02-392-4 Me. Code R. § 26-1

Current through 2024-51, December 18, 2024

Section 392-4-26-1 - Generic and Therapeutically Equivalent Drugs

1. Basis for Categorization

A generic and therapeutically equivalent drug, as defined in 32 M.R.S.A. §13702(11), is a drug that meets the following criteria:

A. Chemical Equivalents. Drug products that contain the same amounts of the same therapeutically active ingredients in the same dosage forms and that meet present compendial standards.

B. Bioequivalents. Chemical equivalents, which when administered to the same individuals in the same dosage regimen will result in comparable bioavailability.

C. Therapeutic Equivalents. Chemical equivalents, which when administered to the same individuals in the same dosage regimen, will provide essentially the same efficacy and/or toxicity.

2. Basis for Determination

In determining whether a drug is generic and therapeutically equivalent, the pharmacist shall rely upon Approved Drug Products With Therapeutic Equivalence Evaluations (U.S. Department of Health and Human Services) (electronic edition current through December 2003; last revised February 2, 2004) (the "Orange Book"). All "A"-coded drug products in the orange book are deemed to be generic and therapeutically equivalent. Substitutable "A"-coded drug products include, but are not limited to, those designated AA, AB, AN, AO, AP, or AT.

The board hereby incorporates the orange book into this chapter by reference. A copy of the Orange Book may be obtained from-

Superintendent of Documents

Government Printing Office

P.O. Box 371954

Pittsburgh, PA 15250-7954

The electronic version may be accessed on line at-

http://www.fda.gov/cder/ob/default.htm

This URL is subject to change.

3. Available Reference

Each drug outlet shall keep a copy of the Orange Book, or the information contained therein, readily accessible at all times.

4. Exception

Notwithstanding the provisions of this chapter, a pharmacist may dispense a "B"-coded drug product to the extent authorized by the MaineCare program.

02-392 C.M.R. ch. 4, § 26-1