4729-16-08 Drugs compounded by a nonresident pharmacy.

(A) For all non-sterile compounded drug products, the pharmacy shall comply with chapter <795> of the United States pharmacopeia, USP 38 - NF 33, or any official supplement thereto (09/01/2015).

(B) For all sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (09/01/2015).

(C) A nonresident pharmacy may provide licensed veterinarians non-patient specific compounded drugs for animal use, pursuant to rule 4729-16-12 of the Administrative Code. Such compounding for office use shall comply with applicable federal laws and regulations.

(D) Except as provided in paragraph (C) of this rule, a nonresident pharmacy as defined in rule 4729-16-01 of the Administrative Code is prohibited from shipping compounded drugs into Ohio unless it is pursuant to a patient specific prescription.

(E) A nonresident pharmacy as defined in rule 4729-16-01 of the Administrative Code shall meet all of the following in order to ship, mail, or deliver, in any manner, compounded drugs into Ohio:

(1) Obtain licensure as a nonresident terminal distributor of dangerous drugs pursuant to Chapter 4729-10 of the Administrative Code.

(2) If the nonresident pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or their license has lapsed, they must provide one of the following, in a manner prescribed by the board, with their application:

(a) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule conducted by an agent of the regulatory or licensing agency in the pharmacy's resident jurisdiction or an agent of a regulatory or licensing agency from another licensing jurisdiction; or

(b) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule by the national association of boards of pharmacy's verified pharmacy program as defined in rule 4729-16-01 of the Administrative Code;

(c) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule conducted by accreditation commission for health care inspection services (a.k.a. ACHC inspection services or AIS); or

(d) Proof of a current pharmacy compounding accreditation board (PCAB) accreditation provided by the accreditation commission for health care (ACHC).

(F) Notwithstanding submission of an inspection report from a source acceptable to the board, the board may deny an application or suspend a license on the grounds that the nonresident pharmacy failed to comply with applicable laws or regulations. The nonresident pharmacy would have the opportunity for a hearing before the board.

(G) The board may grant a one-year, one-time extension to nonresident pharmacies in the event an inspection report is not available at the time of application or renewal and documentation is presented verifying intent to comply with this rule.

(H) A nonresident pharmacy is required to report to the state board of pharmacy immediately upon discovery, by telephone and follow-up in writing within thirty days, any of the following:

(1) A violation of section 4729.16 of the Revised Code or any other violation of the Ohio Revised Code or Ohio Administrative Code that could potentially cause patient harm;

(2) A citation or violation against the nonresident pharmacy or the owner(s), responsible person, agent, employee or officer of the nonresident pharmacy by any pharmacy regulatory or licensing agency that results in any the following:

(a) Monetary penalty;

(b) Administrative hearing;

(c) Suspension or revocation of a license; or

(d) Violations of laws or regulations that could potentially cause patient harm.

(3) Any criminal conviction(s) of the owner(s), responsible person, agent, employee or officer of the nonresident pharmacy.

(4) Any adverse event related to improper compounding or product defect.

(I) Failure to report the required information in paragraph ( H) of this rule may result in a monetary penalty and/or the suspension, revocation, or refusal to grant or renew a license as a terminal distributor of dangerous drugs.

(J) This rule does not apply to a nuclear pharmacy that compounds radiopharmaceuticals pursuant to rule 4729-15-01 of the Administrative Code.

Cite as Ohio Admin. Code 4729-16-08

Effective: 2/15/2016
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.54, 4729.55, 4729.01
Prior Effective Dates: 5/1/2015