Or. Admin. Code § 855-060-0027

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-060-0027 - Identification of Prescription Drugs

(1) All prescription drug products in tablet or capsule form intended for oral administration will be required to be specifically identified. These drug products, when sold or distributed in Oregon, must be marked by the manufacturer with a code imprint identifying the drug product and the manufacturer or distributor of the drug product.

(2) "Code imprint" means an individual symbol, number, company name, words, letters, marking, National Drug Code, or any combination thereof, identifying the drug product and the manufacturer or distributor of the drug product.

(3) Exceptions to the requirement are:

(a) Drug products which are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and which are to be used solely by the patient for whom prescribed;

(b) Drug products which are used for experimentation or research purposes.

(4) The Board of Pharmacy, upon application of a manufacturer or distributor, may also exempt a particular drug product from the requirements of this regulation on the grounds that imprinting is not feasible because of such drug product's size, texture, or other unique characteristics.

Or. Admin. Code § 855-060-0027

1PB 2-1981, f. & ef. 8-20-81; BP 4-2015, f. & cert. ef. 7/1/2015

Stat. Auth.: ORS 475 & 689.205

Stats. Implemented: ORS 689.155