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17-92-101. Definitions.
Arkansas Code — all titles (historical 2020) · legal_authorities
17-92-101. Definitions.
As used in this chapter:
(1) “Biological product” means a biological product as defined by 42 U.S.C. § 262(i)(1), as it existed on January 1, 2019;
(2) “Credentialing” means the issuance of or approval by the Arkansas State Board of Pharmacy of a credential issued to a pharmacist by an agency approved by the Arkansas State Board of Pharmacy certifying that the pharmacist has met the standards of competency established by the Arkansas State Board of Pharmacy for disease state management or other pharmacy services necessitating a credential;
(3) “Dentist” means a practitioner of dentistry duly licensed under the laws of this or some other state;
(4)(A) “Disease state management” means a strategy that utilizes a team-oriented, multidisciplinary approach to improve healthcare outcomes and quality of care, and when possible, to control healthcare cost through management of targeted chronic disease states.
(B) Disease state management focuses on improving health care from prevention to diagnosis and treatment to ongoing follow-up.
(C) Disease state management will involve, but not be limited to, patient education, self-care techniques, and outpatient drug therapy management pursuant to a patient care plan;
(5) “Drug” shall include all medicines and preparations recognized in the United States Pharmacopeia or the National Formulary as substances intended to be used for the care, mitigation, or prevention of disease of either man or other animals;
(6) “Generically equivalent” means a drug that is pharmaceutically and therapeutically equivalent to the drug prescribed;
(7) “Interchangeable biological product” means a biological product that is interchangeable as defined by 42 U.S.C. § 262(i)(3), as it existed on January 1, 2019;
(8)(A)
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-92-101
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. A text match is a research starting point; applicability is not established.
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Stable record: arkansas_code:legal_authorities:17-92-101
Source file: gov.ar.code.title.17.odt
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Passage SHA-256: 6e92d9df40d2719b9705712104d318bfee87dbcdf5b37385c12eb89841a748df
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17-92-101. Definitions.
As used in this chapter:
(1) “Biological product” means a biological product as defined by 42 U.S.C. § 262(i)(1), as it existed on January 1, 2019;
(2) “Credentialing” means the issuance of or approval by the Arkansas State Board of Pharmacy of a credential issued to a pharmacist by an agency approved by the Arkansas State Board of Pharmacy certifying that the pharmacist has met the standards of competency established by the Arkansas State Board of Pharmacy for disease state management or other pharmacy services necessitating a credential;
(3) “Dentist” means a practitioner of dentistry duly licensed under the laws of this or some other state;
(4)(A) “Disease state management” means a strategy that utilizes a team-oriented, multidisciplinary approach to improve healthcare outcomes and quality of care, and when possible, to control healthcare cost through management of targeted chronic disease states.
(B) Disease state management focuses on improving health care from prevention to diagnosis and treatment to ongoing follow-up.
(C) Disease state management will involve, but not be limited to, patient education, self-care techniques, and outpatient drug therapy management pursuant to a patient care plan;
(5) “Drug” shall include all medicines and preparations recognized in the United States Pharmacopeia or the National Formulary as substances intended to be used for the care, mitigation, or prevention of disease of either man or other animals;
(6) “Generically equivalent” means a drug that is pharmaceutically and therapeutically equivalent to the drug prescribed;
(7) “Interchangeable biological product” means a biological product that is interchangeable as defined by 42 U.S.C. § 262(i)(3), as it existed on January 1, 2019;
(8)(A) “Licensed pharmacist” means a person holding a license under the provisions of this chapter.
