Or. Admin. Code § 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.

Notes

Or. Admin. Code § 855-070-0005

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

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 435.010, 435.080, 435.100 & 689.155