Click on the pharmacy that pertains to you for more information and application instructions. Please note that all pharmacies applying for a permit must fill out the DEA Controlled Substance Waiver if facility does not perform activities requiring controlled substances.
IN-STATE PHARMACY
IN-STATE PHARMACY
NON-RESIDENT PHARMACY
NUCLEAR PHARMACY
INSTITUTIONAL PHARMACY
PHARMACY SERVICES
IN-STATE PHARMACY
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§ 34-23-30. Pharmacy permits generally.
§ 34-23-30. Pharmacy permits generally.
- Every pharmacy, hospital pharmacy, drugstore, pharmacy department, prescription department, prescription laboratory, dispensary, apothecary or any other establishment with a title implying the sale, offering for sale, compounding or dispensing of drugs in this state, or any person performing pharmacy services in this state, shall register biennially and receive a permit from the Board of Pharmacy.
- Any person desiring to open, operate, maintain, or establish a pharmacy or perform pharmacy services in this state shall apply to the board for a permit at least 30 days prior to the opening of the business. No pharmacy or entity performing pharmacy services shall open for the transaction of business until it has been registered, inspected, and a permit issued by the board.
- The application for a permit shall be made on a form prescribed and furnished by the board which when properly executed shall indicate the ownership desiring such permit and the names and license numbers of all licensed pharmacists employed as well as the location of the pharmacy or entity where pharmacy services are performed and other information as the board may require.
- If more than one pharmacy or entity where pharmacy services are performed is operated by the same owner, a separate application for registration shall be made and a separate permit issued for each such establishment.
- All permits issued under this section shall become due on October 31 and shall become null and void on December 31 of even-numbered years.
- Every application for a permit for a new pharmacy or entity where pharmacy services are performed shall be accompanied by a fee to be determined by the board, but the fee shall not be less than one hundred dollars ($100) nor more than two hundred dollars ($200). Every application for a renewal permit shall be accompanied by a fee to be determined by the board, but the fee shall no be less than fifty dollars ($50) nor more than one hundred fifty dollars ($150). Every application for a permit due to transfer of ownership shall be accompanied by a fee to be determined by the board, but the fee shall not be less than fifty dollars ($50) nor more than one hundred fifty dollars ($150).
- Each application for the renewal of a permit shall be made on or before October 31 of each even-numbered year, at which time the previous permit shall become null and void on December 31 of even-numbered years. A penalty of twenty-five dollars ($25) for each overdue month shall be assessed in addition to the permit fee for renewal of delinquent permits. The secretary of the board shall issue a permit for each pharmacy or entity where pharmacy services are performed whose application is found to be satisfactory by the board. Permits issued under this section shall not be transferable.
- Any change in the control of ownership or licensed pharmacists shall be reported to the board in writing within 10 days of such occurrence. If the pharmacy or entity where pharmacy services are performed is owned by a corporation, the permit shall be issued in the name of the corporation. It shall be the duty of the owners of pharmacies or the owners of entities where pharmacy services are performed who are not licensed pharmacists to immediately notify the board upon the termination of employment of licensed pharmacists and to cause the surrender of permits as indicated. The further operation of the pharmacy or entity where pharmacy services are performed in the absence of licensed pharmacists is forbidden; provided, that the nonregistered owner shall have a period of 30 days within which to comply with this provision. The next of kin of any deceased licensed pharmacist owner shall have a period of 30 days within which to comply with the provisions of this chapter, during which time no prescriptions shall be filled unless a licensed pharmacist is on
NON-RESIDENT PHARMACY
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680-X-2-.07.
680-X-2-.07.
- Registration. No nonresident pharmacy shall ship, mail or deliver prescription drugs and/or devices to a patient in this state unless registered by the Alabama State Board of Pharmacy.
