5101:3-9-07 Drug review process.

(A) For a drug to be considered for inclusion in appendix A to rule 5101:3-9-12 of the Administrative Code, the following information may be requested from the manufacturer or labeler:

(1) Trade name of the drug.

(2) Generic name of the drug.

(3) National drug code number (NDC).

(4) Package sizes available.

(5) Strengths.

(6) Therapeutic use(s).

(7) List of therapeutic ingredients.

(8) Direct, average wholesale price, and wholesale acquisition cost.

(9) Bioavailability and bioequivalency data.

(10) Letter(s) of approval of new drug application (NDA), or abbreviated new drug application (ANDA).

(11) Product labeling as approved by the food and drug administration.

(12) A statement of justification for inclusion in appendix A to rule 5101:3-9-12 of the Administrative Code including cost effectiveness and relative merits.

(B) Final determination by ODJFS of a drug's inclusion on or removal from appendix A to rule 5101:3-9-12 of the Administrative Code will be based on a review and analysis of the information required in paragraph (A) of this rule in addition to an analysis of such factors as:

(1) Specific attributes and/or benefits of the drug.

(2) Availability and cost effectiveness of the drug in relation to alternative products.

(3) Availability of bioequivalent generic products.

(4) Provision of a supplemental rebate payment for a drug that reduces the acquisition cost.

Effective: 07/24/2008
R.C. 119.032 review dates: 04/24/2008 and 07/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01, 5111.02
Prior Effective Dates: 4/7/77, 9/19/77, 12/21/77, 12/30/77, 7/8/78, 10/1/78, 5/9/86, 11/1/86, 10/1/87, 2/1/88, 1/13/89 (Emer), 4/13/89, 6/1/89, 7/1/94, 10/1/97, 2/3/00 (Emer), 5/1/00, 8/30/01, 3/31/03 (Emer), 6/12/03