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Developed and maintained by the Division of Legislative Automated Systems.
1995 SESSION
LD6093364Be it enacted by the General Assembly of Virginia:
1. That § 32.1-81 of the Code of Virginia is amended and reenacted as follows:
§ 32.1-81. Amendments to the Formulary.
A. The Formulary Board shall recommend to the State Board of Health a
Formulary and any subsequent revisions or amendments to the Formulary. The
State Board of Health may accept or reject some or all of the recommendations
of the Formulary Board but may not otherwise revise, amend or add to such
recommendations, upon application, review, a determination of
acceptability by the Formulary Board, and approval by the Commissioner,
include drug products in the Formulary if such drugs have been approved by
the federal Food and Drug Administration (FDA) with an A (therapeutically
equivalent) category rating.
B. In formulating its recommendations regarding revisions or amendments
to the Formulary to the State Board of Health, the The
Formulary Board shall not be deemed to be formulating regulations for
the purposes of the Administrative Process Act (§ 9-6.14:1 et seq.) when
adding or deleting drug products from the Formulary. The Formulary
Board shall, however, conduct public hearings prior to making such
recommendations to the Board of Health listing any drug products
which are not approved by the FDA with an A (therapeutically equivalent)
category ratings or any proposed, nonemergency deletions from the
Formulary. The Formulary Board shall give thirty days' written notice
by mail of the time and place of its hearings to any manufacturer or other
supplier who would be aggrieved by the Formulary Board's proposed
recommendations and to those manufacturers and other suppliers who request
the Formulary Board in writing that they be informed of such hearings. In
addition, the Formulary Board shall give thirty days' notice of such public
hearings to the public by publishing its intention to conduct hearings in the
Calendar of Events of the Virginia Register of Regulations and a newspaper of
general circulation located in Richmond. Following the public hearing
and, upon approval of the Commissioner, the Formulary Board may amend the
Formulary.
B. Upon notification from the Federal Drug Administration that a
drug product's therapeutic equivalence evaluation has been changed from an A
(therapeutically equivalent) category rating to any B category rating
indicating therapeutic inequivalence or questionable equivalence, the
Formulary Board may recommend to the State Board of Health or the
Commissioner, pursuant to § 32.1-20, that the Formulary be summarily
amended to delete the drug product simultaneously with the institution of
proceedings for a public hearing. In acting on the Formulary Board's
recommendations, the State Board of Health Commissioner
need not conduct further proceedings under the Administrative Process
Act.