al-al-6a2c5dc37f9e2059cceacbab: 680-X-2-.18 — Institutional Pharmacies
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What this rule does
The proposed amendment to the rule for institutional pharmacies aims to expand the provisions for dispensing medications in settings like hospitals and healthcare facilities. It requires pharmacies operating in these environments to obtain a permit from the Alabama State Board of Pharmacy and establishes specific procedures for the safe distribution of medications.
Plain-language description generated by AI — not the agency’s official summary, which we have not captured for this rule. Read the official text →
The rule, in full
4,580 words as published, August 31, 2026. View the original →
APA-1 TRANSMITTAL SHEET FOR NOTICE OF INTENDED ACTION Control: 680 Department or Agency: Alabama State Board of Pharmacy Rule No.: 680-X-2-.18 Rule Title: Institutional Pharmacies Intended Action Amend Would the absence of the proposed rule significantly harm or endanger the public health, welfare, or safety? Yes Is there a reasonable relationship between the state’s police Yes power and the protection of the public health, safety, or welfare? Is there another, less restrictive method of regulation available No that could adequately protect the public? Does the proposed rule have the effect of directly or indirectly Yes increasing the costs of any goods or services involved? To what degree?: Slight. See fiscal note. Is the increase in cost more harmful to the public than the harm that might result from the absence of the proposed rule? No Are all facets of the rule-making process designed solely for the purpose of, and so they have, as their primary effect, the Yes protection of the public? Does the proposed action relate to or affect in any manner any litigation which the agency is a party to concerning the subject No matter of the proposed rule? Does the proposed rule have an economic impact? Yes If the proposed rule has an economic impact, the proposed rule is required to be accompanied by a fiscal note prepared in accordance with subsection (f) of Section 41-22-23, Code of Alabama 1975. Certification of Authorized Official I certify that the attached proposed rule has been proposed in full compliance with the requirements of Chapter 22, Title 41, Code of Alabama 1975, and that it conforms to all applicable filing requirements of the Administrative Procedure Division of the Legislative Services Agency. Signature of certifying officer Jon M Linna Jon Linna REC’D & FILED Date Wednesday, August 19, 2026 AUG 19, 2026 LEGISLATIVE SVC AGENCY APA-2 ALABAMA STATE BOARD OF PHARMACY NOTICE OF INTENDED ACTION AGENCY NAME: Alabama State Board of Pharmacy RULE NO. & TITLE: 680-X-2-.18 Institutional Pharmacies INTENDED ACTION: Amend SUBSTANCE OF PROPOSED ACTION: This Rule amendment is proposed to expand the provisions of dispensing medications in an institutional pharmacy setting. TIME, PLACE AND MANNER OF PRESENTING VIEWS: The public hearing will be October 21, 2026 during the business meeting beginning at 9:00 am CST at the Board of Pharmacy office, located at 111 Village Street, Birmingham, AL 35242. Comments may be submitted to Anne Marie Nolen via email to anolen@albop.com by EOB October 20, 2026. FINAL DATE FOR COMMENT AND COMPLETION OF NOTICE: Tuesday, October 20, 2026 CONTACT PERSON AT AGENCY: Anne Marie Nolen anolen@albop.com Jon M Linna Jon Linna (Signature of officer authorized to promulgate and adopt rules or his or her deputy) 680-X-2-.18 Institutional Pharmacies. (1) Definitions (a) "Automated dispensing system" means an electromechanical system that performs operations or activities related to the storage and dispensing of medications and can collect, control, and maintain required transaction information and records. (b) " Emergency dispensingDispensing" is defined as prescribing/ providing necessary medications to patients being treated by institutional facilities within the physical institutional facility or to be taken with the patient upon discharge. (c) "Emergency kit" is a kit consisting of drugs, including controlled substances, needed to effectively manage a critical care incident or need of a patient. (d) "Licensed healthcare facility" means a hospital, as defined in Code of Ala. 1975, §22—21—20(1) licensed by the Alabama Department of Public Health. (e) "Managing pharmacy" means a pharmacy responsible for supplying prescribed medications for patients in a licensed healthcare facility and the safe operation of any automated dispensing system used in the facility. A managing pharmacy may be one of the following:
