This text of Alabama § 34-23-8.1 (Substitution of Certain Biological Products; Notice) is published on Counsel Stack Legal Research, covering Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
(a)No person shall dispense or cause to be dispensed a different biological or brand of biological product in lieu of that ordered or prescribed without the express permission in each case of the person ordering or prescribing the drug, except as provided in this section.
(b)A licensed pharmacist in this state shall be permitted to select for the brand name biological product prescribed by a licensed physician or other practitioner who is located in this state and authorized by law to write prescriptions, hereinafter referred to as “practitioner,” a less expensive interchangeable biological product in all cases where the practitioner expressly authorizes the selection in accordance with subsection (d).
(c)A licensed pharmacist located in this state may select for the brand name biologic
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(a) No person shall dispense or cause to be dispensed a different biological or brand of biological product in lieu of that ordered or prescribed without the express permission in each case of the person ordering or prescribing the drug, except as provided in this section.
(b) A licensed pharmacist in this state shall be permitted to select for the brand name biological product prescribed by a licensed physician or other practitioner who is located in this state and authorized by law to write prescriptions, hereinafter referred to as “practitioner,” a less expensive interchangeable biological product in all cases where the practitioner expressly authorizes the selection in accordance with subsection (d).
(c) A licensed pharmacist located in this state may select for the brand name biological product prescribed by a practitioner who is located in another state or licensing jurisdiction and who is authorized by the laws of that state or jurisdiction to write prescriptions, a less expensive interchangeable biological product, in all cases where the out-of-state licensed physician or other practitioner does not expressly prohibit a substitution.
(d)(1) Every written prescription for a biological product issued in this state by a licensed practitioner shall contain two signature lines. One line shall indicate if the brand is meant to be dispensed, and the other shall indicate if a product selection is permitted. The practitioner shall communicate instructions to the pharmacist by signing on the appropriate line.
(2) An oral or electronic prescription, including an e-fax, from the practitioner for a biological product shall instruct the pharmacist whether or not a less expensive interchangeable biological product may be dispensed. The pharmacist shall note instructions on the file copy of the prescription and retain the prescription form for the period specified by law.
(e) The State Board of Pharmacy may not adopt any rule affecting the subject matter of this section.
(f) When a pharmacist dispenses an interchangeable biological product for the prescribed biological product, the pharmacist, or his or her designee, shall inform the patient or patient’s designee prior to dispensing the interchangeable biological product.
(g)(1) Within 24 hours, not counting the hours of Sunday or recognized federal holidays, a pharmacist, or the designee of the pharmacist, who dispenses a different biological product than that ordered or prescribed shall inform the prescribing physician that a different biological product was substituted for the biological product prescribed and provide the name and manufacturer of the biological product dispensed. The notice to the prescribing physician or other practitioner shall be by any of the following:
a. Electronic message sent to the electronic prescribing system used by the prescribing physician or other practitioner to transmit the prescription to the pharmacy.
b. Telephone.
c. Facsimile.
(2) In any instance where the prescribing practitioner indicates for a pharmacist to communicate using a specific notification method listed in subdivision (1), the pharmacist shall utilize that method of communication. A voicemail left for the prescribing physician or other practitioner at the telephone number provided to the pharmacist or his or her designee shall constitute notice under this section.
(h) A pharmacist, or his or her designee, shall record on the prescription form the name and manufacturer or distributor of any drug product, or the name and manufacturer of any biological product, dispensed as authorized in this section.
(i) Notice to the prescribing physician is not required if a refill prescription is not changed from the product dispensed on the immediately prior filling of the prescription.
(j) Unless otherwise indicated by the practitioner, the prescription label on the dispensing container shall indicate the actual biological product dispensed, either the brand name, or if none, the name of the biosimilar biologic product as referred to by the federal Food and Drug Administration’s Lists of Licensed Biological Products With Reference Product Exclusivity and Biosimilarity of Interchangeability Evaluations (Purple Book), and the name of the manufacturer or a reasonable abbreviation of the name of the manufacturer.
(k) The board may maintain a link on its website to the current list of all biological products that the federal Food and Drug Administration has licensed and meets the standards for “interchangeability” pursuant to 42 U.S.C. §262(k).
(l) Notwithstanding any other provision of this section, a pharmacist may not substitute an interchangeable biologic medication for a biologic medication prescribed to a Medicaid recipient if the Medicaid Agency has determined the prescribed biologic is lower in net cost to the Medicaid Agency after rebates.
(m) This section is intended and shall be construed to apply only to biological drug products.