(B) A “licensed pharmacist” shall be considered an individual healthcare provider;
(9) “Medicine” means a drug or preparation of drugs in suitable form for use as a curative or remedial substance;
(10) “Optometrist” means a practitioner of optometry duly licensed under the laws of this state;
(11) “Patient care plan” means a written course of action that is patient- or physician- or pharmacist-specific and disease-specific for helping a patient to achieve outcomes that improve a patient's quality of life;
(12) “Pharmaceutically equivalent” means drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical, compendious, or other applicable standards of strength, quality, and purity according to the United States Pharmacopeia or another nationally recognized compendium;
(13) “Pharmacy” means the place licensed by the Arkansas State Board of Pharmacy in which drugs, chemicals, medicines, prescriptions, and poisons are compounded, dispensed, or sold at retail;
(14) “Pharmacy care” means the process by which a pharmacist in consultation with the prescribing practitioner identifies, resolves, and prevents potential and actual drug-related problems and optimizes patient therapy outcomes through the responsible provision of drug therapy or disease state management for the purpose of achieving any of the following definite outcomes that improve a patient's quality of life:
(A) Cure of disease;
(B) Elimination or reduction of a patient's symptomology;
(C) Arresting or slowing a disease process; or
(D) Preventing a disease or symptomology;
(15) “Physician” means a practitioner of medicine duly licensed under the laws of this or some other state;
(16) “Poisons” means any drug, chemical, medicine, or preparation liable to be destructive to adult human life in quantities of sixty (60) grains or less;
(17)(A) “Practice of pharmacy” means the healthcare provider profession of:
(i)(a) Dispensing, selling, distributing, transferring possession of, vending, bartering, or, in accordance with rules adopted by the Arkansas State Board of Pharmacy, administering drugs, medicines, poisons, or chemicals that under the laws of the United States or the State of Arkansas may be sold or dispensed only on the prescription and order of a practitioner authorized by law to prescribe drugs, medicines, poisons, or chemicals.
(b) Except as limited by rules adopted by the Arkansas State Board of Pharmacy, a pharmacist has the ability to administer medications.
(c) Influenza vaccines and influenza immunizations may be administered to a person seven (7) years of age or older under a general written protocol.
(d) Vaccines and immunizations other than influenza vaccines and influenza immunizations may be administered to a person from seven (7) years of age to eighteen (18) years of age under a general written protocol and subject to reporting required under § 20-15-1203 if written consent of the parent or legal guardian of the minor is obtained before the administration of the vaccine or immunization.
(e) Vaccines and immunizations other than influenza vaccines and influenza immunizations may be administered to a person eighteen (18) years of age or older under a general written protocol.
(f) Medications other than vaccines and immunizations may be administered to a person seven (7) years of age or older under a patient-specific order or prescription and subject to reporting of the administration to the prescribing physician.
(g) A general written protocol under subdivisions (17)(A)(i)(c) and (e) of this section and patient-specific orders or prescriptions under subdivisions (17)(A)(i)(d) and (f) of this section shall be from a physician licensed by the Arkansas State Medical Board and practicing in Arkansas or within fifty (50) miles of the Arkansas border.
(h) Under a statewide protocol, a pharmacist may initiate therapy and administer or dispense, or both, drugs that include Naloxone and nicotine replacement therapy products;
(ii) Placing, packing, pouring, or putting into a container for dispensing, sale, distribution, transfer of, possession of, vending, or bartering any drug, medicine, poison, or chemical that under the laws of the United States or the State of Arkansas may be sold or dispensed only on the prescription of a practitioner authorized by law to prescribe drugs, medicines, poisons, or chemicals;
(iii) Placing in or affixing upon any container described in subdivision (17)(A)(ii) of this section a label required to be placed upon drugs, medicines, poisons, or chemicals sold or dispensed upon prescription of a practitioner authorized by law to prescribe those drugs, medicines, poisons, or chemicals;
(iv) Preparing, typing, or writing labels to be placed in or affixed on any container described in subdivision (17)(A)(ii) of this section, which label is required to be placed upon drugs, medicines, poisons, or chemicals sold or dispensed upon prescription of a practitioner authorized by law to prescribe those drugs, medicines, poisons, or chemicals;
(v) Interpreting prescriptions for drugs, medicines, poisons, or chemicals issued by practitioners authorized by law to prescribe drugs, medicines, poisons, or chemicals that may be sold or dispensed only on prescription;
(vi) Selecting, taking from, and replacing upon shelves in the prescription department of a pharmacy or apothecary drugs, medicines, chemicals, or poisons that are required by the laws of the United States or the State of Arkansas to be sold or dispensed only on prescription of a practitioner authorized by law to prescribe them;
(vii) Compounding, mixing, preparing, or combining drugs, medicines, chemicals, or poisons that under the laws of the United States or the State of Arkansas may be sold or dispensed only on the prescription of a practitioner authorized by law to prescribe them;
(viii) Advising and providing information concerning utilization of drugs and devices and participation in drug utilization reviews;
(ix)(a) Performing a specific act of drug therapy management or disease state management delegated to a pharmacist for an individual patient based upon a written protocol or a patient care plan approved by a physician, who shall be licensed in this state under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.