- Agent of Record. Each nonresident pharmacy that ships, mails, or delivers prescription drugs and/or devices to a patient in the State of Alabama shall designate a resident agent in Alabama for service of process. Any such nonresident pharmacy that does not so designate a registered agent and that ships, mails or delivers prescription drugs and/or devices in the State of Alabama shall be deemed an appointment by such nonresident pharmacy of the Secretary of State to be its true and lawful attorney upon whom may be served all legal process in any action or proceedings against such pharmacy growing out of or arising from such delivery. A copy of any such service of process shall be mailed to the nonresident pharmacy by the complaining party by certified mail, return receipt requested, postage prepaid, at the address of such nonresident pharmacy as designated on the pharmacy's application for registration in this state. If any such pharmacy is not licensed in this state, service on the Secretary of State of Alabama only shall be sufficient service.
- Conditions of Registration. As conditions of receiving a permit, the Nonresident Pharmacy or a renewal if applicable must comply with the following:
- Be registered and in a good standing in the state in which such pharmacy is located;
- Maintain, in readily retrievable form, records of legend drugs and/or devices dispensed to Alabama patients;
- Supply upon request, all information needed by the Alabama Board of Pharmacy to carry out the Board's responsibilities under the statutes and regulations pertaining to nonresident pharmacies;
- Maintain pharmacy hours that permit the timely dispensing of drugs to Alabama patients and provide reasonable access for the Alabama patients to consult with a licensed pharmacist about such patients' medications.
- Provide toll-free telephone communication consultation between an Alabama patient and a pharmacist at the pharmacy who has access to the patient's records, and ensure that said telephone number(s) will be placed upon the label affixed to each legend drug container.
- Designate a supervising pharmacist who shall be licensed by the Alabama State Board of Pharmacy. The supervising pharmacist shall be responsible for ensuring that the holder of the permit referenced herein complies with the requirements of this rule and all applicable statutory provisions and rules. If there is a change of the designated Supervising Pharmacist, the permit holder shall notify the Board by filing the "Notice of Change of Supervising Pharmacist" form provided by the Board. If the permit holder is unable to maintain a designated supervising pharmacist, the permit holder shall notify the Board within ten (10) days with an action plan to designate another pharmacist as supervising pharmacist. A permit holder without a designated supervising pharmacist after the ninety (90) day action plan has expired may contact the Board for additional time.
- Compliance. Each nonresident pharmacy shall comply with the following:
- All statutory and regulatory requirements of the State of Alabama for controlled substances, including those that are different from federal law or regulation.
- All the statutory and regulatory requirements of the State of Alabama regarding drug product selection laws.
- Labeling of all prescriptions dispensed, to include but not limited to identification of the product and quantity dispensed.
- All the statutory and regulatory requirements of the State of Alabama for the dispensing of prescriptions in accordance with the quantities indicated by the prescriber.
- Policy and Procedure Manual. Each nonresident pharmacy shall develop and provide the resident board of pharmacy with a policy and procedure manual that sets forth:
- Normal delivery protocols and times;
- The procedure to be followed if the patient's medication is not available at the nonresident pharmacy, or if delivery will be delayed beyond the normal delivery time;
- The procedure to be followed upon receipt of a prescription for an acute illness, which policy shall include a procedure for delivery of the medication to the patient from the nonresident pharmacy at the earliest possible time (i.e. courier delivery), or an alternative that assures the patient the opportunity to obtain the medication at the earliest possible time;
- The procedure to be followed when the nonresident pharmacy is advised that the patient's medication has not been received within the normal delivery time and that the patient is out of medication and requires interim dosage until mailed prescription drugs become available.
NUCLEAR PHARMACY (either in-state or non-resident)
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680-X-2-.20. NUCLEAR PHARMACY. Purpose and Scope: It is unlawful to receive, possess or transfer radioactive drugs, except in accordance with appropriate pharmacy statute(s) and rule(s). It is also unlawful for any person to provide radiopharmaceutical services unless he/she is a pharmacist or a person acting under the direct supervision of a pharmacist acting in accordance with appropriate pharmacy statute(s) and the State Board of Pharmacy rule(s) and rules of the State Board of Health relating to radiation control. No person may receive, acquire, possess, use, transfer or dispose of any radioactive materials except in accordance with the conditions of a radioactive materials license issued by the State Board of Health. The requirements of these Nuclear Pharmacy Regulations are in addition to, and not in substitution for, other applicable provisions of regulations of the State Board of Pharmacy and the State Board of Health.
