reglab/statecodes huggingface dataset:
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.02 - Examination Grades

Current through Register Vol. 42, No. 9, June 28, 2024
On examinations administered by the board for licensure to
				practice pharmacy in the State of Alabama, each applicant shall be required to
				obtain at least 75 on any Alabama prepared practical examination, covering
				state and federal law combined with an oral interview, and a general average of
				75 on all National Boards of Pharmacy examinations.
Author:
Jerry Moore, Executive
				Secretary
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.03 - Sources Of Information

Current through Register Vol. 42, No. 9, June 28, 2024
The secretary is instructed not to reveal the source of any
				information which may be given to him to any member of the Board, or to the
				state drug investigators, with respect to any violations of law, except in or
				to a court of justice.
Author:
James W. McLane
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.04 - Prescription Department Technical Equipment

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Every pharmacy licensed in this state
			 shall have on hand the following technical equipment; the last edition and/or
			 revision of "Facts and Comparison" or any reference book or electronic media
			 sufficient to meet the level of its pharmacy practice; and hot and cold running
			 water in the prescription area.
(2)
			 Every satellite pharmacy of licensed institutional pharmacies shall have all of
			 the above. In addition, community pharmacies shall have on hand an exempt
			 narcotic register.
(3) In addition,
			 all pharmacies shall have on hand any technical equipment commensurate with its
			 level and type of practice, i.e., hoods for I.V. preparations.
Author:
Donna C. Yeatman, R.Ph., Executive
				  Secretary
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.05 - Prescription Files

Current through Register Vol. 42, No. 9, June 28, 2024
In order to facilitate the inspection of records, each
				prescription on file must bear the initials of the person who compounded and/or
				dispensed it, as well as the number of the prescription and the date it was
				dispensed.
Author:
James W. McLane
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.06 - Absence Of Licensed Pharmacist Supervising An Assistant

Current through Register Vol. 42, No. 9, June 28, 2024
In the event a licensed pharmacist who is supervising an
				assistant has left the premises, a sign shall be posted in a prominent place on
				the prescription counter, easily viewed by the public, giving the pharmacist's
				name, the hours he will be away from the premises, and the address and
				telephone number where he can be reached; or if an alternative supervising
				pharmacist is being used, the sign shall give that pharmacist's name, address,
				and telephone number where he can be reached. The supervising pharmacist must
				be able to return to the store premises within a reasonable period of time. The
				State Board of Pharmacy defines reasonable in this context to mean no longer
				than 30 minutes following a request for his appearance.
Author:
James W. McLane
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.09 - Training For Preceptors

Current through Register Vol. 42, No. 9, June 28, 2024
In accordance with Section
				34-23-73, Title 34, Chapter 23,
Code of Ala. 1975
, in order to be approved as a
				preceptor, a Pharmacist must have been licensed to practice pharmacy for a
				minimum of two (2) years and complete an initial two (2) hour board approved
				preceptor training program. All Pharmacists who have been approved by the
				Alabama State Board of Pharmacy as Preceptors must complete a two (2) hour
				training seminar for preceptors each renewal cycle or be approved by the School
				of Pharmacy for curriculum hours. Such training seminar shall have prior
				approval of the Board.
Author:
Donna C. Yeatman, R.Ph., Executive
				  Secretary
Statutory Authority:
Code of Ala.
				  1985
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.10 - Reporting Place Of Employment, Interns And Externs

Current through Register Vol. 42, No. 9, June 28, 2024
In accordance with §27(a) of Code of Ala. 1940, Recompiled
				1958, as amended in 1966, all pharmacy candidates who are working either as
				interns or externs shall report their place of employment to the Alabama State
				Board of Pharmacy within 10 days of such employment, and any change in such
				employment shall be reported to the Alabama State Board of Pharmacy within 10
				days of such change.
Author:
James W. McLane
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.11 - Pharmacy Keys Or Other Controlled Access Device Or Method

