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ACROSS SESSIONS
- Subject Index: Since 1995
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Developed and maintained by the Division of Legislative Automated Systems.
1995 SESSION
Be 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 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 rating 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.
C. 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.