Definitions: For the purpose of this rule, the following words and phrases pertaining to the practice of nuclear pharmacy shall have the respective meanings ascribed by this action:
Registration and Certification of Pharmacies: The application for a certificate to operate a nuclear pharmacy shall only be issued to a pharmacy registered by the Alabama State Board of Pharmacy and to a licensed, certified nuclear pharmacist. Re-certification shall be biennially which shall expire on December 31 of even- numbered years on forms provided by the Board. Each nuclear pharmacy shall designate a licensed, certified nuclear pharmacist as the Supervising Pharmacist.
Registration and Certification of Pharmacists: All pharmacists engaged in the practice of nuclear pharmacy shall have training or shall have demonstrated previous training in the safe handling of radioactive pharmaceuticals. They must be registered with and certified by the Alabama State Board of Pharmacy. Applications and re-certification with the Board is required biennially which shall expire on December 31 of even- numbered years on forms provided by the Board. Satisfactory completion of no less than two (2) hours of continuing education prior to re-certification earned in the previous calendar year related to nuclear pharmacy shall be required.
General requirements: A licensed, certified nuclear pharmacist shall personally supervise the operation of only one nuclear pharmacy during all times the radiopharmaceutical services are being performed.
The immediate inner container label of a radiopharmaceutical to be distributed shall also be labeled with:
Minimum Requirement for Space,Equipment,Supplies, and Publication:In order to insure compliance with general safety requirements as set forth above, the following minimum requirements shall be met by a nuclear pharmacy, which operates pursuant to a permit issued by the Alabama Board of Pharmacy, and engages in providing radiopharmaceutical services. These requirements are in addition to the minimum requirements for space, equipment and supplies for other types of pharmacies, and those requirements of the State of Alabama Department of Public Health, Radiological Health Branch, for the control of radiation. Such minimum permit requirements are set forth as follows:
Space - The area for the storage, compounding, distribution and disposal of radio pharmaceuticals shall be adequate to completely separate such nonradioactive pharmaceuticals from pharmacy areas.
Equipment:
Supplies:
Training Qualifications: A pharmacist licensed to practice pharmacy in this state, who performs a radiopharmaceutical service, shall, prior to engaging in such specialized practice, meet the minimum training requirements of didactic study, training and experience in the handling of radioactive material.
680-X-2-.20. NUCLEAR PHARMACY. Purpose and Scope: It is unlawful to receive, possess or transfer radioactive drugs, except in accordance with appropriate pharmacy statute(s) and rule(s). It is also unlawful for any person to provide radiopharmaceutical services unless he/she is a pharmacist or a person acting under the direct supervision of a pharmacist acting in accordance with appropriate pharmacy statute(s) and the State Board of Pharmacy rule(s) and rules of the State Board of Health relating to radiation control. No person may receive, acquire, possess, use, transfer or dispose of any radioactive materials except in accordance with the conditions of a radioactive materials license issued by the State Board of Health. The requirements of these Nuclear Pharmacy Regulations are in addition to, and not in substitution for, other applicable provisions of regulations of the State Board of Pharmacy and the State Board of Health.
Definitions: For the purpose of this rule, the following words and phrases pertaining to the practice of nuclear pharmacy shall have the respective meanings ascribed by this action:
- Nuclear Pharmacy - A pharmacy which provides a radiopharmaceutical service.
- Nuclear Pharmacist - An actively licensed pharmacist who has met the training qualifications as described in the rule.
- Radiopharmaceutical Service - Shall include, but shall not be limited to, the procurement, storage, preparation, labeling, quality assurance testing, distribution, record keeping or disposal of radiopharmaceuticals.
- Radiopharmaceutical - Any substance defined as a drug in Code of Alabama 1975, §34-23-1(11) which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium containing salts which contain trace quantities of naturally occurring radionuclides.
- Radiopharmaceutical Quality Assurance - Includes, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals, and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.
- Authentication of Product History-Includes,but is not limited to,identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical or other drug.