1. A pharmacy physically located in Alabama, not within a
licensed healthcare facility, holding a current pharmacy permit issued by the Alabama Board of Pharmacy
2. An institutional pharmacy serving as the managing
pharmacy for a facility operating as a department of the licensed healthcare facility upon approval by the Board. (f) "Stat medicine cabinet" is a cabinet or enclosure that consists of non—controlled drugs needed to effectively manage a patient's drug regimen which are not available from any other authorized source in sufficient time to prevent risk of harm to patients. (g) "Positive identification" means the method by which access to the medications and information contained in an automated dispensing system in a licensed healthcare facility is limited to only authorized individuals, and which includes the use of a user—specific password combined with a user— 2-.18-1 specific personal identifier such as a fingerprint, personal ID badge, retinal pattern, or other unique identifier. (2) Drug Distribution and Control in Institutional Pharmacies (a) The following locations shall obtain an institutional pharmacy permit from the Board:
3. A pharmacy that is not a physical portion of a
licensed healthcare facility but provides centralized services to an institutional pharmacy;
4. A pharmacy providing services for patients who receive
care through an integrated correctional health care system (b) The supervising pharmacist shall establish written procedures for the safe and efficient distribution of drugs and for the provision of institutional pharmacy services. A current updated copy of such procedures shall be on hand for inspection by the Board of Pharmacy. (c) All of the activities and operations of each institutional pharmacy shall be personally and directly supervised by its supervising pharmacist or a designated pharmacist. (d) When patients bring drugs into a licensed healthcare facility, such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant to a practitioner's order only. If such drugs are not to be administered, they shall be given to an adult member of the patient's immediate family for removal from the facility, or follow written policy provided by the supervising pharmacist. (e) Investigational drugs for inpatient use shall be stored in and dispensed from the pharmacy only. Complete information on all investigational drugs stored or dispensed shall be maintained in the pharmacy. (f) The supervising pharmacist shall develop a recall procedure that can be readily implemented to assure the medical and pharmacy staff of the licensed healthcare facility that all drugs included on the recall intended for 2-.18-2 use within the facility are returned to the pharmacy for proper disposal. (3) Stat Medicine Cabinets (a) During such times an institutional pharmacy may be unattended by a pharmacist, arrangements shall be made in advance by the supervising pharmacist for provision of drugs to the medical staff and other authorized personnel of the licensed healthcare facility by use of a stat medicine cabinet or other enclosure constructed and located outside of the pharmacy area and, in emergency circumstances, by access to the pharmacy. A pharmacist shall be available after hours in accordance with established institutional policy. (b) In licensed healthcare facilities utilizing a managing pharmacy, drugs shall be stored in a stat medicine cabinet to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons, provided, however, such cabinet meets the following requirements:
1. Each facility may maintain one stat medicine cabinet
for the purpose of keeping a minimum amount of stock medications that may be needed quickly or after regular duty hours. If a facility wants more than one stat medicine cabinet, it must be approved by the Alabama State Board of Health pursuant to Chapter 420-5-10.
2. All medications shall be packaged in an appropriate
manner in the stat medicine cabinet based on the established needs of the facility. Need for such medications shall be reviewed by the pharmacist annually.
3. There must be a list of contents, approved by the
appropriate committee and a pharmacist, giving the name and strength of the drug and the quantity of each. Contents of the stat medicine cabinet shall be properly labeled with name, strength, and expiration date.
4. There shall be records available to show amount
received, name of patient and amount used, prescribing physician, time of administration, name of individual removing and using the medication, and the balance on hand.
