COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 17, 2008

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		Rule 3.01.20 is being amended to allow the identification of the manufacturer or distributor to not appear on the labeling of a packaged product when a suitable internal record is maintained.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103.

3.01.20  Each packaged container, whether for use in a unit dose distribution system or a traditional dispensing system, shall be labeled in accordance with this regulation.  Any packaged unit dose, single dose or unit of issue container for which return for restocking and redispensing, pursuant to 3.00.80, is anticipated, shall be labeled in accordance with this regulation.  Additionally, any packaged container from which subsequent dispensing may occur, shall be labeled in accordance with this regulation.  Such labeling shall include at least the following:

a.	If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of (d), (e), (f), (g), and (h) of this rule may be omitted from the labeling and maintained in such record.  An internal lot number shall be assigned and shall appear in the labeling.  In a prescription drug outlet the record shall be signed by the pharmacist responsible for each lot packaged.  In another outlet the record shall be signed by the person specified in the Board approved protocol.  The record shall be retained for two years from the date of packaging unless otherwise required by law or regulation.

b.	Name and strength of the medication, and, in the case of a single dose package, the total number of individual tablets or capsules per dose;

c.	A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is less;

d.	The identity of the manufacturer or distributor;

e.	The manufacturer's or distributor's lot number;

f.	The manufacturer’s or distributor’s expiration date;;

g.	The date the product was packaged;

h.	The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non-pharmacist permitted to do so pursuant to protocols approved by the Board;