(b) Drug therapy management shall not include the selection of drug products not prescribed by the physician unless the drug products are either named in the physician-initiated protocol or the physician-approved patient care plan;
(x) Providing pharmacy care; and
(xi) Providing pharmacokinetic services.
(B) The provisions of subdivisions (17)(A) and (17)(C) of this section shall not apply to employees of wholesale drug companies or other drug distributors who do not fill prescriptions or sell or dispense drugs to the consumer.
(C)(i) The Arkansas State Board of Pharmacy may permit pharmacy technicians other than pharmacists or interns to perform some or all of those functions described in Arkansas State Board of Pharmacy rules under the direct, personal supervision of a licensed pharmacist pursuant to rules defining the minimum qualifications of such employees, the ratio of pharmacy technicians to supervising pharmacists, and the scope of the duties, practices, and procedures that the Arkansas State Board of Pharmacy determines will promote the delivery of competent, professional pharmaceutical services and promote the public health and welfare. Nothing in this chapter shall be construed as allowing pharmacy technicians to administer medications.
(ii) The conduct of a pharmacy technician is the responsibility of the pharmacist-in-charge and supervising pharmacist of the pharmacy who shall not permit the employee to perform any act, task, or function that involves the exercise of independent judgment by the employee.
(iii) Pharmacy products prepared by pharmacy technicians shall be verified for accuracy by the supervising pharmacist before release for patient use, and the verification shall be documented.
(iv) The use of pharmacy technicians in a manner not authorized by this chapter or rules promulgated hereunder shall be unprofessional conduct by the pharmacist-in-charge and the supervising pharmacist.
(v) It is recognized that hospital pharmacy technicians as defined in § 17-92-602(4) are governed by the Hospital Pharmacies Act, § 17-92-601 et seq., and related Arkansas State Board of Pharmacy rules developed pursuant to that subchapter;
(18)(A) “Prescription” means an order for medicine or medicines usually written as a formula by a physician, optometrist, dentist, veterinarian, or other licensed medicinal practitioner. It contains the names and quantities of the desired substance, with instructions to the pharmacist for its preparation and to the patient for the use of the medicine at a particular time and may authorize the pharmacist to substitute a therapeutically equivalent drug that is at a lower cost to the patient and communicate that authorization by any generally accepted means of communication of a prescription from a prescriber to a pharmacist.
(B) A substitution of a therapeutically equivalent drug shall occur only after the prescriber grants such authorization for each prescription.
(C)(i) Before dispensing, the pharmacist shall discuss verbally any suggested substitution with the patient and inform the patient that the patient has a right to refuse the substitution.
(ii) The discussion under subdivision (18)(C)(i) of this section shall include without limitation:
(a) Notification to the patient that the therapeutically equivalent drug does not contain the identical active ingredient present in the prescribed drug; and
(b) All differences in dosage and frequency between the prescribed drug and the therapeutically equivalent drug.
(D) The pharmacist shall send notice of the substitution to the prescriber in writing or by electronic communication within twenty-four (24) hours after the drug is dispensed to the patient.
(E) Subdivision (18)(B) of this section does not apply to specific acts of drug therapy management or disease state management delegated to a pharmacist based upon a written protocol or patient care plan approved by a physician under subdivision (17)(A)(ix) of this section;
(19) “Proprietary medicines”, when not otherwise limited, means remedies that a certain individual or individuals have the exclusive right to manufacture or sell;
(20) “Statewide protocol” means a standardized procedure or protocol approved by the Arkansas State Board of Pharmacy and the Arkansas State Medical Board authorizing a pharmacist to initiate therapy and administer or dispense, or both, a drug or device;
(21) “Supervision” means under the direct charge or direction of and does not contemplate any continued absence of such supervision;
(22) “Therapeutic class” means a group of similar drug products that have the same or similar mechanisms of action and are used to treat a specific condition;
(23) “Therapeutically equivalent” means drug products from the same therapeutic class that if administered in appropriate amounts will provide the same therapeutic effect, identical in duration and intensity;
(24) “Veterinarian” means a practitioner of veterinary medicine duly licensed under the laws of this or some other state; and
(25) “Written protocol” means a physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Arkansas State Medical Board under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 456
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 258a
§ 258a. Transferred
Editorial Notes
CODIFICATION
Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat.
