22-5D-2
Section 22-5D-2 Definitions. As used in this act, the following words have the following meanings:
(1) ELIGIBLE PATIENT. An individual who meets all of the following conditions: a. Has a terminal
illness, attested to by the patient's treating physician. b. Has considered all other treatment
options currently approved by the U. S. Food and Drug Administration. c. Has received a recommendation
from his or her physician for an investigational drug, biological product, or device. d. Has
given written, informed consent for the use of the investigational drug, biological product,
or device. e. Has documentation from his or her physician that he or she meets the requirements
of this subdivision. (2) INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, or DEVICE. A drug, biological
product, or device that has successfully completed phase 1 of a clinical trial but has not
yet been approved for general use by the U. S. Food and Drug Administration and remains under
investigation in a U. S. Food and Drug...
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34-23-1
Section 34-23-1 Definitions. For the purpose of this chapter, the following words and phrases
shall have the following meanings: (1) ASSOCIATION. The Alabama Pharmacy Association. (2)
BIOLOGICAL PRODUCT. Has the same meaning as the term as defined in 42 U.S.C. §262. (3) BOARD
or STATE BOARD. The Alabama State Board of Pharmacy. (4) CHEMICAL. Any substance of a medicinal
nature, whether simple or compound, obtained through the process of the science and art of
chemistry, whether of organic or inorganic origin. (5) DISPENSE. To sell, distribute, administer,
leave with, give away, dispose of, deliver, or supply a drug or medicine to the ultimate user
or his or her agent. (6) DRUGS. All medicinal substances, preparations, and devices recognized
by the United States Pharmacopoeia and National Formulary, or any revision thereof, and all
substances and preparations intended for external and internal use in the cure, diagnosis,
mitigation, treatment, or prevention of disease in man or animal...
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22-5D-4
Section 22-5D-4 Coverage and costs. (a) This chapter does not expand the coverage required
of an insurer. (b) A health plan, third party administrator, or governmental agency is not
required to provide coverage for the cost of an investigational drug, biological product,
or device, or the cost of services related to the use of an investigational drug, biological
product, or device under this chapter. (c) This chapter does not require any governmental
agency to pay costs associated with the use, care, or treatment of a patient with an investigational
drug, biological product, or device. (d) This chapter does not require a hospital or other
health care facility to provide new or additional services, unless approved by the hospital
or facility. (Act 2015-320, §4.)...
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34-23-8.1
Section 34-23-8.1 Substitution of certain biological products; notice. (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...

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20-2-54
Section 20-2-54 Registration of persons manufacturing, distributing or dispensing controlled
substances - Revocation or suspension of registration - Grounds and procedure generally. (a)
A registration under Section 20-2-52 to manufacture, distribute or dispense a controlled substance
may be suspended or revoked by the certifying boards upon a finding that the registrant: (1)
Has furnished false or fraudulent material information in any application filed under this
article; (2) Has been convicted of a crime under any state or federal law relating to any
controlled substance; (3) Has had his federal registration suspended or revoked to manufacture,
distribute or dispense controlled substances; (4) Has violated the provisions of Chapter 23
of Title 34; or (5) Has, in the opinion of the certifying board, excessively dispensed controlled
substances for any of his patients. a. A registrant may be considered to have excessively
dispensed controlled substances if his certifying board finds...
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34-29-61
Section 34-29-61 Definitions. For the purposes of this article, the following terms shall have
the following meanings ascribed by this section: (1) ACCREDITED SCHOOL OF VETERINARY MEDICINE.
Any veterinary college or division of a university or college that offers the degree of doctor
of veterinary medicine or its equivalent and is accredited by the American Veterinary Medical
Association (AVMA). (2) ANIMAL. Any animal or mammal other than man, including birds, fish,
reptiles, wild or domestic, living or dead. (3) APPLICANT. A person who files an application
to be licensed to practice veterinary medicine or licensed as a veterinary technician. (4)
BOARD. Alabama State Board of Veterinary Medical Examiners. (5) CONSULTING VETERINARIAN. A
veterinarian licensed in another state who gives advice or demonstrates techniques to a licensed
Alabama veterinarian or group of licensed Alabama veterinarians. A consulting veterinarian
shall not utilize this privilege to circumvent the law. (6) DIRECT...
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22-5D-3
Section 22-5D-3 Availability to eligible patient of investigational drug, biological product,
or device. (a) The manufacturer of an investigational drug, biological product, or device
may make available and an eligible patient may request the manufacturer's investigational
drug, biological product, or device under this chapter. This chapter does not require that
a manufacturer make available an investigational drug, biological product, or device to an
eligible patient. (b) A manufacturer may do all of the following: (1) Provide an investigational
drug, biological product, or device to an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture
of the investigational drug, biological product, or device. (Act 2015-320, §3.)...
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22-5D-5
Section 22-5D-5 Liability of heirs. If a patient dies while being treated by an investigational
drug, biological product, or device, the patient's heirs are not liable for any outstanding
debt related to the treatment or lack of insurance due to the treatment. (Act 2015-320, §5.)...

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22-5D-10
Section 22-5D-10 Private cause of action not created under chapter. This chapter does not create
a private cause of action against a manufacturer of an investigational drug, biological product,
or device or against any licensed health care provider, other person, or entity involved in
the care of an eligible patient using the investigational drug, biological product, or device
for any harm done to the eligible patient resulting from the investigational drug, biological
product, or device, if the manufacturer or other person or entity is complying in good faith
with the terms of this chapter, unless there was a failure to exercise reasonable care. (Act
2015-320, §10.)...
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22-5D-9
Section 22-5D-9 Blocking access prohibited; counseling, etc., permitted. An official, employee,
or agent of this state shall not block or attempt to block an eligible patient's access to
an investigational drug, biological product, or device. Counseling, advice, or a recommendation
consistent with medical standards of care from a licensed health care provider is not a violation
of this section. (Act 2015-320, §9.)...
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