AUTHORITY: Implementing and authorized by Section 3.14 of the Illinois Food, Drug and Cosmetic Act [410 ILCS 620/3.14] and Section 25 of the Pharmacy Practice Act [225 ILCS 85/5].
SOURCE: Emergency amendment at 2 Ill. Reg. 18, p. 47, effective April 26, 1978, for a maximum of 150 days; amended at 2 Ill. Reg. 26, p. 150, effective July 1, 1978; emergency amendment at 2 Ill. Reg. 40, p. 98, effective October 1, 1978, for a maximum of 150 days; amended at 2 Ill. Reg. 51, p. 48, effective December 18, 1978; emergency amendment at 3 Ill. Reg. 2, p. 18, effective December 31, 1978, for a maximum of 150 days; emergency amendment at 3 Ill. Reg. 15, p. 147, effective April 1, 1979, for a maximum of 150 days; amended at 3 Ill. Reg. 27, p. 113, effective July 1, 1979; emergency amendment at 3 Ill. Reg. 32, p. 158, effective August 1, 1979, for a maximum of 150 days; amended at 3 Ill. Reg. 41, p. 178, effective October 8, 1979; emergency amendment at 4 Ill. Reg. 51, p. 147, effective December 12, 1980, for a maximum of 150 days; amended at 5 Ill. Reg. 3466, effective March 25, 1981; amended at 5 Ill. Reg. 7107, effective June 24, 1981; amended at 5 Ill. Reg. 9120, effective October 1, 1981; amended at 5 Ill. Reg. 14605, effective February 1, 1982; amended at 6 Ill. Reg. 6750, effective July 1, 1982; amended at 6 Ill. Reg. 11558, effective September 15, 1982; amended at 6 Ill. Reg. 15195, effective December 15, 1982; amended at 7 Ill. Reg. 7110, effective July 1, 1983; amended at 7 Ill. Reg. 13270, effective October 1, 1983; amended at 7 Ill. Reg. 16924, effective January 1, 1984; amended at 8 Ill. Reg. 2162, effective March 1, 1984; amended at 8 Ill. Reg. 8513, effective July 1, 1984; codified at 8 Ill. Reg. 13402; amended at 8 Ill. Reg. 22108, effective November 1, 1984; amended at 9 Ill. Reg. 4071, effective April 1, 1985; amended at 9 Ill. Reg. 6816, effective May 1, 1985; amended at 10 Ill. Reg. 253, effective January 1, 1986; amended at 10 Ill. Reg. 8814, effective May 15, 1986; amended at 11 Ill. Reg. 3565, effective February 23, 1987; amended at 11 Ill. Reg. 9223, effective May 15, 1987; amended at 11 Ill. Reg. 14382, effective August 15, 1987; amended at 12 Ill. Reg. 1823, effective January 1, 1988; emergency amendment at 12 Ill. Reg. 1984, effective January 1, 1988, for a maximum of 150 days; emergency amendment at 12 Ill. Reg. 7743, effective April 15, 1988, for a maximum of 150 days; amended at 12 Ill. Reg. 9153, effective May 13, 1988; amended at 12 Ill. Reg. 10133, effective May 31, 1988; emergency amendment at 12 Ill. Reg. 10745, effective June 2, 1988, for a maximum of 150 days; amended at 12 Ill. Reg. 12846, effective July 29, 1988; emergency amendment at 12 Ill. Reg. 13255, effective August 5, 1988, for a maximum of 150 days; emergency expired January 2, 1989; amended at 12 Ill. Reg. 15101, effective September 16, 1988; emergency amendment at 12 Ill. Reg. 16937, effective October 7, 1988, for a maximum of 150 days; amended at 13 Ill. Reg. 856, effective January 6, 1989; emergency amendment at 13 Ill. Reg. 3108, effective February 28, 1989, for a maximum of 150 days; amended at 13 Ill. Reg. 8890, effective May 26, 1989, and January 1, 1990; amended at 13 Ill. Reg. 11717, effective July 14, 1989; corrected at 13 Ill. Reg. 12909; emergency amendment at 13 Ill. Reg. 12990, effective August 1, 1989, for a maximum of 150 days; corrected at 13 Ill. Reg. 14477; emergency amendment at 13 Ill. Reg. 17101, effective October 13, 1989, for a maximum of 150 days; amended at 13 Ill. Reg. 19770, effective December 8, 1989; emergency amendment at 14 Ill. Reg. 1505, effective January 12, 1990, for a maximum of 150 days; amended at 14 Ill. Reg. 3184, effective February 16, 1990; emergency amendment at 14 Ill. Reg. 4620, effective March 9, 1990, for a maximum of 150 days; amended at 14 Ill. Reg. 8154, effective May 11, 1990; emergency amendment at 14 Ill. Reg. 9556, effective June 1, 1990, for a maximum of 150 days; amended at 14 Ill. Reg. 11988, effective July 13, 1990; emergency amendment at 14 Ill. Reg. 13325, effective August 10, 1990, for a maximum of 150 days; amended at 14 Ill. Reg. 17298, effective October 5, 1990; emergency