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Any pharmacy
			 doing business within the State of Alabama must be physically enclosed, secured
			 and locked when not open for business, except in the temporary absence of the
			 pharmacist on duty as provided for in §
								34-23-70(a).
			 Title 34, Chapter 23,
Code of Ala. 1975
. At all times,
			 registered Pharmacists designated by the licensee must have all keys or other
			 controlled access device or method in their possession. The owner of the
			 pharmacy may designate one (1) unregistered person to have a key or other
			 controlled access device or method to the pharmacy and still be considered to
			 be in their possession. The Supervising Pharmacist must agree to this
			 arrangement. The enclosed and secured area must encompass all drugs, products,
			 and devices, the character of which require dispensing or sale by a registered
			 Pharmacist, and include store rooms used for receiving or storing these items.
			 The permit holder (owner) must execute a signed agreement with the individual
			 in possession of a key or other controlled access device or method to the
			 pharmacy and must submit a copy to the Board of Pharmacy for approval prior to
			 issuing a key or other controlled access device or method to any person that
			 does not hold an active pharmacist license in the State of Alabama. Forms for
			 this purpose may be obtained from the Board of Pharmacy. Further, if the
			 municipality or other government authority in the jurisdiction where a pharmacy
			 is located requires compliance with a Fire Code that mandates making a key or
			 other controlled access device or method to the premises available to First
			 Responders, the permit holder (owner) must execute a signed agreement with the
			 highest ranking official of the agency that wants access to the key or other
			 controlled access device or method and submit a copy of the Board of Pharmacy
			 for approval prior to providing access to a key or other controlled access
			 device or method; the Knox Box or other system for accessing the key or other
			 controlled access device or method must have a working tamper protection system
			 that is connected to an alarm system that will notify the permit holder (owner)
			 or the Supervising Pharmacist if an attempt is made to remove the key or other
			 controlled access device or method by unauthorized persons.
(2) Where the Pharmacist does not have access
			 to the prescription department by other entrances after normal operating hours
			 of the entire store the owner shall have an action plan that allows the
			 pharmacist to gain access in case of an emergency.
Author:
Herb Hobo, R.Ph., Secretary
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.13 - Prescription Labels

Current through Register Vol. 42, No. 9, June 28, 2024
In addition to existing state and federal regulations, the
				label of every prescription dispensed in this state shall bear as a minimum,
				the name and address of the pharmacy from which the prescription was dispensed,
				the prescriber's directions for use, the name of the drug as it is dispensed,
				and the strength per dosage unit. When the prescription is a manufacturer's
				mixture of ingredients or one with a common given name, only the name of the
				mixture need be indicated. However, in the absence of a name, the term
				"prescriber's mixture" may be used when the list of ingredients contained
				therein exceed what can be reasonably included on the prescription label. 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. The drug name and strength per dosage unit may be excluded from
				the label at the request of the prescribing physician. The prescriber's
				directions for use may be excluded on prescription labels for hospital
				in-patients. The institutional name shall not be required on individual unit
				dose units or floor stock medication which is controlled with proof-of-use
				sheets.
Author:
James W. McLane
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.14 - The Role Of Technicians In Pharmacie

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Title 34, Chapter 23,
Code of
			 Ala. 1975
, specifies that only persons licensed by the Board of
			 Pharmacy may practice pharmacy. The practice of pharmacy shall mean the
			 interpretation and evaluation of prescription orders; the compounding,
			 dispensing, administering and labeling of drugs and devices; the participation
			 in drug selection and drug utilization reviews and drug therapy management; the
			 proper and safe storage of drugs and devices and the maintenance of proper
			 records; the responsibility for advising, where necessary or where regulated,
			 of therapeutic values, content, hazards and use of drugs and devices; and the
			 offering or performing of those acts, services, operations or transactions
			 necessary in the conduct, operation, management and control of
			 pharmacy.
(2) The only other
			 persons who may perform the above tasks other than a licensed pharmacist, and
			 then only under the immediate direct supervision of a pharmacist, are the
			 following:
(a) A person serving an internship
			 who holds a professional degree in pharmacy from a school of pharmacy
			 recognized by the Board.
(b) A
			 person serving an externship who is enrolled in a school of pharmacy recognized
			 by the Board.
(c) A person who hold
			 an assistant's license.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.15 - Use Of Computers For Recordkeeping In Pharmacies In Alabama

