32-1975

32-1975. Legend drug products; listing; code
identification; exemption; definitions

A. A legend drug product in finished solid oral dosage form shall not be
manufactured or commercially distributed within this state unless it is clearly or
prominently marked or imprinted with a code imprint identifying the drug product and the
manufacturer or distributor of the drug.

B. All manufacturers or distributors of legend drugs in solid dosage form shall
make available on request to the board a listing of all such legend drugs identifying by
code imprint the manufacturer or distributor and the specific type of drug. The listing
shall at all times be kept current by all manufacturers and distributors subject to this
section.

C. The board shall adopt rules for implementing this section.

D. The board may grant exemptions from the requirements of this section on
application of any drug manufacturer or distributor showing size, physical
characteristics or other unique characteristics which render the application of a code
imprint to a legend drug subject to this section impractical or impossible. Any exemption
granted by the board shall be included by the manufacturer or distributor in the listing
required by subsection B of this section, describing the physical characteristics and
type of drug to which the exemption relates.

E. This section does not apply to drug products compounded by a pharmacist licensed
under section 32-1924 in a pharmacy operating under a permit issued by the board.

F. For the purposes of this section:

1. "Code imprint" means a series of letters or numbers assigned by the manufacturer
or distributor to a specific drug or marks or monograms unique to the manufacturer or
distributor of the drug, or both.

2. "Distributor" means a person who distributes for resale a drug in solid dosage
form under that person's own label even if that person is not the actual manufacturer of
the drug.

3. "Legend drug" means any drug defined by section 503(b) of the federal food, drug
and cosmetic act and under which definition its label is required to bear the statement
"Rx only".

4. "Solid dosage form" means capsules or tablets intended for oral use.