amendment at 14 Ill. Reg. 18588, effective November 9, 1990, for a maximum of 150 days; emergency expired April 8, 1991; amended at 14 Ill. Reg. 20755, effective December 21, 1990; emergency amendment at 15 Ill. Reg. 3537, effective March 8, 1991, for a maximum of 150 days; amended at 15 Ill. Reg. 6566, effective April 19, 1991; emergency amendment at 15 Ill. Reg. 11194, effective July 19, 1991, for a maximum of 150 days; amended at 15 Ill. Reg. 11791, effective August 2, 1991; emergency amendment at 15 Ill. Reg. 16484, effective October 25, 1991, for a maximum of 150 days; amended at 15 Ill. Reg. 18697, effective December 13, 1991; emergency amendment at 16 Ill. Reg. 4899, effective March 14, 1992, for a maximum of 150 days; amended at 16 Ill. Reg. 5941, effective March 24, 1992; emergency amendment at 16 Ill. Reg. 8571, effective May 22, 1992, for a maximum of 150 days; amended at 16 Ill. Reg. 12913, effective August 10, 1992; amended at 16 Ill. Reg. 16019, effective September 30, 1992; emergency amendment at 16 Ill. Reg. 17781, effective November 9, 1992, for a maximum of 150 days; emergency amendment at 17 Ill. Reg. 7283, effective May 7, 1993, for a maximum of 150 days; amended at 17 Ill. Reg. 15916, effective September 20, 1993; amended at 24 Ill. Reg. 18711, effective December 8, 2000.
SUBPART A: GENERAL PROVISIONS
Section 790.10 Incorporated Materials
a) The following materials are incorporated by reference in this Part and include no later amendments or editions:
1) Section 314.1, Definitions for the Applications for FDA Approval to Market a New Drug, 21 CFR 314.3, April 1, 1999.
2) Section 320.1, Definitions for the Bioavailability and Bioequivalence Requirements, 21 CFR 320.1, April 1, 1999.
b) Incorporations or references refer to the materials on the date specified and do not include later amendments or editions.
c) Copies of incorporated or referenced materials are available for inspection and copying at the Department of Public Health, Office of Health Protection, Division of Food, Drugs and Dairies, Drug Product Selection Program, 525 West Jefferson Street, 2nd Floor, Springfield, Illinois 62761-0001.
(Source: Added at 24 Ill. Reg. 18711, effective December 8, 2000)
Section 790.20 Introduction
a) The Illinois Food, Drug and Cosmetic Act (Ill. Rev. Stat. 1987, ch. 56 1/2, par. 503.14) [410 ILCS 620/3.14] allows interchange of different brands or nonbrands of the same generic drug entity for a drug product prescribed by a specific trade name. Products selected for interchange must be pharmaceutically equivalent to the prescribed product and must be listed in a positive drug product formulary known as the Illinois Formulary which has been developed, maintained and issued by the Illinois Department of Public Health (hereinafter referred to as the "Department"). The practice of selecting an equivalent drug product from the Illinois Formulary to dispense instead of the trade name product prescribed is known as Drug Product Selection (DPS).
b) The initial issue of the Illinois Formulary for use in Drug Product Selection became effective on July 1, 1978. Periodic updates to the Illinois Formulary will be distributed by the Department of Public Health. Single copies of the Illinois Formulary shall be provided to all licensed pharmacies with Illinois addresses. Upon request, single copies of the Illinois Formulary will be provided, at no charge, to licensed prescribers, pharmacists practicing their profession in Illinois, to pharmacists seeking reciprocation, students enrolled in a pharmacy curriculum at the University of Illinois at Chicago, College of Pharmacy, the Chicago College of Pharmacy, the St. Louis College of Pharmacy, students enrolled out-of-state in a college of pharmacy who seek a pharmacist licensure in the State of Illinois, or students enrolled in a pharmacy technician program.
c) The Department shall make available to other interested parties a subscription to the Illinois Formulary and its revisions at a fee of $50.00 per year. All subscription fees collected by the Department shall be deposited into the Food and Drug Safety Fund.
(Source: Amended at 17 Ill. Reg. 15916, effective September 20, 1993)