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Title 34,
			 Chapter 23,
Code of Ala. 1975,
specifies the power and
			 duty of the Board to adopt rules concerning the records and reports to be kept
			 and made by a pharmacy.
(a) The computerized
			 system shall provide for the storage and retrieval of original prescription
			 orders as follows:
1. The original
			 prescription number.
2. The
			 prescribing practitioner's name.
3.
			 Full name and address of the patient.
4. Date the original prescription was issued
			 and the date it was dispensed, if different from the date of issue.
5. Name, strength, dosage form, and quantity
			 of drug dispensed.
6. Total number
			 of refills authorized by the prescriber.
7. Quantity dispensed.
8. In the case of controlled substance, the
			 DEA registration number and the Alabama controlled substances number of the
			 prescribing practitioner.
9.
			 Identification of the dispensing pharmacist.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.17 - Reciprocity

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The Board may
			 issue a license without examination to an applicant who furnishes satisfactory
			 proof that he/she has been licensed to practice pharmacy by examination in
			 another state that under like conditions grants reciprocal licensure without
			 examination to pharmacists duly licensed by examination in this
			 state.
(2) The application must be
			 accompanied by a fee of $300.00.
Author:
Jerry Moore, R. Ph., Executive
				Secretary
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.18 - Institutional Pharmacies

Current through Register Vol. 42, No. 9, June 28, 2024
(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 dispensing"
			 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) "Institutional pharmacy" means a physical
			 portion of a licensed healthcare facility that is engaged in the compounding,
			 dispensing, and distribution of drugs, devices, and other materials and the
			 provision of services used in the prevention, diagnosis, and treatment of
			 injury, illness, and disease (hereafter referred to as "institutional pharmacy
			 services") and which is permitted with the Alabama State Board of
			 Pharmacy.
(e) "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, or a Federally Qualified
			 Health Center, as defined by ALA. ADMIN. CODE r.
			 560-X-48-.01(1).
(f) "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.
(g) "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.
(h) "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- specific personal identifier such as a
			 fingerprint, personal ID badge, retinal pattern, or other unique
			 identifier.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.19 - Parenteral Sterile Therapy

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
			 Purpose: Whereas the Alabama State Board of Pharmacy is charged with the duty
			 and responsibility to control the compounding and distribution of prescription
			 drug products in the State of Alabama, and is further charged to protect the
			 citizens from inferior drug products and inappropriate compounding procedures.
			 This rule shall provide guidelines and regulations for the compounding and
			 distributing of parenteral products in Alabama, and to assure the Alabama
			 consumer of sterile parenteral products that are dispensed or prepared by
			 qualified pharmacists using acceptable pharmaceutical techniques and
			 equipment.
(2) Registration and
			 Certification, Pharmacies: All pharmacies engaged in the compounding of
			 products which should be sterile shall be registered with the Alabama State
			 Board of Pharmacy biennially which shall expire on December 31 of even-numbered
			 years and Alabama pharmacies shall receive a permit in accordance with
Code of Ala. 1975
, §
								34-23-30. Such pharmacies shall be
			 certified, further, by the Alabama State Board of Pharmacy as a parenteral
			 sterile compounding pharmacy.
(3)
			 Registration and Certification, Pharmacists: All pharmacists, permitted and
			 practicing in Alabama, engaged in compounding and dispensing of product which
			 should be sterile, including cytotoxic agents, shall register each renewal
			 cycle with the Board of Pharmacy in accordance with
Code of Ala.
			 1975
, §§
								34-23-51,
			 34-23-52. After January 1, 1994,
			 pharmacists who have not successfully completed a certifying course for sterile
			 compounding approved by the Board, will not be registered as sterile
			 compounding pharmacists until they have completed said certifying course.
			 Programs submitted for certification shall be a minimum of eight (8) contact
			 hours, including didactic and hands on experience. All programs certified by
			 the Board shall require a written exam as a part of the training. Pharmacists
			 performing high risk sterile compounding shall complete an additional four (4)
			 hour board approved high risk program. All pharmacists approved by the Alabama
			 State Board of Pharmacy as sterile compounding pharmacists must successfully
			 complete two (2) continuing education hours approved by the Board including
			 didactic and hands on training each renewal cycle.
(4) It shall be the responsibility of the
			 supervising pharmacist to verify the parenteral certification of pharmacists
			 involved in the preparation of parenteral products.
Author:
Donna C. Yeatman, R.Ph., Executive
				  Secretary
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.20 - Nuclear Pharmacy

