Oklahoma § 59-355.4 - Substituting interchangeable biological products for

§ 59-355.4. Substituting interchangeable biological products for

prescribed biological products.

A. For the purposes of this section:

1. "Biological product" has the same meaning given to that term

in 42 U.S.C., Section 262; and

2. "Interchangeable biological product" means a biological

product that the U.S. Food and Drug Administration (FDA):

a.

has licensed, and determined to meet the standards for

interchangeability pursuant to 42 U.S.C., Section

262(k)(4), or

b.

has determined is therapeutically equivalent as set

forth in the latest edition of or supplement to the

United States Food and Drug Administration's (FDA)

Oklahoma Statutes - Title 59. Professions and Occupations

Approved Drug Products with Therapeutic Equivalence

Evaluations.

B. A pharmacist may substitute an interchangeable biological

product for a prescribed biological product if:

1. The substituted product has been determined by FDA to be

interchangeable, as defined in subsection A of this section, with

the prescribed biological product;

2. The prescribing health care provider does not express a

preference against substitution in writing, verbally or

electronically; and

3. The pharmacy informs the patient of the substitution.

C. The dispensing pharmacist or the pharmacist's designee shall

make an entry into an electronic records system of the specific

product provided to the patient including the name of the product

and the manufacturer. The communication shall be conveyed by making

an entry through:

1. An interoperable electronic medical records system;

2. An electronic prescribing technology;

3. A pharmacy benefit management system; or

4. A pharmacy record.

D. Entry into an electronic records system as described in

subsection C of this section is presumed to provide notice to the

prescriber. If no electronic records system is in use by the

pharmacy, the pharmacist shall communicate the biological product

dispensed to the prescriber using facsimile, telephone, electronic

transmission or other prevailing means, except that communication

shall not be required where:

1. There is no FDA-approved interchangeable biological product

for the product prescribed; or

2. A refill prescription is not changed from the product

dispensed on the prior filling of the prescription.

E. The dispensing pharmacist or a prescriber shall not be:

1. Required to show proof that the prescriber has access to the

record in any type of payment audit conducted by a payer or pharmacy

benefit manager; or

2. Subject to disciplinary action or civil penalties for

failure to ensure that the record is accessible or for failure to

access the record.

F. The State Board of Pharmacy shall maintain a link on its

Internet website to the current list of all biological products

determined by the FDA to be interchangeable with a specific

biological product.

G. Nothing in this section shall preclude existing approved

brand and generic substitutions.

Added by Laws 2021, c. 167, § 1, eff. Nov. 1, 2021.