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-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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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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22-5D-7
Section 22-5D-7 Relation to other laws and professional obligations. (a) Nothing in this chapter
shall be construed to establish a standard of care for physicians or otherwise modify, amend,
or supersede any provision of the Alabama Medical Liability Act of 1987 or the Alabama Medical
Liability Act of 1996, commencing with Section 6-5-540 et seq., or any amendment thereto,
or any judicial interpretation thereof. (b) This chapter does not require a medical professional
who is licensed under the laws of this state to counsel, advise, prescribe, dispense, administer,
or otherwise be involved in the care of an eligible patient using an investigational drug,
biological product, or device. (c) This chapter does not require a hospital licensed under
Section 22-21-25 to provide any service related to an investigational drug, biological product,
or device. (Act 2015-320, §7.)...
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22-5D-6
Section 22-5D-6 Effect on license or certification. A licensing board or disciplinary subcommittee
shall not issue a letter of concern or similar form of reprimand, nor revoke, fail to renew,
suspend, or take any action against a health care provider's license issued under Title 34,
based solely on the health care provider's recommendations to an eligible patient regarding
access to or treatment with an investigational drug, biological product, or device. An entity
responsible for Medicare certification shall not reprimand or take action against a health
care provider's Medicare certification based solely on the health care provider's recommendation
that a patient have access to an investigational drug, biological product, or device. (Act
2015-320, §6.)...
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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-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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22-5D-8
Section 22-5D-8 Additional coverage not required under Medicaid. This chapter does not require
the Alabama Medicaid Program to provide additional coverage for an investigational drug, biological
product, or device. (Act 2015-320, §8.)...
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34-23-150
Section 34-23-150 Definitions. As used in this article, the following terms shall have the
following meanings: (1) BOARD. The Alabama State Board of Pharmacy. (2) COMPONENT. Any ingredient
used in the compounding of a drug product. (3) COMPOUNDING. The preparation, mixing, assembling,
packaging, and labeling of a drug or device as the result of a licensed practitioner's prescription
drug order or initiative based on the practitioner/patient/pharmacist relationship in the
course of professional practice. a. Compounding may also be for the purpose of, or as incident
to, research, teaching, or chemical analysis. b. Compounding includes the preparation of drugs
or devices in anticipation of prescription drug orders based on routine, regularly observed
prescribing patterns. c. Reconstitution of commercial products is not considered compounding
for purposes of this article. (4) COMPOUNDED OVER THE COUNTER (OTC) PRODUCTS. A medical product
that is prepared, packaged, and labeled in a pharmacy...
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