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
			 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 pharmacy 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.
(2) 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:
(a) Nuclear Pharmacy - A pharmacy which
			 provides a radiopharmaceutical service.
(b) Nuclear Pharmacist - An actively licensed
			 pharmacist who has met the training qualifications as described in the
			 rule.
(c) Radiopharmaceutical
			 Service - Shall include, but shall not be limited to, the procurement, storage,
			 preparation, labeling, quality assurance testing, distribution, recordkeeping
			 or disposal of radiopharmaceuticals.
(d) Radiopharmaceutical - Any substance
			 defined as a drug in
Code of Ala. 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.
(e)
			 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.
(f) 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.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.21 - Patient Counseling

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
			 Pharmacists, because of their strategic position in the health care system,
			 have traditionally provided drug information to their patients and to other
			 health care professionals. In the best interest of the public health, the
			 patient must be offered counseling for all new prescriptions and, where
			 appropriate, for refill prescriptions. The offer to counsel shall be made by
			 the pharmacist or the pharmacist's designee in a face to face oral
			 communication with the patient or the patient's representative, unless in the
			 professional judgment of the pharmacist, it is deemed inappropriate or
			 unnecessary. If it is deemed inappropriate or unnecessary by the pharmacist, it
			 would be permissible for the offer to counsel to be made in a written
			 communication, by telephone, or in a manner determined by the pharmacist to be
			 appropriate. Said counseling must be performed by the pharmacist or properly
			 supervised pharmacist intern. A printed statement shall be included with every
			 prescription listing the pharmacy's telephone number, for the patient to call
			 with questions about their medication.
(2) Each new prescription and, where
			 appropriate, refill prescription, should be reviewed for, but not limited to,
			 the following:
(a) therapeutic
			 duplication;
(b) drug-disease
			 contraindication where indicated;
(c) drug-drug interaction;
(d) incorrect dosage/duration;
(e) drug allergy interactions; and
(f) clinical abuse/misuse.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.24 - Precursor Drugs

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Listed
			 Precursor Chemicals:
(a) All substances
			 listed as precursor chemicals in any regulation set forth in the Code of
			 Federal Regulations shall be considered and designated as a precursor chemical
			 with the exception of those precursor chemicals designated or deleted as such
			 under federal law to which the Board objects, after notice, in the manner
			 provided in
Code of Ala. 1975
, §
									20-2-181(c), all
			 precursor chemicals listed in any federal regulation shall be considered and
			 designated as precursor chemicals pursuant to the provisions of
Code of Ala. 1975
, §
									20-2-180, et seq. (2)
			 License.
(a) Beginning in 2011 and
			 every two years thereafter, any individual, corporation, partnership,
			 association or other entity who is a manufacturer, wholesaler, retailer or
			 other person who sells, transfers, manufactures, purchases for resale or
			 otherwise furnishes any listed precursor chemicals as defined or designated by
			 any federal or state law or rule must obtain a license. The license shall be
			 issued only after the filing of an application with the Alabama State Board of
			 Pharmacy and Board approval. The application shall contain information as
			 required by and in conformity with any applicable federal or state law or
			 rule.
(b) A biennial license fee in
			 the amount of $500.00 shall be paid by all licensees to the Alabama State Board
			 of Pharmacy by December 31 of any even numbered year. If any holder of such a
			 license fails to pay the renewal fee on or before the due date, the license may
			 be reinstated only upon payment of a penalty of ten dollars ($10) for each
			 lapsed month as prescribed by rule of the board.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.25 - Drug Manufacturers; Wholesale Drug Distributors; Private Label Distributors, Repackager, Third Party Logistics, 503B Outsourcer; Reverse Distributor Permit Fees. Retail Medical Oxygen. (Repealed)

Current through Register Vol. 42, No. 9, June 28, 2024
Author:
Donna C. Yeatman, R.Ph., Executive
				  Director
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.26 - Emergency Prescription Refills

