SubPart 60-2 - Drug Substitution

Effective Date: 
Thursday, May 11, 1978
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Statutory Authority: 
Public Health Law, Section 206

Section 60-2.1 - Establishment and publication of a list of safe, effective and therapeutically equivalent prescription drugs

Section 60-2.1 Establishment and publication of a list of safe, effective and therapeutically equivalent prescription drugs. (a) A list of safe, effective and therapeutically equivalent prescription drugs which may be substituted for the drug product prescribed, is hereby established and published as Safe, Effective and Therapeutically Equivalent Prescription Drugs as updated and revised pursuant to section 206 of Public Health Law.

(b) The list contains drug products, identified by manufacturers, each of which has been certified or approved by the commissioner of the Federal Food and Drug Administration as being safe and effective for its labeled indications for use and bioequivalent where bioequivalence is a real or potential issue, and are considered therapeutically equivalent provided they are:

(1) marketed under approved new drug applications or abbreviated new drug applications;and

(2) are shown to be bioequivalent in those instances where positive evidence of bioequivalency is necessary.

(c) Unless otherwise specifically noted on such drug list, therapeutic equivalence applies only to pharmaceutically equivalent drug products involving the same:

(1) active ingredient or ingredients;

(2) dosage form; and

(3) strength.

(d) Different brands of the following dosage forms are not considered pharmaceutically equivalent:

(1) enteric coated tablets;

(2) controlled release products;

(3) injectable suspensions, other than antibiotics;

(4) suppositories containing active ingredients for which systemic absorption is necessary for the therapeutic activity; and

(5) different delivery systems for aerosol and nebulizer drugs.

(e) The drug list established by this Subpart shall not apply to drug orders and prescription services of the institutional pharmacy of a hospital as defined in article 28 of the Public Health Law.
 

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Section 60-2.2 - Omissions from the list of safe, effective and therapeutically equivalent prescription drugs

60-2.2 Omissions from the list of safe, effective and therapeutically equivalent prescription drugs. The omission of a drug product from the list of drug products in no way automatically implies that such product is known to be therapeutically nonequivalent to other similar products nor that it is ineffective. Such omission shall indicate that an appropriate bioequivalence standard for all pharmaceutical equivalents of such drug has not yet been established, or that appropriate evidence that the standard has been met by such product has not been submitted to the Food and Drug Administration.
 

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Section 60-2.3 - Identification of manufacturer

60-2.3 Identification of manufacturer. The label affixed to the immediate container in which the drug is sold or dispensed shall indicate the name and strength of the drug product and its manufacturer, unless the prescriber specifically states otherwise.

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