Registration and Certification of Pharmacies: The application for a certificate to operate a nuclear pharmacy shall only be issued to a pharmacy registered by the Alabama State Board of Pharmacy and to a licensed, certified nuclear pharmacist. Re-certification shall be biennially which shall expire on December 31 of even- numbered years on forms provided by the Board. Each nuclear pharmacy shall designate a licensed, certified nuclear pharmacist as the Supervising Pharmacist.
Registration and Certification of Pharmacists: All pharmacists engaged in the practice of nuclear pharmacy shall have training or shall have demonstrated previous training in the safe handling of radioactive pharmaceuticals. They must be registered with and certified by the Alabama State Board of Pharmacy. Applications and re-certification with the Board is required biennially which shall expire on December 31 of even- numbered years on forms provided by the Board. Satisfactory completion of no less than two (2) hours of continuing education prior to re-certification earned in the previous calendar year related to nuclear pharmacy shall be required.
General requirements: A licensed, certified nuclear pharmacist shall personally supervise the operation of only one nuclear pharmacy during all times the radiopharmaceutical services are being performed.
- The nuclear pharmacy area shall be secured from access by unauthorized personnel.
- Each nuclear pharmacist shall maintain accurate records of the acquisition, inventory, distribution, and disposal of all radiopharmaceuticals.
- All nuclear pharmacies shall provide a secure radioactive storage and decay area.
- All nuclear pharmacies shall comply with all applicable laws and regulations of federal and state agencies for the procurement, secure storage, inventory, preparation, distribution and disposal of radiopharmaceuticals and other drugs.
- Radiopharmaceuticals are to be dispensed only upon a prescription or medication order, from a licensed medical practitioner or his/her authorized agent authorized to possess, use and administer radiopharmaceuticals.
- A nuclear pharmacist may transfer radioactive materials to an*authorized user in accordance with all applicable laws and regulations.
- A nuclear pharmacy, upon receiving an oral order for a radiopharmaceutical, shall immediately have the order reduced to writing or recorded in a data processing system which writing or records shall contain at least the following:
- The name of the authorized user or his/her agent.
- The date of distribution and the time of calibration of the radiopharmaceutical.
- The name of the procedure.
- The name of the radiopharmaceutical.
- The dose or quantity of the radiopharmaceutical.
- The prescription number assigned to the order for the radiopharmaceutical.
- Any specific instructions.
- The initials of the person dispensing the radiopharmaceutical.
- Whenever an order is for a therapeutic or blood-product radiopharmaceutical, the patient's name must be obtained and recorded. In addition to other labeling requirements of the state laws and rules of the Board of Pharmacy for nonradioactive pharmaceuticals
- The standard radiation symbol.
- The words, "Caution Radioactive Material".
- The name of the procedure.
- The prescription number of the radiopharmaceutical and a suitable lot number for traceability.
- The radionuclide and chemical form.
- The amount of radioactivity and the calibration date and time.
- The expiration date and time.
- The volume dispensed if liquid chemical form.
- The number of items or weight if solid chemical form.
- The number of ampules or vials if gaseous chemical form.
- Molybdenum-99 content to USP limits.
- The name of the patient, or the words, "Physician's Use Only", in the absence of a patient name.
The immediate inner container label of a radiopharmaceutical to be distributed shall also be labeled with:
- The standard radiation symbol.
- The words, "Caution Radioactive Material".
- The radionuclide.
- The chemical form.
- The name of the procedure.
- The prescription number of the radiopharmaceutical.
Minimum Requirement for Space,Equipment,Supplies, and Publication:In order to insure compliance with general safety requirements as set forth above, the following minimum requirements shall be met by a nuclear pharmacy, which operates pursuant to a permit issued by the Alabama Board of Pharmacy, and engages in providing radiopharmaceutical services. These requirements are in addition to the minimum requirements for space, equipment and supplies for other types of pharmacies, and those requirements of the State of Alabama Department of Public Health, Radiological Health Branch, for the control of radiation. Such minimum permit requirements are set forth as follows:
Space - The area for the storage, compounding, distribution and disposal of radio pharmaceuticals shall be adequate to completely separate such nonradioactive pharmaceuticals from pharmacy areas.
