Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 790 - ILLINOIS FORMULARY FOR THE DRUG PRODUCT SELECTION PROGRAM › Subpart A - GENERAL PROVISIONS › Section 790.40 - Consideration of Drug Products for Inclusion in the Illinois Formulary

Current through Register Vol. 48, No. 28, July 12, 2024
a) Drug products
				for inclusion in the Illinois Formulary shall be approved and recommended to
				the Director of Public Health by a Technical Advisory Council according to the
				notice and hearing provisions of this Section. The Council is composed of 7
				members, each of whom has extensive experience in pharmaceutical affairs.
				Products for Council consideration shall be researched and presented by
				Department staff following consideration of recommendations by the federal Food
				and Drug Administration (FDA), of recognized drug reference sources, of
				published research, and of qualified consultants.
b) No product shall be considered for
				inclusion in the Illinois Formulary unless each individual dosage form, dosage
				strength and manufacturer has been recommended for drug product selection use
				by the FDA. Each product considered must be verified by the FDA as being
				marketed under currently approved drug applications, as meeting required
				manufacturing standards and chemical identity standards, and as being cleared
				of any issues involving the bioequivalence or bioavailability of the product.
				Prior to being sanctioned for DPS use, the product must pass FDA criteria
				specific for DPS approval which criteria may be more stringent than that
				required for general marketing approval. "Bioequivalence" and "bioavailability"
				have the meanings prescribed under
				21
				CFR 320.1, April 1, 1999.
c) Generic Drug Products.
1) Drug products previously approved by the
				Technical Advisory Council for generic interchange may be substituted in the
				State of Illinois without further review subject to the conditions of approval
				in the State before September 1, 2000 (the effective date of Public Act 91-766)
				(Section 3.14 of the Illinois Food, Drug and Cosmetic Act [410
				ILCS 620/3.14 ]). Drug products requiring approval by
				the Council on or after September 1, 2000, for generic interchange are subject
				to the notice and hearing provisions of this Section.
2) If not subject to a hearing under
				subsection (c)(5) or if not specifically prohibited, then generic drug products
				determined to be therapeutically equivalent by the FDA shall be available for
				substitution in this State no sooner than 60 days after the submission of the
				prescribed notification under subsection (d) to the Council. "Therapeutic
				equivalence" has the meaning prescribed under the current edition or supplement
				of the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations",
				21
				CFR 314.3, April 1, 1999.
3) Manufacturers of the generic drug products
				shall submit to the Council the notification described in subsection (d) at
				least 60 days before the scheduled substitution of the drug product. During the
				60-day notification period, the Council shall determine, based upon a
				preponderance of the evidence, whether the generic drug product has issues
				related to the practice of medicine or the practice of pharmacy.
4) If the Council determines that the generic
				drug product does not have issues related to the practice of medicine or
				pharmacy, then the Council shall issue its recommendation of approval of the
				generic drug product to the Director. If included on the Drug Products
				Selection Formulary by the Director under subsection (f), then the drug product
				may be substituted in the State after either the 60-day notification period,
				the date of the Director's approval, or the date of the product's full approval
				for safety and efficacy by the FDA, whichever date is later.
5) If the Council determines that the generic
				drug product has issues related to the practice of medicine or pharmacy, then:
A) a hearing on the drug product shall be
				held under subsection (e) at the Council's next regularly scheduled
				meeting;
B) the Council's hearing
				determination shall be reviewed by the Director under subsection (f);
				and
C) the drug product may not be
				substituted in the State unless included in the Drug Products Selection
				Formulary by the Director.