269, which related to transfer of balances in working
capital fund, narcotic hospitals, to surplus fund, was
transferred and is set out as a note under section 290aa
of this title.
§§ 259 to 261a. Repealed. Pub. L. 106–310, div. B,
title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat.
1221, as amended by Pub. L. 114–198, title I,
§ 110(b), July 22, 2016, 130 Stat. 710
Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58
Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct.
27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86
Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98
Stat. 2031, related to convict addicts or other persons
with drug abuse or drug dependence problems.
Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58
Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24,
1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513,
title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re-
lated to addicts and persons with drug abuse or drug
dependence problems.
Section 260a, act July 1, 1944, ch. 373, title III, § 345, as
added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July
24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L.
91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re-
lated to admission of addicts committed from District
of Columbia.
Section 261, acts July 1, 1944, ch. 373, title III, § 346,
formerly § 345, 58 Stat. 701; renumbered § 346, May 8,
1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513,
title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.
Arkansas Code — all titles (historical 2020) · legal_authorities
17-95-201. Short title.
Sections 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq., shall be known as the “Arkansas Medical Practices Act”.
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-95-201
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 17-95-201. This identifies an authority to review, not proof of applicability.
Arkansas Code — all titles (historical 2020) · legal_authorities
17-95-301. Creation — Members.
(a) There is created the Arkansas State Medical Board.
(b)(1)(A) The board shall consist of fourteen (14) members appointed by the Governor for terms of six (6) years.
(B) The Governor shall consider diversity of practice specialties and geographical areas of practice in making appointments to the board.
(2)(A)(i) Ten (10) members shall be duly qualified, licensed, and active medical practitioners and appointed by the Governor after consulting the Arkansas Medical Society, Inc., and subject to confirmation by the Senate.
(ii) At least two (2) members shall be appointed from each of the state's four (4) congressional districts.
(iii) Two (2) members shall be appointed at large.
(B) Congressional district representation required under this subdivision (b)(2) shall be achieved by appointment as vacancies occur.
(3) One (1) member shall be a licensed practicing physician in this state and shall be appointed by the Governor after consulting the Physicians' Section of the Arkansas Medical, Dental, and Pharmaceutical Association, Inc. and subject to confirmation by the Senate.
(4) Two (2) members of the board shall not be actively engaged in or retired from the practice of medicine. One (1) member shall represent consumers, and one (1) member shall be sixty (60) years of age or older and shall represent the elderly. Both shall be appointed from the state at large subject to confirmation by the Senate. The two (2) positions may not be held by the same person. Both shall be full voting members but shall not participate in the grading of examinations.
(5) One (1) member shall be a duly qualified, licensed, and practicing osteopathic physician and appointed after consulting the Arkansas Osteopathic Medical Association and subject
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-95-301
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 17-95-301. This identifies an authority to review, not proof of applicability.
Arkansas Code — all titles (historical 2020) · legal_authorities
17-95-401. License required.
If any person who does not possess a valid license to practice medicine within this state and who is not exempted from the licensing requirements does any of the acts constituting the practice of medicine, he or she shall be deemed to be practicing medicine without complying with the provisions of the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-95-401
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 17-95-401. This identifies an authority to review, not proof of applicability.
Arkansas Code — all titles (historical 2020) · legal_authorities
20-15-1203. Duty of providers — Penalty.
(a)(1) A provider shall register with the Department of Health the intent to administer childhood immunizations to an individual under twenty-two (22) years of age under guidelines established by the department.
(2) A provider shall report to the department the administration of a childhood immunization to an individual under twenty-two (22) years of age.
(3) A provider may report the administration of adult immunizations to individuals twenty-two (22) years of age or older to the department.
(b) A provider who administers a childhood immunization and fails to register with the department or make the required reports to the department, or both, shall be fined twenty-five dollars ($25.00).
Source: Arkansas Code — historical release 78 (November 6, 2020) · 20-15-1203
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 20-15-1203. This identifies an authority to review, not proof of applicability.