Automated Filling Systems within a Pharmacy

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.608Automated Filling Systems within a Pharmacy

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 133, July 11, 2017 issue of the Florida Administrative Register.

The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and discussion and subsequent vote by the board at the public meeting held August 15, 2017. The rule shall now read as follows:

64B16-28.608 Automated Filling Systems within a Pharmacy.

(1) Definitions. The following definitions shall be applicable for purposes of this rule:

(a) through (e) No change.

(f) “System drug identifier database” means the database or other system which positively identifies the drug to be dispensed by the automated filling system.

(2) through (4) No change.

(5) The pharmacist verification requirements of subsection (4) shall be deemed satisfied if:

(a) through (d) No change.

(e) A pharmacist verifies the correct medication, either the Manufacturer Unit of Use Package, Repacked, or Prepacked container, was properly stocked, filled and stocked in the system. Alternatively, an electronic verification process may be used to verify a Manufacturer Unit of Use Package, repackaged, or prepacked containers;

(f) through (h) No change.

(6) The pharmacist verification requirements of subsection (4) shall be deemed satisfied for a system that is not fully automated when all or part of the system is used for Manufacturer Unit of Use Packages if:

(a) No change.

(b) The Electronic Verification Process activities are undertaken by a pharmacist, pharmacy intern, or registered pharmacy technician under the supervision of a pharmacist, as each are defined by subsection 64B16-27.1001(7), F.A.C. and consistent with Section 64B16-27.4001, F.A.C; and

(c) No change.

(7) Policies and Procedures. Pharmacies verifying prescriptions pursuant to subsections (5) or (6) of this rule shall establish and follow written policies and procedures to ensure the proper, safe, and secure functioning of the system. Policies and procedures shall be reviewed annually by the prescription department manager or consultant pharmacist of record and shall be maintained in the pharmacy’s records for a minimum of four (4) years. The required annual review shall be documented in the pharmacy’s records and made available upon request. At a minimum, the pharmacy shall establish and follow policies and procedures for:

(a) No change.

(b) Ensuring the integrity of the system drug identifier identity database and identification of persons responsible for database entries;

(c)(b) Ensuring accurate filling stocking, and verification of the system, as applicable;

(d) through (l) No change.

(8) No change.

Rulemaking Authority 465.005, 465.0155, 465.022(1), FS. Law Implemented 465.003(17), 465.0155, 465.022(1), FS. History‒New 3-24-14,        .

 

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254.