5. There shall be written procedures for utilization of
the stat medicine cabinet with provisions for prompt replacement of used items. 2-.18-3
6. The pharmacist shall inspect the stat medicine cabinet
at least monthly replacing outdated drugs and reconciliation of its prior usage. Information obtained shall be included in a monthly report. (c) The supervising pharmacist of either the institutional pharmacy or the managing pharmacy shall, in conjunction with the appropriate committee of the licensed healthcare facility, develop inventory listings of those drugs to be included in a stat medicine cabinet, determine who may have access, and have written policies and procedures to ensure that:
2. Only prepackaged drugs are available, in amounts
sufficient for immediate therapeutic requirements;
3. Whenever access to the cabinet occurs, written orders
of an authorized practitioner and proofs of use are provided;
4. All drugs therein are inventoried regularly based on
institutional policy, but no less than every thirty (30) days;
5. A complete audit of all activity concerning such
cabinet is conducted no less than once per month. (d) Whenever any drug is not available from floor supplies or cabinet, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy in accordance with the requirements of this Section 3. One supervisory nurse or physician in any given shift is responsible for obtaining drugs from the pharmacy. The responsible person shall be designated in writing by the appropriate committee of the licensed healthcare facility. Removal of any drug from the pharmacy by an authorized designee must be pursuant to written orders of an authorized practitioner and must be recorded on a suitable form showing patient name, patient date of birth, room number, name of drug, strength, amount, date, time, and signature of designee. The form shall be left with the container from which the drug was removed. (4) Emergency Kits (a) Drugs may also be provided in a licensed healthcare facility for use by authorized personnel by emergency kits 2-.18-4 located at such facility, provided, however, such kits meet the following requirements:
1. A copy of the list of the contents of the emergency
kit shall be maintained both at the institution and the pharmacy supplying the drugs;
2. All emergency kit drugs shall be provided and sealed
by a pharmacist who is licensed to engage in the practice of pharmacy in this state;
3. The supplying pharmacist and the medical staff of the
licensed healthcare facility shall jointly determine the drugs, by identity and quantity, to be included in emergency kits;
4. Emergency kits shall be securely stored in areas to
prevent unauthorized access, and to ensure a proper environment for preservation of the drugs within them;
5. Each emergency kit shall be labeled so as to clearly
indicate that it is an emergency drug kit and that it is for use in emergencies only. The label shall contain a listing of the drugs contained in the kit, including name, strength, quantity, and expiration date of the contents, and the name, address(es) and telephone number(s) of the supplying pharmacist;
6. Drugs shall be removed from emergency kits only
pursuant to a valid order of an authorized practitioner;
7. Whenever an emergency kit is opened, the supplying
pharmacist shall be notified, and the pharmacist shall stock and reseal the kit within not more than 72 hours, so as to prevent risk of harm to patients; and
8. The expiration date of an emergency kit shall be the
earliest date of expiration of any drugs supplied in the kit. Upon the occurrence of the expiration date, the supplying pharmacist shall replace the expired drug. (5) Automated Dispensing Systems (a) Automated dispensing systems may be used to meet the needs of patients in licensed healthcare facilities. The automated dispensing system must be located in a licensed healthcare facility that either:
2. Holds a valid and current contract with a Managing
Pharmacy to provide pharmacy services to that facility. The automated dispensing system shall be considered an extension of the managing pharmacy. (b) General requirements for automated dispensing systems include:
1. The supervising pharmacist of either the facility or
managing pharmacy is responsible for the operation of the automated dispensing system. A pharmacist of either the facility or managing pharmacy must always have access to the equipment and all transaction information.
2. Access to the drugs and information contained within
the automated dispensing system is secured through the use of positive identification.
3. Access to the automated dispensing system shall be
controlled by the pharmacy and shall be limited to: i. Licensed nurses ii. Licensed pharmacists iii. Registered pharmacy technicians iv. Respiratory therapy v. Other licensed healthcare professionals as approved by the supervising pharmacist or medical staff vi. Authorized field service personnel for maintenance purposes and only while under direct observation of a licensed nurse, a licensed pharmacist, or a registered pharmacy technician.
4. If the automated dispensing system is managed by a
managing pharmacy, medications delivered to the licensed healthcare facility but not yet stocked into the automated dispensing system are stored in a secure manner and in compliance with the policies and procedures agreed upon by the pharmacy and the leadership of the facility.
5. Restocking of the automated dispensing system shall be
limited to a licensed pharmacist or a registered pharmacy technician of either the facility or managing pharmacy, a licensed nurse of the facility, or other licensed healthcare personnel approved by the Board of Pharmacy. 2-.18-6
6. If the facility is utilizing a managing pharmacy, a
pharmacist of the managing pharmacy shall conduct an on— site physical inventory of the contents of the automated dispensing system at least quarterly.