Current through Register Vol. 42, No. 9, June 28, 2024
(1) If a pharmacist received a request for a
			 prescription refill, and the pharmacist is unable to readily obtain refill
			 authorization from the prescriber, the pharmacist may dispense a one-time
			 emergency refill of up to a 72-hour supply of the prescribed medication or the
			 smallest dispensable package size if a 72 hour supply is not readily available,
			 under the following conditions:
(a) The
			 prescription is not a medicinal agent listed in Schedule I or II pursuant to
			 Title 20, Chapter 2, or the controlled substance list for Schedule I or II
			 maintained by the State Board of Health.
(b) The medication is essential to the
			 maintenance of life or the continuation of therapy and in the pharmacist's
			 professional judgement, the interruption of therapy might reasonably produce
			 undesirable health consequences or may cause physical or mental
			 discomfort.
(c) The pharmacist has
			 a record of a prescription at the pharmacy or has been presented proof of a
			 prescription filled within the last 90 days in the name of the patient for whom
			 the request of the emergency supply is being made.
(d) A pharmacist or pharmacy shall not
			 dispense or sell the same drug to the same patient, as provided in this
			 section, more than one time in any 12-month period.
(e) The pharmacist must inform the patient or
			 the patient's representative at the time of dispensing that the refill is being
			 provided without the practitioner's authorization, and that practitioner
			 authorization is required for any future refill.
(f) The dispensing pharmacist shall create a
			 written prescription order containing all of the prescription information
			 required by federal and state statutes, rules and regulations and shall also
			 include the statement "Emergency Fill".
(g) The dispensing pharmacist shall notify
			 the prescriber orally or in writing of the emergency dispensing within
			 twenty-four (24) hours after such dispensing.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.27 - Private Consultation Areas For Pharmacies

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Since the implementation of patient
			 consultation requirements as a result of OBRA '90 guidelines, it has become
			 evident that the current setup in pharmacies is not conducive to proper
			 communication with patients by pharmacists. Research shows that private
			 consultation areas will facilitate proper consultation with patients by
			 pharmacists and the resultant patient outcomes will be enhanced. Therefore, in
			 order to protect the health of the public and enhance their medication
			 outcomes, private consultation areas must be furnished by pharmacy
			 owners.
(2) The size of the
			 consultation areas must be large enough to accommodate the participants and
			 must be entirely devoted to enhancing patient outcomes and not a storage room
			 for merchandise or other non-related items. The area must be accessible by the
			 patient from outside of the pharmacy area without having to traverse a stock
			 room or pharmacy area and must have the capability of being private to both
			 sounds and viewing by unauthorized parties. The area must be away from checkout
			 areas and flows of traffic that would present a barrier to patient
			 communication.
(3) All new
			 pharmacies that open after January 1, 1997, must be compliance before a permit
			 is issued. All pharmacies that are relocated after January 1, 1997, shall be in
			 compliance. All existing pharmacies must be in compliance on or before January
			 1, 2005.
Author:
Jerry Moore, R. Ph., Executive
				Secretary
Statutory Authority:
Code of Ala.
				  1975,
§
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.28 - Temporary Absences Of Pharmacists During Break And Meal Period

Current through Register Vol. 42, No. 9, June 28, 2024
(1) This rule is to
			 allow pharmacists to have breaks and meal periods without unreasonably
			 impairing the ability of a pharmacy to remain open.
(2) In any pharmacy that is staffed by a
			 single pharmacist, the pharmacist may leave the pharmacy area or department,
			 temporarily, for breaks and meal periods without closing the pharmacy and
			 removing interns/externs and technicians from the pharmacy, if the pharmacist
			 reasonably believes that the security of the controlled substances will be
			 maintained in his or her absence.
(a) If, in
			 the professional judgment of the pharmacist, the pharmacist determines that the
			 pharmacy should be closed during his or her absence, then the pharmacist shall
			 close the pharmacy area or department and remove all interns/externs and
			 technicians from the pharmacy during his or her absence.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.29 - Score Transfer

