Ala. Admin. Code r. 680-X-2-.30

Current through Register Vol. 42, No. 8, May 31, 2024

Section 680-X-2-.30 - Central Prescription Filling

(1) Purpose. The purpose of this section is to provide standards for centralized prescription filling by a pharmacy.

(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.

(a) ACT. The Alabama Pharmacy Practice Act, Code of Ala. 1975, § 34-23-1, et seq. and the Alabama Uniform Controlled Substances Act, Code of Ala. 1975, § 20-2-1, et seq.

(b) CENTRAL PRESCRIPTION FILLING. The filling of a new or refilling of a prescription drug order by one pharmacy licensed by the Alabama State Board of Pharmacy at the request of another pharmacy licensed by the Alabama State Board of Pharmacy for delivery to the patient or patient's agent, pursuant to the lawful order of a practitioner.

(c) DISPENSE. To sell, distribute, administer, leave with, give away, dispose of, deliver, or supply a drug or medicine to the ultimate user or their agent.

(3) Operational standards.

(a) General requirements.

1. A pharmacy may outsource a prescription drug order filling to another pharmacy provided the pharmacies:

(i) Have the same owner; or

(ii) Have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and

(iii) Share a common electronic file or have appropriate technology or interface to allow access to sufficient information necessary or required to fill or process a prescription drug order.

2. The supervising pharmacist of the filling pharmacy shall assure that:

(i) The pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperate range to maintain the integrity of the medication throughout the delivery process; and

(ii) The filled prescriptions are shipped in containers, which are sealed in a manner as to show evidence of opening or tampering.

(iii) The filling pharmacy shall comply with the provisions of the Act.

3. Any filled prescription, which was not picked up, must be put into the dispensing pharmacy's inventory.

4. No licensed pharmacist or central fill pharmacy operating within this state shall accept for refund purposes or otherwise any unused portion of any filled prescription.

5. Schedule I & II drugs may not be centrally filled.

(4) The Board shall approve based on a presentation before the Board any pharmacy(ies) who intend on utilizing central prescription filling.

(5) Notification to patients. A pharmacy that outsources prescription filling to another pharmacy shall:

(a) Prior to outsourcing their prescription:

1. Notify patients that their prescription may be outsourced to another pharmacy:

2. Give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may fill the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of the sign in the pharmacy.

(6) Prescription Labeling. The filling pharmacy shall:

(a) Place on the prescription label a 'Unique Identifier' of the pharmacy filling the prescription and name and address of the pharmacy that dispenses the filled prescription.

(b) Indicate in some manner which pharmacy filled the prescription (e.g., "Filled by ABC Pharmacy for XYZ Pharmacy"); and

(c) Comply with all other labeling requirements of federal and state statutes or Rules.

(7) Records:

(a) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

1. The records maintained in the alternative system contain all the information required on the annual record; and

2. Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions filled or dispensed by the pharmacy.

3. The dispensing pharmacy shall maintain records which indicate the date:

(i) The request for filling was transmitted to the filling pharmacy; and

(ii) The filled prescription was received by the dispensing pharmacy and the name of the person accepting delivery.

4. The filling pharmacy shall maintain records which:

(i) Track the prescription drug order during each step in the filling process and identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any portion of the process including, transmission, filling, dispensing, or delivery; and

(I) Records which indicate;

(II) The date the prescription was shipped to the dispensing pharmacy;

(III) The name and address where the prescription was shipped; and

(IV) The method of delivery (e.g., private, common, or contract carrier).

(8) Policies and Procedures. A policy and procedure manual as it relates to centralized filing shall be maintained at both the filling and dispensing pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:

(a) Outline the responsibilities of each of the filling and dispensing pharmacies;

(b) Include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription filling; and

(c) Include policies and procedures for:

1. Notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription filling and the name of that pharmacy;

2. Protecting the confidentiality and integrity of patient information;

3. Dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;

4. Complying with federal and state laws and Rules;

5. Operating a continuous quality improvement 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, and resolve identified problems.

6. Annually reviewing the written policies and procedures and documenting such review.

Ala. Admin. Code r. 680-X-2-.30

New Rule: Filed February 13, 2003; effective March 20, 2003.

Amended by Alabama Administrative Monthly Volume XXXVII, Issue No. 09, June 28, 2019, eff. 8/4/2019.

Author: James S. Ward, Board Attorney

Statutory Authority:Code of Ala. 1975, § 34-23-92.