7. A pharmacist employed by either the facility or
managing pharmacy reviews, interprets, and approves all prescription medication orders prior to removal of a drug from the automated dispensing system. When a medication is ordered and needed but the order has not been reviewed, interpreted, and approved by the pharmacist, emergency access to the medication by authorized users is allowed if such access is permitted by written policies and procedures agreed upon by the pharmacy and appropriate leadership of the facility.
8. The name and quantity of medications and products kept
in the automated dispensing system shall be agreed upon by the pharmacy, the facility's Medical Director, and appropriate nursing leadership of the facility. (c) Nothing in this rule shall be interpreted to amend, alter, or modify the provisions of Alabama Code Section 34, Chapter 23 or supporting regulations. (6) Dispensing For Institutional Facilities (a) Institutional pharmacies may dispense the following medications upon discharge pursuant to a prescription authorized by a practitioner with proper prescribing authority:
1. Bulk medications for single patient use that have been
opened or partially used during the patient's hospitalization;
4. Any other non-controlled medication deemed essential
to the maintenance of life or the continuation of therapy if, in the pharmacist's professional judgement, the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort, provided that: 2-.18-7 i. the medication cannot be reasonably obtained through normal outpatient pharmacy services within the timeframe required for safe and effective treatment; and ii. the dispensing occurs within three (3) calendar days following discharge; and iii. the pharmacy dispenses no more than a four (4) day supply or combination of smallest available package size; and iv. the dispensing occurs in accordance with institutional policy (b) Requirements for emergency dispensing labeling must include, but is not limited to:
5. Total quantity dispensed
5. Any additional information that is a true statement of fact may be included as deemed essential for proper storage, handling, safety, and/or usage of the prescription. (b) Emergency dispensing may be utilized for the following medications(c) Records of all medications dispensed pursuant to this subsection shall be maintained by the institutional pharmacy for a minimum of two (2) years and shall be readily retrievable for inspection by the Board. Such records shall include, at a minimum:
2. Medications deemed necessary with Board
approvalMedication name, strength, dosage form, and quantity dispensed;
6. Documentation of the pharmacist’s professional
determination that the criteria of subsection (6)(a)(4) were met. (7) Centralized Services (a) The purpose of this Rule is to provide standards for an institutional pharmacy to perform Centralized Services. (b) An institutional pharmacy may perform the following centralized services:
4. Perform off-site order entry in compliance with
requirements of the Pharmacy Practice Act and any other applicable state and federal statutes and regulations
5. Additional functions as approved by the Board
(c) The pharmacies must notify the Board before utilizing centralized services. (d) Regardless of whether located within or outside this State, the following requirements apply to any pharmacy involved in centralized services:
2. The pharmacies must either:
i. be owned by the same person or entity; or ii. have 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; and iii. share a common electronic file or have appropriate technology to allow access to sufficient information necessary to process medication orders 2-.18-9
3. The institutional pharmacy performing centralized
services shall maintain a record of all pharmacies, including name, address, and DEA number to which services are provided.
4. The pharmacies and all pharmacy personnel must comply
with all provisions of the Pharmacy Practice Act, and all other State and federal statutes, rules, and regulations. (e) The pharmacies utilizing centralized services shall maintain a policy and procedure manual which includes the following:
1. appropriate records to identify the responsible
pharmacists in performing centralized services;
3. description of adequate security to protect the
integrity and prevent the illegal use or disclosure of protected health information;
4. description of drug storage and security in compliance
with all applicable federal and state statutory and regulatory requirements;
6. documented annual review.