Equipment:
- Fume hood
- Shielded radiation containment drawing section
- Dose calibrator
- Well scintillation counters
- Area rate meters
- Geiger-Mueller (GM) survey meters
- Refrigerator
- Microscope
- Hemocytometer
- Leaded glass syringe and vial shields
- Personnel radiation detection devices
- Radioactive storage container and/or storage vault for waste materials
Supplies:
- Syringes and vials required to perform practice
- Disposable gloves and protective lab coats
- Appropriate supplies to ensure aseptic technique
- Appropriate supplies to perform thin layer chromatography
- Lead transport shields for syringes and vials
- D.O.T. Type 7A approved transport containers and other labels and supplies for shipping radioactive materials.
Training Qualifications: A pharmacist licensed to practice pharmacy in this state, who performs a radiopharmaceutical service, shall, prior to engaging in such specialized practice, meet the minimum training requirements of didactic study, training and experience in the handling of radioactive material.
- A licensed pharmacist seeking to practice nuclear pharmacy in this state, shall submit to the Board of Pharmacy, a certificate of training and a course outline from an accredited college of pharmacy, or other program recognized by the State of Alabama Department of Public Health, Radiological Health Branch and the Alabama Board of Pharmacy, and a certificate of such training which provides a minimum of 200 clock hours of formal didactic training. To satisfy the basic instruction requirement, 200 hours of classroom and laboratory training shall include:
- Radiation physics and instrumentation
- Radiation Protection
- Mathematics pertaining to the use and measurement of radioactivity
- Radiation Biology
- Radiopharmaceutical chemistry
- The minimum on-the-job training which shall be included in a radio pharmacy internship is five hundred (500) hours of training and experience in the handling of unsealed radioactive material under the supervision of a licensed nuclear pharmacist. The training and experience shall include, but shall not be limited to the following:
- Ordering, receiving and unpackaging radioactive material safely, including performing related radiation surveys.
- Calibrating dose calibrators, scintillation detectors, and radiation monitoring equipment.
- Calculating, preparing and verifying patient doses while maintaining radiation safety standards of shielding.
- Following appropriate internal control procedures to prevent mislabeling.
- Learning emergency procedures to handle and contain spilled materials safely, including related decontamination procedures and surveys.
- Eluting Technetium-99 from generator systems, assaying the eluate for technetium-99m, for molybdenum-99 contamination, and processing the eluate with reagent radio pharmaceuticals.
- Clinical practice concepts.
INSTITUTIONAL PHARMACIES
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680-X-2-.18. INSTITUTIONAL PHARMACIES.
APPLICABILITY: In addition to existing State and Federal Regulations, the following Rules are applicable to all Institutions and Institutional Pharmacies as defined in Section 2 below.
DEFINITIONS.
"Institutional Facility" means any organization whose primary purpose is to provide a physical environment for inpatients to obtain health care services, including but not limited to a:
"InstitutionalPharmacy"means that physical portion of an Institutional Facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease (hereinafter referred to as "Drugs"); and which is registered with the State Board of Pharmacy.
PERSONNEL:
Each Institutional Pharmacy shall be directed by a pharmacist, hereinafter referred to as the Supervising Pharmacist, who is licensed to engage in the practice of pharmacy in this State.
ABSENCE OF PHARMACIST:
680-X-2-.18. INSTITUTIONAL PHARMACIES.
APPLICABILITY: In addition to existing State and Federal Regulations, the following Rules are applicable to all Institutions and Institutional Pharmacies as defined in Section 2 below.
DEFINITIONS.
"Institutional Facility" means any organization whose primary purpose is to provide a physical environment for inpatients to obtain health care services, including but not limited to a:
- Hospital
- Convalescent Home
- Nursing Home
- Extended Care Facility
- Mental Health Facility
- Rehabilitation Center
- Psychiatric Center
- Developmental Disability Center
- Drug Abuse Treatment Center
- Family Planning Clinic
- Penal Institution
- Hospice
- Public Health Facility
- Athletic Facility.
"InstitutionalPharmacy"means that physical portion of an Institutional Facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease (hereinafter referred to as "Drugs"); and which is registered with the State Board of Pharmacy.
PERSONNEL:
Each Institutional Pharmacy shall be directed by a pharmacist, hereinafter referred to as the Supervising Pharmacist, who is licensed to engage in the practice of pharmacy in this State.