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The
			 board may issue a license without an additional North American Pharmacist
			 Licensure Examination (NAPLEX) if, at the time the examination is taken, the
			 applicant designates that the score is to be transferred to Alabama. The
			 applicant is then required to take the Alabama Multi-State Pharmacy
			 Jurisprudence Exam (MPJE), obtain an average of 75 and participate in an oral
			 interview conducted by the Board. He of she shall furnish satisfactory proof
			 that he or she holds a professional degree from a division, school, college or
			 a university department of pharmacy recognized by the State Board of Pharmacy.
			 The state from which the score is being transferred must accept a score
			 transfer from the State of Alabama.
(2) The application must be accompanied by a
			 fee of $300.00.
Author:
Herb Bobo, R.Ph., Secretary
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.30 - Central Prescription Filling

Current through Register Vol. 42, No. 9, June 28, 2024
(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.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.31 - Regulation Of Daily Operating Hours

Current through Register Vol. 42, No. 9, June 28, 2024
Any person who receives a community pharmacy permit pursuant to
				§
								34-23-30, and commences to operate
				such an establishment shall, for the benefit of the public health and welfare,
				keep the prescription department of the establishment open for a minimum of
				twenty (20) hours per week. A pharmacy may apply to the Board for a waiver or
				exception under special circumstances. A representative from the pharmacy may
				be required to appear before the Board in order for this waiver or exception to
				be considered. A sign in block letters not less than one inch in height shall
				be displayed either at the main entrance of the establishment or at or near the
				place where prescriptions are dispensed in a prominent place that is in clear
				and unobstructed view. Such sign shall state the hours the prescription
				department is open each day.
Author:
Kenny Sanders, R.Ph., President
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.32 - Prescriptions By Electronic Means

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The following requirements shall apply to
			 any prescription, as that term is defined in
Code of Ala.
			 1975
, §
								34-23-1(25), for
			 non-controlled legend drugs transmitted by electronic means.
(a) The prescription must include the
			 patient's name and address, the drug prescribed, strength per dosage unit,
			 directions for use, and the name of the prescriber or authorized agent. To the
			 extent not included above, the prescription must comply with any applicable
			 provisions of the Alabama Pharmacy Practice Act or Board Rule now existing or
			 later amended or changed.
(b)
			 Prescriptions may be transmitted directly to the pharmacy or transmitted over
			 an e-prescription network approved by the Board. All such transmissions must
			 ensure appropriate security and authenticity to include the following:
1. An electronic signature process enabling
			 the pharmacy to ensure the identity of the prescriber;
2. Date and time stamp;
3. Transmitting system identifier;
4. Prescriber internal sender identification;
			 and
5. Pharmacy internal receiver
			 identification.
(c) Any
			 pharmacy receiving a prescription shall comply with all requirements for
			 recordkeeping and prescription information mandated by the provisions of the
			 Alabama Pharmacy Practice Act or Board Rule now existing or later
			 amended.
(d) Prescriptions for
			 controlled substances, whether scheduled pursuant to state or federal law shall
			 not be authorized until the Drug Enforcement Agency has adopted applicable
			 regulations, at which time all prescriptions for controlled substances must
			 comply with the provisions of any such regulation or any later amendments or
			 changes thereto.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.33 - Internet Pharmacies

Current through Register Vol. 42, No. 9, June 28, 2024
Before dispensing a prescription, a pharmacist shall make every
				reasonable effort to ensure that any order, regardless of the means of
				transmission, has been issued for a legitimate medical purpose by an authorized
				practitioner and pursuant to a valid patient-practitioner
				relationship.
Author:
James S. Ward, J.D.
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.34 - Fees For Applicants For Pharmacist License AAnd Biennial License Renewal

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The
			 fee for licensure examination shall be $300.00.
(2) The fee for initial registration for
			 licensure shall be $100.00.
(3) The
			 fee for biennial renewal of a pharmacist license will be $100.00 Upon
			 verification of fifty (50) years of licensure in this state the renewal fee
			 shall be no more than twenty-five dollars ($25).
4) All fees required above shall not be
			 refundable.
(5) Penalties for late
			 renewal of a pharmacist license shall be governed by the provisions of the
			 Alabama Pharmacy Practice Act.
Author:
Kenny Sanders, R.Ph., President
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.35 - Fees For Initial Pharmacy Permits, Biennial Permit Renewal, And Transfer Of Ownership

