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The Oregon Administrative Rules contain OARs filed through August 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 70

PROPHYLACTICS AND CONTRACEPTIVES

855-070-0001

Definitions

(1) Prophylactic means a drug, device or medical preparation intended for or having special utility in the prevention of a sexually transmitted disease, or in the prevention of conception.

(2) Contraceptive means a drug, device or medical preparation intended for the prevention of conception.

(3) Male condom means a prophylactic or contraceptive device in the form of a sheath which completely covers the penis with a closely fitting membrane.

(4) Female condom means a prophylactic or contraceptive device in the form of an intravaginal pouch that consists of a sheath with a flexible ring on each end.

Stat. Auth.: ORS 689.155 & 689.205
Stats. Implemented:
Hist.: PB 1-1995, f. & cert. ef. 4-27-95

855-070-0005

Applications, Fees, and Licenses to Sell Prophylactics and Contraceptives

(1) Every wholesaler or manufacturer of prophylactics or contraceptives who distributes in Oregon goods of the class specified in ORS 435.010 shall annually submit an application for a license issued by the Board of Pharmacy:

(a) The application shall be made in writing on a form prepared by the Board and be accompanied by the fee listed in division 110;

(b) One such application shall be submitted and license obtained for each location or separate address from which goods are distributed;

(c) Licenses shall be issued upon receipt of the fee listed in division 110 and shall be in effect for one year from January 1 of each year. Licenses are not transferable;

(d) Licenses shall be publicly or conspicuously displayed and the wholesaler or manufacturer to whom they are issued shall be open to inspection by the Board or other authorized persons designated by the Board;

(e) Each application for a license shall include a list of all products or brands of prophylactics and contraceptives the applicant wishes to have approved for sale in the state.

(2) Before any condom product can be distributed in Oregon, it must be approved by the Oregon Board of Pharmacy. Every manufacturer or wholesaler that intends to distribute either male or female condoms shall furnish to the Board the names of such products.

(3) The Board may require proof to be furnished by the manufacturer or wholesaler that these products have received approval in accordance with the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR);

(4) The requirements under the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR) relating to prophylactics and contraceptives are adopted by reference and made a part hereof.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 435.010, 435.080, 435.100 & 689.155
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 29(Temp), f. & ef. 9-6-73; 1PB 32, f. 1-31-74, ef. 2-25-74; 1PB 35(Temp), f. & ef. 3-26-74; 1PB 36, f. 7-1-74, ef. 7-25-74; 1PB 39, f. & ef. 1-8-76; PB 10-1987, f. & ef. 12-8-87; PB 1-1995, f. & cert. ef. 4-27-95; BP 10-2006, f. & cert. et. 12-19-06

855-070-0010

Labeling and Storage of Prophylactics and Contraceptives

(1) The use of detachable slip labels or removable ink stamps listing names and addresses of manufacturer, brand name, and expiration date do not meet the labeling requirements of ORS 435.090.

(2) As of December 31, 1994, all prophylactics and contraceptives shall bear an expiration date. Prophylactics and contraceptives bearing an expiration date shall not be sold or otherwise distributed beyond that date.

(3) Prophylactics and contraceptives shall be stored, displayed, or sold from an area removed from excessive extremes of temperatures which may affect the quality of the products.

Stat. Auth.: ORS 689.155 & 689.205

Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 29(Temp), f. & ef. 9-6-73 thru 1-3-74; 1PB 32, f. 1-31-74, ef. 2-25-74; 1PB 39, f. & ef. 1-8-76; 1PB 1-1984, f. & ef. 2-16-84; PB 1-1995, f. & cert. ef. 4-27-95

The official copy of an Oregon Administrative Rule is contained in the Administrative Order filed at the Archives Division, 800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the published version are satisfied in favor of the Administrative Order. The Oregon Administrative Rules and the Oregon Bulletin are copyrighted by the Oregon Secretary of State. Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

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