Author: Alabama State Board of Pharmacy Statutory Authority: Code of Ala. 1975, §34-23-74. History: Filed November 6, 1987; effective January 1, 1988. Amended: July 6, 1993; effective January 1, 1994. Amended: Filed August 6, 1993. Amended: Filed February 13, 1997; effective March 20, 1997. Amended: Filed September 20, 1999; effective October 25, 1999. Amended: Filed April 3, 2003; effective May 8, 2003. Amended: Filed September 22, 2009; effective October 27, 2009. Amended: Filed January 30, 2012; effective March 5, 2012. Amended: Filed April 14, 2015; effective May 19, 2015. Amended: Filed June 8, 2016; effective July 23, 2016. Amended: Filed August 23, 2019, effective October 7, 2019. Amended: Published September 30, 2022; effective November 14, 2022. Repealed and New Rule: Published September 29, 2023, effective November 13, 2023. Amended: Published July 31, 2025; effective September 14, 2025. Amended: Published ______; effective ______. 2-.18-10 APA-6 ECONOMIC IMPACT STATEMENT FOR APA RULE (Section 41-22-23(f)) Control No: 680 Department or Agency: Alabama State Board of Pharmacy Rule No: 680-X-2-.18 Rule Title: Institutional Pharmacies Intended Action: Amend This rule has no economic impact. Yes This rule has an economic impact, as explained below:
1. NEED/EXPECTED BENEFIT OF RULE:
The Alabama State Board of Pharmacy proposes to amend Rule 680-X-2-.18 (Institutional Pharmacies) to: (1) replace the defined term “emergency dispensing” with the broader term “dispensing”; (2) clarify and modestly relax the Board’s rules regulating the categories of medications an institutional pharmacy may dispense to a patient upon discharge — including bulk medications partially used during hospitalization, rescue medications such as naloxone, epinephrine, and glucagon, antiretroviral post-exposure prophylaxis, and other non- controlled medications the pharmacist determines are essential to the maintenance of life or continuity of therapy — subject to conditions limiting such dispensing to within two calendar days of discharge and to a four-day supply or the smallest available package size; (3) revise and clarify labeling requirements for such dispensing, including an express requirement to state the total quantity dispensed; and (4) add specific recordkeeping requirements (patient name, medication and dispensing details, prescriber, authorizing pharmacist, and the pharmacist’s documented determination of necessity), to be retained for at least two years and available for Board inspection. The amendment applies only to institutional pharmacies already permitted by the Board and does not alter the Pharmacy Practice Act or the Board’s existing licensing and inspection framework. The amendment is needed to address stakeholder concerns presented to the Board about the dispensing limitations imposed by the current rule. In response to these stakeholder concerns, the Board proposes to give institutional pharmacies clear authorization, with defined guardrails, to send patients home with a short supply of medications needed to avoid a gap in therapy or an immediate health risk (for example, overdose-reversal or infection-prevention medications) when APA-6 those medications cannot reasonably be obtained through normal community pharmacy channels sufficiently quickly. The expected benefits are improved continuity of care and patient safety at the point of hospital discharge, along with clearer compliance standards for institutional pharmacies and more consistent records for Board inspection.
2. COSTS/BENEFITS OF RULE AND WHY RULES IS THE MOST EFFECTIVE, EFFICIENT,
AND FEASIBLE MEANS FOR ALLOCATING RESOURCES AND ACHIEVING THE STATED PURPOSE: The rule imposes only minor administrative costs on the institutional and managing pharmacies it governs — chiefly updating internal policies and modest additions to recordkeeping that build on documentation those pharmacies already maintain. It does not require new equipment, staffing, licensure, or fees. The anticipated benefits — safer, better-documented discharge dispensing — are expected to greatly outweigh these limited costs. Because the amendment operates through the Board’s existing permitting and inspection framework and simply clarifies and modestly expands existing dispensing authority, it is the most cost-effective, efficient, and feasible means of achieving the stated purpose. Leaving the current rule unchanged would arguably perpetuate over-restrictive regulation without offsetting cost savings.
3. EFFECT OF THIS RULE ON COMPETITION:
No effect on competition is anticipated. The amendment applies uniformly to all institutional pharmacies and managing pharmacies holding a Board permit; it does not create new categories of licensure, favor any pharmacy, health system, or vendor, or otherwise alter the competitive landscape among pharmacies or healthcare facilities in Alabama.
4. EFFECT OF THIS RULE ON COST-OF-LIVING AND DOING BUSINESS IN THE
GEOGRAPHICAL AREA WHERE THE RULE IS TO BE IMPLEMENTED: No material effect on the costs of living and of doing business in Alabama are anticipated. The entities affected are already licensed institutional pharmacies operating within hospitals; the amendment does not impose new permit fees, equipment requirements, or staffing mandates. Any incremental cost of updating policies and records is minor, one-time in large part, and not expected to be passed on to patients or otherwise affect the cost of living or of doing business in any geographic area of the state.