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The
			 application fee for a new pharmacy permit for a resident pharmacy or a resident
			 pharmacy services permit shall be $200.00. The application fee for a new
			 pharmacy permit for a non-resident pharmacy or for a non-resident pharmacy
			 services permit shall be $750.00.
(2) The fee for biennial renewal of a
			 pharmacy or pharmacy services permit shall be $100.00. The fee for biennial
			 renewal of a non-resident pharmacy permit or pharmacy services permit shall be
			 $400.00.
(3) The fee for transfer
			 of ownership of a pharmacy permit shall be $250.00.
(4) All fees required above shall not be
			 refundable.
(5) Penalties for late
			 renewal of a pharmacy permit or pharmacy services permit shall be governed by
			 the provisions of the Alabama Pharmacy Practice Act.
Author:
Susan Alverson, R.Ph., Executive
				  Director
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.38 - Licensure Of Graduates Of Foreign Schools Of Pharmacy

Current through Register Vol. 42, No. 9, June 28, 2024
(1) In addition to complying with all
			 requirements of the Alabama Pharmacy Practice Act relating to licensure, any
			 applicant for pharmacist licensure who is a graduate of a foreign school or
			 college of pharmacy shall comply with the following:
(a) Must successfully obtain and provide to
			 the Board a copy of the Foreign Pharmacy graduate Equivalency Committee
			 Certification.
(b) Must pass a
			 written examination on the laws governing the practice of pharmacy in this
			 state.
(c) Must complete a
			 practical training program as specified in
Code of Ala.
			 1975,
Title 34 Chapter 23, Practice of Pharmacy Act 205, §
									34-23-53 and Board of Pharmacy
			 Rule 680-X-2-.16.
(d) Must demonstrate to the Board the ability
			 to effectively communicate in the English language. In making this assessment,
			 the Board will consider written application materials, oral communication
			 during the interview process and other materials or communications provided by
			 the applicant.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.39 - Pharmacy Off Site Order Entry

Current through Register Vol. 42, No. 9, June 28, 2024
(1) The purpose of this Rule is to provide
			 Alabama standards for remote or off-site order entry in any pharmacy to which a
			 permit has been issued by the Alabama State Board of Pharmacy ("the
			 Board").
(2) Definitions
(a) "Off-site order entry pharmacy" means a
			 pharmacy ("pharmacy") which has a valid permit issued by the Board to process
			 legend and controlled substance prescriptions that remotely accesses another
			 pharmacy's electronic data base from outside the pharmacy in order to process
			 prescription drug orders, provided the pharmacy establishes controls to protect
			 the privacy and security of confidential records.
(b) "Off-site order entry" does not include
			 the dispensing of a prescription drug order but includes any of the following:
1. Interpreting or clarifying prescription
			 drug orders;
2. Data entering and
			 transferring of prescription drug order information;
3. Performing drug regimen review;
4. Obtaining refill and substitution
			 authorizations;
5. Performing
			 therapeutic interventions; and
6.
			 Providing clinical drug information concerning a patient's
			 prescription.
(c) "Drug
			 regimen review" means an evaluation of prescription drug orders and patient
			 profile records for:
1. Known
			 allergies;
2. Rational
			 therapy-contraindications;
3.
			 Reasonable dose and route of administration;
4. Reasonable directions for use;
5. Duplication of therapy;
6. Drug-drug interactions;
7. Drug-food interactions;
8. Proper utilization, including
			 over-utilization or under-utilization.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.40 - Non-Disciplinary Penalty For Late Renewal Of License, Permit, Registration, Certification, Or Any Similar Document Issued

