Lawriter - OAC - 4729:5-3-02. Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents

4729:5-3-02. Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents

(A) A terminal distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the licensed location:
(1) The state board of pharmacy, by telephone or other method determined by the board, immediately upon discovery of the theft or significant loss;
(2) If a controlled substance, the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1301.76 (1/21/2016);
(3) Law enforcement authorities pursuant to section 2921.22 of the Revised Code.
(B) The theft or significant loss of controlled substances shall be reported by a licensee using the federal DEA report form regardless if the controlled substances are subsequently recovered and/or the responsible parties are identified and action is taken. Information reported in the federal form regarding such theft or significant loss shall be filed with the state board of pharmacy, in a manner determined by the board, by the licensee within thirty days following the discovery of such theft or significant loss.
(1) An exemption may be obtained upon sufficient cause if the federal form cannot be filed within thirty days.
(2) A request for a waiver of the thirty-day limit must be requested in a manner determined by the board.
(C) The theft or significant loss of non-controlled dangerous drugs shall be reported to the state board of pharmacy, in a manner determined by the board, by the licensee within thirty days following the discovery of such theft or significant loss of non-controlled dangerous drugs. The report shall be filed regardless if the dangerous drugs are subsequently recovered and/or the responsible parties are identified and action is taken.
(1) An exemption may be obtained upon sufficient cause if the form cannot be filed within thirty days.
(2) A request for a waiver of the thirty-day limit must be requested in a manner determined by the board.
(D) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, and law enforcement authorities of any theft or loss of uncompleted prescription blank(s) used for writing a prescription, written prescription order(s) not yet dispensed and original prescription order(s) that have been dispensed.
(E) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, law enforcement authorities and the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1305.12 (1/21/2016) of the theft or loss of any official written order form(s) as defined in division (Q) of section 3719.01 of the Revised Code.

Replaces: 4729-9-15


Cite as Ohio Admin. Code 4729:5-3-02

History. Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 3719.07, 4729.55
Prior Effective Dates: 4/1/78, 02/15/1982, 07/01/1990, 02/15/1995, 01/17/1997, 03/01/1999, 01/01/2006, 01/01/2011