5. EFFECT OF THIS RULE ON EMPLOYMENT IN THE GEOGRAPHICAL AREA WHERE THE
RULE IS TO BE IMPLEMENTED: No effect on employment is anticipated. The amendment does not require additional pharmacist, technician, or other staff, and existing APA-6 staffing levels at licensed healthcare facilities are expected to be fully sufficient to carry out the expanded dispensing and recordkeeping provisions.
6. SOURCE OF REVENUE TO BE USED FOR IMPLEMENTING AND ENFORCING THIS RULE:
No additional revenue for implementation or enforcement is required. The amendment does not create a new fee, permit, or program. Implementation and enforcement will occur through updates to institutional pharmacy policies, the Board’s existing licensing, inspection, and compliance functions, funded through existing permit fees and appropriations, without need for additional revenue.
7. THE SHORT-TERM/LONG-TERM ECONOMIC IMPACT OF THIS RULE ON EFFECTED
PERSONS, INCLUDING ANALYSIS OF PERSONS WHO WILL BEAR THE COSTS AND THOSE WHO WILL BENEFIT FROM THE RULE: In the short term, affected institutional and managing pharmacies may incur slight, largely one-time costs to revise policies and procedures and train staff on the updated discharge-dispensing, labeling, and recordkeeping provisions. In the long term, no material economic impact is anticipated; ongoing compliance costs are minimal because comparable recordkeeping is already required under the existing rule and the Pharmacy Practice Act. The slight costs of the rule are borne by licensed institutional and managing pharmacies in the form of modest administrative and compliance effort. The benefits accrue directly to patients discharged from licensed healthcare facilities, who gain clearer, more reliable access to medications needed to avoid an interruption in therapy or an immediate health risk, and indirectly to the public, through reduced risk of adverse health events following discharge.
8. UNCERTAINTIES ASSOCIATED WITH THE ESTIMATED BENEFITS AND BURDENS OF
THE RULE, INCLUDING QUALITATIVE/QUANTITATIVE BENEFITS AND BURDEN COMPARISON: The principal uncertainty is in quantifying the qualitative patient- safety benefit of clearer discharge-dispensing authority (for example, reduced risk of overdose or care interruption) against the modest, largely quantifiable compliance costs borne by pharmacies. Data isolating the incremental effect of this rule change, as distinct from other clinical and policy factors affecting discharge outcomes, is not available and is not likely econometrically measurable. Having considered both the qualitative and quantitative benefits and burdens, the Board has determined that the qualitative patient-safety benefits are reasonably expected to outweigh the minimal quantifiable burdens, and that the rule is needed notwithstanding this uncertainty. APA-6
9. THE EFFECT OF THIS RULE ON THE ENVIRONMENT AND PUBLIC HEALTH:
No effect on the environment (e.g., wildlife and clean soil, air, and water) is anticipated. A positive effect on public health is expected: clearer and modestly expanded authority to dispense rescue medications (such as naloxone, epinephrine, and glucagon) and post-exposure prophylaxis at discharge, paired with defined quantity and timing limits and enhanced recordkeeping, is expected to reduce the risk of care interruption and improve documentation supporting patient safety. The proposed rule, if adopted, may also tend to decrease re-admissions which may sometimes occur when patients are not able to readily obtain important medicines upon discharge.
10. DETRIMENTAL EFFECT ON THE ENVIRONMENT AND PUBLIC HEALTH IF THE RULE IS
NOT IMPLEMENTED: If the amendment is not adopted, the current rule’s narrower and less clearly defined discharge-dispensing categories, labeling requirements, and recordkeeping provisions would remain in effect. Expressed stakeholder concerns regarding the restrictiveness of the current rule would go unaddressed. This could leave continued ambiguity as to institutional pharmacies’ authority to provide certain rescue or continuation-of-therapy medications at discharge, potentially resulting in delayed patient access to needed medications in some cases, without any offsetting economic, environmental, or public-health benefit from forgoing the amendment. Signature of certifying officer Jon M Linna Jon Linna Date Wednesday, August 19, 2026
Rulemaking docket
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Documents
- Full text (state register) · August 31, 2026
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