(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.
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