(A) Each prescriber, terminal distributor of dangerous drugs, or wholesale 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 prescriber, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs:
(1) The state board of pharmacy, by telephone 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(b)(1/21/2016);
(B) Controlled substance thefts must also be reported by using the federal DEA report form whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them. A copy of the federal form regarding such theft or loss shall be filed with the state board of pharmacy within thirty days following the discovery of such theft or 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 writing.
(C) Each prescriber, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs immediately upon discovery of any theft or loss of:
(1) 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, shall notify the state board of pharmacy and law enforcement authorities.
(2) Official written order form(s) as defined in division (Q) of section 3719.01 of the Revised Code shall notify the state board of pharmacy and law enforcement authorities, and the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1305.12(b)(1/21/2016).
Five Year Review (FYR) Dates: 11/17/2017
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.07, 4729.55
Prior Effective Dates: 04/01/1978, 02/15/1982, 07/01/1990, 02/15/1995, 01/17/1997, 03/01/1999, 01/01/2006, 01/01/2011, 04/28/2016