Lawriter - OAC - 4729:5-8-03. Compliance

4729:5-8-03. Compliance

A nonresident terminal distributor of dangerous drugs shall:

(A) Maintain, in readily retrievable manner, records of all dangerous drugs sold at retail to persons in Ohio for a minimum of three years.
(B) Comply with all the statutory and regulatory requirements of the state of Ohio for controlled substances, including those that are different from federal law, unless such compliance would cause the nonresident terminal distributor of dangerous drugs to violate the statutory or regulatory requirements of the state in which it is located.
(C) Comply with all statutory and regulatory requirements of the state of Ohio for the compounding of dangerous drugs, including those that are different from federal law, unless such compliance would cause the nonresident terminal distributor of dangerous drugs to violate the statutory or regulatory requirements of the state in which it is located.
(D) Supply, within three business days of a request, all information needed by the board of pharmacy to carry out its responsibilities as a licensing, regulatory, and drug law enforcement agency of the state of Ohio.
(E) Supply, within three business days of a request, all information needed by the board of pharmacy and any local, state, or federal agency to carry out its responsibilities in enforcing the federal and state laws governing the distribution of drugs in the state of Ohio.
(F) If the nonresident terminal distributor is a pharmacy, there must be an offer to counsel the patient issued with every prescription dispensed. The offer shall be made by telephone or in writing on a separate document and shall accompany the prescription. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population. The pharmacy shall have sufficient telephone service to provide access to incoming callers.
(G) Facilities and records of nonresident terminal distributors of dangerous drugs shall be subject to inspection by board of pharmacy agents and Ohio drug law enforcement agencies.
(1) Inspection reports by a state licensing agency may be accepted in lieu of inspection by the board.
(2) Inspection reports by one of the following may be accepted in lieu of inspection by the board:
(a) The national association of boards of pharmacy's verified pharmacy program (VIPP);
(b) An organization approved by the board.
(H) Comply with all drug database reporting requirements pursuant to Chapter 4729. of the Revised Code and all rules adopted thereunder.

Replaces: 4729-10-03


Cite as Ohio Admin. Code 4729:5-8-03

History. Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.551, 4729.544729.55
Prior Effective Dates: 08/16/1994 (Emer.), 12/15/1994, 10/19/2007