West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-33 - Regulations for the Establishment of a Controlled Substances Therapeutic Research Program and the Certification of Patients, Practitioners and Hospital Pharmacies › Section 64-33-6 - Drug Procurement - Physician Eligibility

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. A physician is eligible to prescribe
				delta-9- THC (marihuana) if he meets the following criteria.
6.1.1 The patient qualification review board
				shall review and certify physician practioners for participation in the
				controlled substances therapeutic research program.
6.1.2. Each physician desiring to participate
				in the controlled substances therapeutic research program shall apply to the
				patient qualification review board in a format prescribed by such board.
6.1.3. The physician shall
				document experience in cancer therapy.
6.1.4. The physician shall have a current
				drug enforcement administration controlled substances registration number.
6.1.5. The physician shall
				register with a registered pharmacy as hereinafter described and the National
				Cancer Institute.
6.1.6. The
				physician shall affirm that the patient has signed an informed consent form. A
				copy of such signed consent form shall be maintained by the patient
				qualification review board.
6.1.7.
				The physician shall limit drug usage to the purposes herein contained.
6.1.8. The physician shall report
				adverse drug reactions immediately to the Investigational Drug Bank, National
				Cancer Institute and to the patient qualification review board.
6.1.9. The patient qualification review hoard
				shall issue a certificate of registry to each physician meeting the
				requirements of these rules and regulations. The patient qualification review
				board may revoke such certificate of registry for good cause shown. Those
				affected persons desiring a public hearing shall do so in the manner prescribed
				in and by the Rules of Procedure for Contested Case Hearings and Declaratory
				Rulings, West Virginia Department of Health Procedural Rules, Series I, 1983.
				The aforementioned rules of procedure are incorporated herein by reference.
6.1.10. Physicians wishing to
				participate in the controlled substances therapeutic research program shall
				register by completing and signing Federal Drug Administration Form 1573. Upon
				certification by the patient qualification review board such Federal Drug
				Administration Form 1573 shall be presented to a registered pharmacy which will
				submit the form to the National Cancer Institute for approval.
6.1.11. The National Cancer Institute will
				notify the applicant pharmacy of the physician's eligibility status and the
				physician will be notified by the registered pharmacy.
6.1.12. Once certified, registered and
				approved the prescribing physician shall complete a "Research Order for
				Medication." The Research Order for Medication will be presented to a
				registered pharmacy by the patient. Such Research Order for Medication is
				identical to a prescription order. A standard prescription blank may be used,
				but it must contain a statement that informed patient consent has been
				obtained.
6.1.13. The quantity of
				delta 9-THC dispensed is limited to 25 capsules (5mg strength) for each single
				prescription.
6.1.14. The director
				shall apply to contract with the National Institute on Drug Abuse or any
				federally registered distributor or manufacturer for receipt of marihunana
				pursuant to and in accordance with regulations promulgated by the National
				Institute on Drug Abuse, the Food and Drug Administration and pursuant to the
				provisions of these rules and regulations.
6.1.15. The director may cause such analyzed
				marihuana to be transferred to a certified licensed pharmacy for distribution
				to a certified patient upon the written prescription of a certified practioner
				pursuant to the provisions of these rules and regulations.
6.1.16. The physician shall advise the
				patient as to the effects and possible side effects of the drug (delta 9-THC)
				prior to the initial administration thereof.
6.1.17. The director shall provide each
				registered physician and registered pharmacy with a copy of the Group C
				Guidelines for the use of Delta 9-Tetraydrocannabinol NSC 134454 for Nausea and
				Vomiting Induced by Antineplastic Chemotherapy, September 1980, Investigational
				Drug Branch Cancer Therapy Evaluation Program, Bethesda,. Maryland.
6.1.18. Delta 9-THC (marihuana) shall be
				provided to each qualified patient pursuant to these rules and regulations at
				no cost.