4729-8-01 Definitions.

As used in Chapter 4729-8 of the Administrative Code:

(A) "Authorized collector" means a registered manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy that is authorized by the United States drug enforcement administration to receive controlled substances for the purpose of destruction.

(B) "Controlled substances" has the same meaning as defined in division (C) of section 3719.01 of the Revised Code.

(C) "Dangerous drugs" has the same meaning as defined in division (F) of section 4729.01 of the Revised Code.

(D) "Drug collection receptacle" means a secured, lined receptacle into which prescription medications, including controlled substances, dangerous drugs, and over-the-counter medications can be deposited by ultimate users for the purposes of collecting unused or expired drugs. Except for a law enforcement agency, a drug collection receptacle shall meet the requirements specified in 21 CFR 1317.75 (10/09/2014).

(E) "Drug" has the same meaning as defined in division (E) of section 4729.01 of the Revised Code.

(F) "Law enforcement agency" means a government entity that employs peace officers to perform law enforcement duties or a federal law enforcement agency.

(G) "Law enforcement officer" has the same meaning as 21 CFR 1300.05 (10/09/2014).

(H) "Mail-back program" means a program operated by an authorized collector or law enforcement agency that accepts prescription medications, including controlled substances, dangerous drugs, and over-the-counter medications from ultimate users through the mail for purposes of collecting unused or expired drugs. Except for a law enforcement agency, a mail-back program shall meet the requirements specified in 21 CFR 1317.70 (10/09/2014).

(I) "Non-retrievable" means the condition or state to which a drug shall be rendered following a process that permanently alters that drug's physical or chemical condition or state through irreversible means and thereby renders the drug unavailable and unusable for all practical purposes.

(J) "Take-back event" means a one-day program operated by a law enforcement agency through which ultimate users may safely dispose of unused or expired prescription medications, including controlled substances, dangerous drugs, and over-the-counter medications. A take-back event shall meet the requirements specified in 21 CFR 1317.65 (10/09/2014).

(K) "Ultimate user" means a person who has lawfully obtained, and who possesses, a pharmaceutical drug for their own use or for the use of a member of their household or for an animal owned by an individual or a member of their household. It also includes any person lawfully entitled to dispose of a decedent's property.

Replaces: 4729-8-01

Cite as Ohio Admin. Code 4729-8-01

Effective: 3/23/2015
Five Year Review (FYR) Dates: 03/23/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 4729.69, 3719.28
Rule Amplifies: 4729.01, 4729.51
Prior Effective Dates: 10/24/14