(A) As used in this rule:
(1) "Customer"
means a person located in this state that orders or seeks to order a reported
drug from an Ohio licensed drug distributor and includes the
following:
(a) A licensed terminal distributor of dangerous drugs;
or
(b) A prescriber who possesses, or possesses for sale or
sells, at retail, a dangerous drug.
(2) "Prescriber" has the same meaning as in
section 4729.01 of the Revised Code.
(3) "Reported
drug" means any dangerous drug whose sale is required to be reported to
the drug database pursuant to division 4729:8 of the Administrative Code. A
reported drug shall not include any list I or list II chemicals listed in 21
CFR Section 1310.02 (10/31/2023).
(B) This rule only applies to the
following drug distributors licensed in accordance with section 4729.52 of the
Revised Code:
(1) Wholesale
distributors of dangerous drugs;
(2) Virtual
wholesalers;
(3) Manufacturers of
dangerous drugs; and
(4) Outsourcing
facilities.
(C) Drug distributors listed in paragraph
(B) of this rule shall design and operate a system to identify and report
suspicious orders by customers for reported drugs. Suspicious orders shall
include, but are not limited to, the following:
(1) Orders of unusual
size;
(2) Orders deviating
substantially from a normal pattern; and
(3) Orders of unusual
frequency.
(D) Prior to any shipment of an order
that a distributor has identified as suspicious, two persons designated by the
distributor's responsible person must independently analyze the order. In
order to proceed with the shipment and complete the sale, each of the two
people designated must determine that the order is not likely to be diverted
from legitimate channels.
(E) All suspicious orders, regardless of
actual sale, shall be submitted electronically in a manner and format
determined by the board. The electronic submission of suspicious orders shall
include all information as required by the board and shall be submitted within
five days of the order being identified as suspicious by the drug
distributor.
(F) All drug distributors listed in
paragraph (B) of this rule shall submit a zero report, in a manner determined
by the board, if no suspicious orders have been identified by the distributor
in a calendar month. The zero report shall be submitted within fifteen days of
the end of the calendar month.
(G)
(1) Except as provided in
paragraph (G)(2) of this rule, a drug distributor listed in paragraph (B) of
this rule shall exercise due diligence to identify customers ordering or
seeking to order reported drugs to establish the normal and expected
transactions conducted by those persons and to identify and prevent the sale of
reported drugs that are likely to be diverted from legitimate channels. Such
measures shall include, but are not limited to, the following which shall be
conducted prior to an initial sale and on an annual basis:
(a) Questionnaires and affirmative steps by the drug
distributor to confirm the accuracy and validity of the information
provided.
(b) For a customer who is a prescriber, confirmation of
prescriber type (physician, dentist, veterinarian, etc.), specialty practice
area (oncology, geriatrics, pain management, etc.) and if the prescriber
personally furnishes reported drugs and the quantity personally
furnished.
(c) Review of drug utilization reports.
(d) Obtaining and conducting a review of the following
information:
(i) The methods of
payment accepted (cash, insurance, medicaid, medicare) and in what
ratios;
(ii) The ratio of
controlled vs. non-controlled drug orders and overall sales;
(iii) Orders for reported
drugs from other drug distributors made available by the United States drug
enforcement administration's automation of reports and consolidated orders
system; and
(iv) The proportion of
out-of-state patients served compared to in-state patients.
(2) A drug distributor
receiving a request for an initial sale for a reported drug may conduct the
sale without complying with paragraph (G)(1) of this rule if all the following
applies:
(a) The sale is to an institutional facility as defined in
Chapter 4729:5-9 of the Revised Code that is a new customer of the
distributor;
(b) The drug distributor documents that the order is to
meet an emergent need; and
(c) The drug distributor completes the requirements set
forth in paragraph (G)(1) of the rule no later than sixty days from the date of
sale.
(H) Any customer that may be engaging in
possible activities that may cause reported drugs to be diverted from
legitimate channels, including those to whom a drug distributor refuses to
sell, shall be electronically reported by the drug distributor in a manner and
format determined by the board. The electronic submission of such customers
shall include all information as required by the board and shall be submitted
within five days of refusal, cessation or identification by the drug
distributor.
(I) All drug distributors described in paragraph (B) of
this rule shall maintain and implement policies and procedures that include all
the following:
(1) The design and
operation of a suspicious order monitoring and reporting system.
(2) A system to collect
the necessary information on customers in accordance with paragraph (G) of this
rule.
(3) Mandatory training,
to be conducted annually, for staff responsible for the processing of all
orders for reported drugs that includes all the following:
(a) The drug distributor's suspicious order monitoring
system;
(b) The process to collect all relevant information on
customers in accordance with paragraph (G) of this rule;
(c) The process for submission of suspicious orders and
customers who may be engaging in possible activities that may cause reported
drugs to be diverted from legitimate channels to the board; and
(d) Information on submitting a confidential report of a
suspicious order or customer engaging in possible activities that may cause
reported drugs to be diverted from legitimate channels by using the
board's online electronic complaint form that can accessed by visiting:
www.pharmacy.ohio.gov. The training shall remind all employees that complaints
and all information submitted that identifies a complainant shall remain
confidential pursuant to section 4729.23 of the Revised Code.
(J) All policies and procedures maintained in accordance
with paragraph (I) of this rule shall be reviewed and updated on an annual
basis.
