensing site shall not open for operation if the supervising pharmacy is closed.

(c) A remote dispensing site shall not dispense a prescribed drug or device in the absence of the ability of a patient to communicate with the pharmacist.

(d) When closed, a remote dispensing site shall have a centrally monitored alarm. For all after hour entries, the personnel entering the site shall record their name, and the date, time and purpose for entering the site in a log. All logs shall be retained for 2 years.

(e) A remote dispensing site shall submit written notification to the board 30 days prior to operating the remote dispensing site.

(5)   Dispensing requirements. A remote dispensing site shall meet all of the following:

(a) Comply with the requirements under s. Phar 7.01 and visually inspect prescription orders, labels and dispensed product.

(b) Comply with the labeling requirements under s. Phar 7.12 (2) (g) . The prescription label shall contain the name and address of the supervising pharmacy as the licensed facility from which the prescribed drug or device was dispensed.

(c) Comply with federal law if a remote dispensing site dispenses controlled substances.

(6)   Responsibilities of managing pharmacists.

(a) The managing pharmacist of a remote dispensing site shall, in accordance with s. Phar 7.09 , do all of the following:

1. Have written policies and procedures for system operation, safety, security, accuracy and access.

2. Implement an on-going quality assurance program that monitors performance that includes the number of prescriptions dispensed per month, number of medication errors documented, loss or diversion of inventory, and documentation of remedial training to prevent future errors.

3. Visit the remote dispensing site at least monthly to conduct controlled substance inventory, to ensure written policies and procedures are being followed, and to ensure that remote dispensing site personnel comply with all federal and state laws regulating the practice of pharmacy.

4. Retain documentation of the monthly inspection visits at the remote dispensing site for 2 years.

(b) The managing pharmacist at the supervising pharmacy is responsible for all remote dispensing sites connected to the supervising pharmacy.

(7)   Requirements for pharmacy technicians and interns. Pharmacy technicians and interns employed at a remote dispensing site shall satisfy all of the following requirements:

(a) Be 18 years of age or older.

(b) Be a high school graduate or have equivalent education.

(c) Have completed 1500 hours of work as a technician within the 3 years prior to the date of employment at the remote dispensing site or completed a training program approved by the board.

CR 09-099 : cr. Register March 2010 No. 651 , eff. 4-1-10.