ABSENCE OF PHARMACIST:
- During such times as 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 Institutional Facility by use of a locked 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.
- In the absence of a pharmacist, Drugs shall be stored in a cabinet/enclosure constructed and located outside of the Pharmacy area, to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons. The Supervising Pharmacist shall, in conjunction with the appropriate committee of the Institutional Facility, develop inventory listings of those Drugs to be included in such cabinet/enclosure and determine who may have access, and shall ensure that:
- The Drugs are properly labeled;
- Only prepackaged Drugs are available, in amounts sufficient for immediate therapeutic requirements;
- Whenever access to the cabinet/enclosure occurs, written orders of an authorized practitioner and proofs of use are provided;
- All drugs therein are inventoried regularly based on institutional policy, but no less than every thirty (30) days;
- A complete audit of all activity concerning such cabinet/enclosure is conducted no less than once per month;
- Written policies and procedures are established to implement the requirements of this Section 4.
- Whenever any Drug is not available from floor supplies or cabinet/enclosure, 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 4. 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 Institutional 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, room number, name of Drug, strength, amount, date, and time and signature of designee. The form shall be left with the container from which the drug was removed.
- For an Institutional Facility that does not have an Institutional Pharmacy, Drugs may be provided for use by authorized personnel by emergency kits located at such Facility, provided, however, such kits meet the following requirements:
- The contents of the Emergency kit shall consist of those Drugs needed to effectively manage a critical care incident or need of a patient. 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.
- All emergency kit drugs shall be provided and sealed by a pharmacist who is licensed to engage int he practice of pharmacy in this state;
- The supplying pharmacist and the medical staff of the Institutional Facility shall jointly determine the Drugs, by identity and quantity, to be included in emergency kits;
- Emergency kits shall be stored in secured areas to prevent unauthorized access, and to ensure a proper environment for preservation of the Drugs within them;
- The exterior of 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;
- Drugs shall be removed from emergency kits only pursuant to a valid written order of an authorized practitioner;
- Whenever an emergency kit is opened,the supplying pharmacist shall be notified and the pharmacist shall stock and reseal the kit within a reasonable time but not more than 72 hours, so as to prevent risk of harm to patients; and
- 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.
- For an institutional Facility that does not have an institutional pharmacy, Drugs may be stored in a cabinet/enclosure to which only authorized personnel may obtain access by key, combination, or access code and which is sufficiently secure to deny access to unauthorized persons, provided, however , such cabinet/enclosure meet the following requirements:
- Definition of Stat Cabinet - A Stat Cabinet 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 patient by delay resulting from attaining such Drugs from other sources.
- Each facility may maintain one “stat” cabinet/enclosure 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” cabinet/enclosure, it must be approved by the Alabama State Board of Health and the Alabama State Board of Pharmacy.
- All medications shall be packaged in an appropriate manner in the “stat” cabinet based on the established needs of the facility. Need for such medications shall be reviewed by the pharmacist annually.
- 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” cabinet shall be properly labeled with name, strength and expiration date.
- There shall be records available to show amount received, name of resident and amount used, prescribing physician, time of administration, name of individual removing and using the medication and the balance on hand.
- There shall be written procedures for utilization of the “stat” cabinet with provisions for prompt replacement of used items.
- The pharmacist shall inspect the “stat” cabinet at least monthly replacing outdated Drugs and reconciliation of its prior usage. Information obtained shall be included in a monthly report.
PHARMACY SERVICES
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PHARMACY SERVICES PERMIT. Certain services performed by a pharmacy, as defined by board rule, and specifically excluding, the receipt or inventory of drugs, medicines, chemicals, poisons, or medical devices. This subdivision, and any rule promulgated by the board pursuant to this subdivision, may not be interpreted to expand the practice of pharmacy as the practice of pharmacy and permits are limited by this section and Sections 34-23-11 and 34-23-70, or to restrict the practice of medicine as defined in Section 34-24-50.
This subdivision, and any rule promulgated by the board pursuant to this subdivision, is subject to the restrictions contained in subsection (b) of Section 34-23-30.
