ORS 689.522 Substitution of biological products for prescribed biological products; rules

A pharmacy or pharmacist filling a prescription order for a biological product may not substitute a biological product for the prescribed biological product unless:

The substitute biological product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

The prescribing practitioner has not designated on the prescription that substitution is prohibited;

The patient for whom the biological product is prescribed is informed of the substitution in a manner reasonable under the circumstances; and

The pharmacy or pharmacist retains a record of the substitution for a period of not less than three years.

The State Board of Pharmacy shall, on a website maintained by the board, maintain a link to the current list, if available, of biological products determined by the United States Food and Drug Administration to be interchangeable.

For purposes of this section, the board shall adopt by rule definitions for the terms “biological product” and “interchangeable.”

The rule defining the term “biological product” must be consistent with 42 U.S.C. 262(i)(1).

The rule defining the term “interchangeable” must:

For biological products licensed under the Public Health Service Act, define the biological products that may be substituted for other biological products as having been determined by the United States Food and Drug Administration as meeting the standards in 42 U.S.C. 262(k)(4); and

For biological products approved by the United States Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., define the biological products that may be substituted for other biological products as having been determined by the United States Food and Drug Administration as therapeutically equivalent as set forth in the latest edition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.