Ohio Code 4729.78 – Drug database information reporting
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each manufacturer of dangerous drugs, outsourcing facility, repackager of dangerous drugs, or wholesale distributor of dangerous drugs that delivers drugs to prescribers or terminal distributors of dangerous drugs shall submit to the board the following purchase information:
Terms Used In Ohio Code 4729.78
- Another: when used to designate the owner of property which is the subject of an offense, includes not only natural persons but also every other owner of property. See Ohio Code 1.02
- Drug: means :
(1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(2) Any other article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(3) Any article, other than food, intended to affect the structure or any function of the body of humans or animals;
(4) Any article intended for use as a component of any article specified in division (E)(1), (2), or (3) of this section; but does not include devices or their components, parts, or accessories. See Ohio Code 4729.01
- manufacturer: means a person, other than a pharmacist or prescriber, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs. See Ohio Code 4729.01
- Outsourcing facility: means a facility that is engaged in the compounding and sale of sterile drugs and is registered as an outsourcing facility with the United States food and drug administration. See Ohio Code 4729.01
- Person: includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the state, and any district, department, or agency of the state or its political subdivisions. See Ohio Code 4729.01
- repackager: means a person that repacks and relabels dangerous drugs for sale or distribution. See Ohio Code 4729.01
- state: means the state of Ohio. See Ohio Code 1.59
- wholesale distributor: means a person engaged in the sale of dangerous drugs at wholesale and includes any agent or employee of such a person authorized by the person to engage in the sale of dangerous drugs at wholesale. See Ohio Code 4729.01
(1) Purchaser identification;
(2) Identification of the drug sold;
(3) Quantity of the drug sold;
(4) Date of sale;
(5) The license number issued by the board.
(B)(1) The information shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(2) The information shall be submitted electronically in the format specified by the board, except that the board may grant a waiver allowing submission of the information in another format.
(3) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:
(a) The manufacturer, outsourcing facility, repackager, or wholesale distributor suffers a mechanical or electronic failure, or cannot meet the deadline for other reasons beyond the person‘s control.
(b) The board is unable to receive electronic submissions.