This subdivision shall not be interpreted to allow the board to promulgate any rule that would authorize a pharmacist to sell, offer for sale, or dispense any prescription drug except pursuant to the terms of a valid prescription issued by a licensed practitioner authorized to prescribe such drug.
680-X-2-.41 PHARMACY SERVICES PERMITS.
PHARMACY SERVICES PERMIT. Certain services performed by a pharmacy, as defined by board rule, and specifically excluding, the receipt or inventory of drugs, medicines, chemicals, poisons, or medical devices. This subdivision, and any rule promulgated by the board pursuant to this subdivision, may not be interpreted to expand the practice of pharmacy as the practice of pharmacy and permits are limited by this section and Sections 34-23-11 and 34-23-70, or to restrict the practice of medicine as defined in Section 34-24-50.
This subdivision, and any rule promulgated by the board pursuant to this subdivision, is subject to the restrictions contained in subsection (b) of Section 34-23-30.
This subdivision shall not be interpreted to allow the board to promulgate any rule that would authorize a pharmacist to sell, offer for sale, or dispense any prescription drug except pursuant to the terms of a valid prescription issued by a licensed practitioner authorized to prescribe such drug.
680-X-2-.41 PHARMACY SERVICES PERMITS.
- The Board may issue on a case by case basis a Pharmacy Service Permit for the limited purpose of allowing pharmacists and pharmacy technicians to provide pharmacy services to patients and clients. Nothing in this rule shall limit the board’s ability to issue any Pharmacy Service Permit the Board deems appropriate.
- The Board has determined that, at a minimum, the holder of a Pharmacy Service Permit must designate a Supervising Pharmacist who shall be licensed by the Alabama State Board of Pharmacy, on site, who is responsible for ensuring that the processes and compliance standards are maintained within limits set by the Board for the permit holder.
- Nothing in this rule restricts the Board from setting pharmacist and technician ratios.
- Nothing in this rule shall authorize any individual to perform any activity beyond their scope of practice pursuant to any license or registration issued to them.
- In the event the application for a Pharmacy Services Permit is by a non-resident pharmacy, in addition to the requirements set out in Paragraphs (1) through (4) above, if applicable, the applicant must comply with to the following requirements:
- Complete an application furnished by the Board and be issued the referenced permit. Any application which is not full and complete will not be processed.
- Pay the fee set out in Code of Alabama, (1975) §34-23-30.
- The Pharmacy Services Permit issued by the Board shall become void on December 31st of even numbered years unless renewed in compliance with Code of Alabama, (1975) §34-23-30.
- Submit documentation from the applicant’s home state verifying any applicable license or permit is valid and in good standing.
- Designate a resident agent in Alabama for service of process. The failure to include this information shall result in the denial of the application.
- In the event the applicant will be involved or participate in any remote order processing and not actually shipping, mailing or delivering any drug from its location to a citizen in this State, there shall also be compliance with the following:
- All statutory and regulatory requirements of the State of Alabama relating to controlled substances, including those that are different from federal law or regulation.
- All the statutory and regulatory requirements of the State of Alabama regarding drug product selection laws.
- All Board of Pharmacy requirements for data submission related to volumes of orders processed as specified at the time of approval.
- Submission with the application a policy and procedure manual for Board approval which must, at a minimum, include the following:
- Hours of operation.
- On-Call Pharmacist. For the protection of patients, when orders are being processed remotely and no pharmacist is onsite at the resident Pharmacy, a pharmacists must be on-call to respond to situations that arise that cannot be addressed through remote services, such as patient needing a specific medication which is not available until the resident Pharmacy opens, or a healthcare provider urgently needing information that cannot be provided by the pharmacists performing remote order processing.
- Procedures to be following in case of downtime.
- The system to be used to identify and respond to medication errors arising from mistakes from remote order processing.
- The system to be used to insure initial and ongoing quality of remote order processing.
- The means by which compliance with HIPAA requirements will be met.
- Designate a supervising pharmacist who shall be responsible for ensuring compliance with this rule and all applicable laws and rules.
- Compliance with any other requirement deemed necessary by the Board, to include but not limited to required technician to pharmacist ratios.