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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
Food and Drug Administration has made either a determination of licensure based on standards
for interchangeability pursuant to 42 U.S.C. §262(k)(4), or a determination of therapeutic
equivalence based on the latest edition of or supplement to the federal Food and Drug Administration's
publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
(10) INTERN. An individual who is currently licensed by this state to engage in the practice
of pharmacy while under the personal supervision of a pharmacist and is satisfactorily
progressing toward meeting the requirements for licensure as a pharmacist, a graduate of an
approved college of pharmacy who is currently licensed by the board for the purpose of obtaining
practical experience as a requirement for licensure as a pharmacist, or a qualified applicant
awaiting examination for licensure. (11) LEGEND DRUG. Any drug, medicine, chemical, or poison
bearing on the label the words, "Caution, federal law prohibits...
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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
VETERINARIAN. A person who is validly and currently licensed to practice veterinary medicine
in Alabama. (13) LICENSED VETERINARY TECHNICIAN. A person who is validly and currently licensed
to practice as a veterinary technician in Alabama. (14) PERSON. Any individual, firm, partnership,
association, joint venture, cooperative, or corporation or any other group or combination
acting in concert; and whether or not acting as a principal, trustee, fiduciary, receiver,
or as any kind of legal or personal representative, or as the successor in interest,
assigning agent, factor, servant, employee, director, officer, or any other representative
of such person. (15) PRACTICE OF VETERINARY MEDICINE: a. To diagnose, treat, correct, change,
relieve, or prevent animal disease, deformity, defect, injury, or other physical or
mental condition; including the prescription or administration of any drug, medicine, biologic,
apparatus, application, anesthesia, or other therapeutic or diagnostic...
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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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