Current through Register Vol. 42, No. 9, June 28, 2024
(1) In the event an application for renewal
			 of any type of license, permit, registration, certification or any similar
			 document issued and required by the Alabama Pharmacy Practice Act, the Alabama
			 Uniform Controlled Substances Act or any applicable Rule and the appropriate
			 renewal fee is not received in the Board's office by December 31 of the
			 applicable year, but is received in the Board's office no later than January 31
			 of the following year and activities requiring renewal were ongoing, a
			 non-disciplinary administrative penalty as indicated below shall be received in
			 the Board Office within fourteen (14) days of the Board's receipt of the
			 renewal and if not, the opportunity to avoid discipline shall no longer be
			 available, rather the Board shall initiate appropriate disciplinary actions.
			 This penalty shall be in addition to the prevailing renewal fee.
(a) Pharmacy permits to include retail,
			 institutional, non-resident pharmacies, and pharmacy services permits -
			 $1,000.00.
(b) Pharmacist license -
			 $1,000.00
(c) Technician
			 Registration - $250.00
(d)
			 Pharmacist controlled substance permits - $500.00
(e) Pharmacy controlled substance permits to
			 include retail, institutional, and non-resident pharmacies - $500.00
(f) Drug manufacturers; Wholesale
			 Distributors; Private Label Distributors, Repackagers, Third-Party Logistics,
			 503B Outsourcers, Retail Oxygen Supplier, Oxygen Manufacturer, and any entities
			 which may be regulated in the future -$1,000.00.
(g) Controlled Substance permits for Drug
			 manufacturers; Wholesale Distributors; Private Label Distributors, Repackagers,
			 Third-Party Logistics, 503B Outsourcers - $500
(h) This Rule is adopted pursuant to the
			 Board's authority set forth in
Code of Ala. 1975
,
			 §
									34-23-33(b) and
			 is in lieu of formal disciplinary proceedings.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.42 - Requirements For The Disposal of Prescription Drug By Pharmacies Collected From Ultimate User(s) Or Person(s) Entitled To Dispose Of Drugs

Current through Register Vol. 42, No. 9, June 28, 2024
(1) This Rule shall
			 apply only to the collection and disposal of prescription drugs by pharmacies
			 returned or received from an ultimate user or a person entitled to dispose of
			 prescription drugs.
(2) An ultimate
			 user is a person who has lawfully obtained and who possesses the controlled
			 substance for his own use or for the use of a member of his/her household or an
			 animal owned by him/her or a member of his/her household.
(3) A person entitled to dispose of
			 prescription drugs is one lawfully entitled to dispose of a decedent's property
			 if that decedent was an ultimate user who died while in possession of
			 prescription drugs (hereinafter referred to as Other Person(s)).
(4) Any pharmacy which intends to receive,
			 collect and dispose of controlled substances from an ultimate user(s) or Other
			 Person(s) shall comply with the applicable provisions of any existing rule or
			 regulation or any amendment or revision thereto adopted pursuant to the Secure
			 and Responsible Drug Disposal Act of 2010. Each such pharmacy shall submit to
			 the Board the necessary authorization to be a collector issued by the DEA
			 within ten (10) days of the receipt thereof. In the event any such pharmacy
			 ceases activities as a collector the Board shall be notified in the same manner
			 as required by the applicable Federal rule or regulation.
(5) Any pharmacy who also intends to receive,
			 collect and dispose of non-controlled prescription drugs from ultimate user(s)
			 or from Other Person(s) shall also comply with the same requirements relating
			 to controlled substances with the exception of any requirement for
			 authorization from the DEA. Each such pharmacy shall notify the Board at the
			 same time of the submission of the Authorization referenced in Paragraph 3
			 above as well as the notification at the same time if such pharmacy ceases
			 activities as a collector referenced in Paragraph 3 above. Author:
Author:
James S. Ward, J.D
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.
Alabama Administrative Code › Title 680 - ALABAMA STATE BOARD OF PHARMACY › Chapter 680-X-2 - PRACTICE OF PHARMACY › Section 680-X-2-.43 - Requirements For Compounding

Current through Register Vol. 42, No. 9, June 28, 2024
All pharmacies that engage in the compounding of drugs or drug
				products shall comply with all applicable and current regulations of United
				States Pharmacopeia-National Formulary (USP)-NF. Section
				34-23-11
				applies.
Author:
Susan Alverson, R.Ph., Executive
				  Secretary
Statutory Authority:
Code of Ala.
				  1975
, §
										34-23-92.