Ohio Admin. Code 4729:6-10-02 - Outsourcing facilities - recordkeeping
(A) Outsourcing facilities shall establish
and maintain inventories and records of all transactions regarding the
compounding, manufacturing, sale, receipt, and
distribution or other disposition of dangerous drugs.
(1) The records shall include, but not be
limited to, the following information:
(a) The
source of the drugs, including the name and principle
principal
address of the seller or transferor, and the address of the location from which
the drugs were shipped.
(b) The
name, formulation (i.e., active ingredients),
dosage form, and quantity of the drugs received,
distributed, sold, disposed, or
returned.
(c) The dates of receipt,
sale, and distribution of the drugs.
(d) The name and principle
principal
address of the purchaser or receiver and the address of the location where the
drugs were shipped.
(e) A system of
records and procedures shall be maintained which prevent the sale or other
distribution of dangerous drugs to any person not authorized in accordance with
section 4729.51 of the Revised Code.
Such procedures and records shall meet the requirements set forth in rule
4729:6-3-04 of the
Administrative Code.
(2)
All records maintained in accordance with this rule shall be made readily
retrievable for inspection and copying by properly identified and authorized
state board of pharmacy agents and federal, state, or local law enforcement
agency officials for a period of five years following disposition of the
drugs.
(3) Outsourcing facilities
located in this state intending to maintain records at a location other than
the place licensed by the state board of pharmacy must notify the board in a
manner determined by the board. Any such alternate location shall be secured
and accessible only to representatives or contractors of the outsourcing
facility.
(4) An outsourcing
facility maintaining records at location other than the location licensed by
the state board of pharmacy or via a computerized recordkeeping system shall
maintain an executed agreement with the company possessing or storing the
records authorizing an agent of the board access to the records maintained in
accordance with this division within three business days.
(B) The recordkeeping requirements in
paragraph (A) of this rule shall be followed for all damaged, deteriorated,
misbranded, or adulterated dangerous drugs.
(C) Outsourcing facilities shall submit
applicable wholesale or retail sale information to the drug database in
accordance with section
4729.78 of the Revised
Code.
(D) Outsourcing facilities
shall comply with all recordkeeping requirements pursuant to section 503B of
the Federal Food, Drug, and Cosmetic Act (5/28/2015).
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.52
Prior Effective Dates: 03/01/2019, 03/01/2021
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.