Skip to main content
Back To Top Top Back To Top
This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:5-8 | Non-resident Pharmacies

 
 
 
Rule
Rule 4729:5-8-01 | Definitions.
 

As used in Chapter 4729:5-8 of the Administrative Code:

(A) "Nonresident terminal distributor of dangerous drugs" or "nonresident terminal distributor" means any person located outside of Ohio that ships, mails, or delivers in any manner, dangerous drugs at retail into Ohio. A nonresident terminal distributor of dangerous drugs shall maintain a license in accordance with sections 4729.54 and 4729.55 of the Revised Code and shall comply with all requirements set forth in this chapter. A nonresident terminal distributor does not include a person shipping drugs into this state for destruction or disposal by an Ohio licensed reverse distributor.

(B) "Dangerous drug" has the same meaning as defined in section 4729.01 of the Revised Code.

(C) "Licensed health professional authorized to prescribe drugs" or "prescriber" means an individual who is authorized by law to prescribe drugs or dangerous drugs in the state where the individual is practicing.

(D) "Pharmacist," as used in division (B) of section 4729.55 of the Revised Code, means an individual who holds a current license to practice pharmacy in the state where the individual is practicing.

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

(F) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.01
Five Year Review Date: 3/1/2024
Prior Effective Dates: 12/15/1994, 5/22/2014
Rule 4729:5-8-02 | Licensure.
 

(A) A person seeking a license as a nonresident terminal distributor of dangerous drugs shall submit an application to the state board of pharmacy that includes all of the following:

(1) Information necessary to demonstrate the qualifications for licensure set forth in section 4729.55 of the Revised Code.

(2) If the applicant's facility maintains a current license in the state where it is located, all the following:

(a) Certification from the appropriate state licensing agency that the applicant maintains at all times a valid, unexpired license, permit, or registration authorizing the possession and sale of dangerous drugs in the state in which the facility is located and from where dangerous drugs are being sold at retail to residents in Ohio. The certification(s) shall include licenses, permits, or registrations required to cover the categories of dangerous drugs which the nonresident terminal distributor of dangerous drugs will be selling at retail to persons in the state of Ohio.

(b) A copy of the most recent inspection report, any warning notices, notice of deficiency reports, or any other related reports issued by a state licensing agency and drug law enforcement agencies of the state in which it is located or any federal agencies regulating and enforcing laws governing the legal distribution of drugs.

(3) Any other information as determined by the board.

(B) A nonresident terminal distributor shall have a responsible person that complies with the requirements of rule 4729:5-2-01 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.55, 4729.54, 4729.57, 4729.551
Five Year Review Date: 3/1/2024
Prior Effective Dates: 8/16/1994 (Emer.), 12/15/1994
Rule 4729:5-8-03 | Compliance.
 

A nonresident terminal distributor of dangerous drugs shall:

(A) Maintain, in readily retrievable manner, records of all dangerous drugs sold at retail to persons in Ohio for a minimum of three years.

(B) Comply with all the statutory and regulatory requirements of the state of Ohio for controlled substances, including those that are different from federal law, unless such compliance would cause the nonresident terminal distributor of dangerous drugs to violate the statutory or regulatory requirements of the state in which it is located.

(C) Comply with all statutory and regulatory requirements of the state of Ohio for the compounding of dangerous drugs, including those that are different from federal law, unless such compliance would cause the nonresident terminal distributor of dangerous drugs to violate the statutory or regulatory requirements of the state in which it is located.

(D) Supply, within three business days of a request, all information needed by the board of pharmacy to carry out its responsibilities as a licensing, regulatory, and drug law enforcement agency of the state of Ohio.

(E) Supply, within three business days of a request, all information needed by the board of pharmacy and any local, state, or federal agency to carry out its responsibilities in enforcing the federal and state laws governing the distribution of drugs in the state of Ohio.

(F) If the nonresident terminal distributor is a pharmacy, there must be an offer to counsel the patient issued with every prescription dispensed. The offer shall be made by telephone or in writing on a separate document and shall accompany the prescription. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population. The pharmacy shall have sufficient telephone service to provide access to incoming callers.

(G) Facilities and records of nonresident terminal distributors of dangerous drugs shall be subject to inspection by board of pharmacy agents and Ohio drug law enforcement agencies.

(1) Inspection reports by a state licensing agency may be accepted in lieu of inspection by the board.

(2) Inspection reports by one of the following may be accepted in lieu of inspection by the board:

(a) The national association of boards of pharmacy's verified pharmacy program (VIPP);

(b) An organization approved by the board.

(H) Comply with all drug database reporting requirements pursuant to Chapter 4729. of the Revised Code and all rules adopted thereunder.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.551, 4729.54 4729.55
Five Year Review Date: 3/1/2024
Prior Effective Dates: 8/16/1994 (Emer.)
Rule 4729:5-8-04 | Drugs compounded by a nonresident pharmacy.
 

(A) Except as otherwise provided in this rule, the terms and references used in this rule have the same meaning as in rules 4729:7-1-01 and 4729:7-2-01 of the Administrative Code.

(B) For all non-sterile compounded drug preparations, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <795>. The requirements of this rule do not apply to the preparation of non-hazardous, conventionally manufactured non-sterile products in accordance with the directions contained in the approved labeling provided by the product's manufacturer.

(C) For all sterile compounded drug preparations, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <797>.

(D) For all antineoplastic compounded hazardous drug preparations listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <800>.

(E) For all non-antineoplastic compounded hazardous drug preparations listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code and for all compounded hazardous drug preparations listed in table two or three on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with either:

(1) United States pharmacopeia chapter <800>; or

(2) All the following:

(a) Conduct a risk assessment for any hazardous drug preparations listed in paragraph (E) of this rule to determine if any additional containment strategies, work practices, and/or training is required to minimize occupational exposure. Risk assessments shall be made readily retrievable for review by an agent, inspector or employee of the state board of pharmacy. The risk assessment must be reviewed at least every twelve months and the review documented. If a risk assessment is not performed, the compounded drug preparations shall be prepared in accordance with paragraph (E)(1) of this rule. The risk assessment must, at a minimum, consider the following:

(i) Type of hazardous drug (e.g., non-antineoplastic or reproductive risk only);

(ii) Dosage form;

(iii) Risk of exposure;

(iv) Packaging; and

(v) Manipulation.

(b) Ensure that any employees of reproductive capability confirm in writing that they understand the potential risks of handling drugs listed in paragraph (E) of this rule.

(F) In addition to the labeling requirements set forth in this rule, the statement "Compounded Drug" or other similar statement shall be displayed prominently on the label of all compounded drug preparations sold in this state.

(G) A pharmacy licensed as a nonresident terminal distributor of dangerous drugs that engages in drug compounding shall comply with the following:

(1) Except as provided in paragraph (G)(2) of this rule, shall not sell, ship, mail, or deliver, in any manner, compounded drugs into Ohio unless it is pursuant to a patient specific prescription.

(2) May sell, ship, mail, or deliver, in any manner, non-patient specific compounded drugs for animal use pursuant to rule 4729:7-2-04 of the Administrative Code. Such compounding for office use shall comply with applicable federal laws and regulations.

(3) A pharmacy licensed as a non-resident pharmacy that is engaged in drug compounding shall have an Ohio licensed pharmacist as the responsible person on its license. This provision shall take effect on August 1, 2021.

(H) If a pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or the pharmacy's license has lapsed, the pharmacy must provide any of the following, in a manner determined by the board, as part of the initial or renewal application:

(1) The most recent inspection report that is less than two years old that demonstrates applicable compliance with 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;

(2) The most recent inspection report that is less than two years old that demonstrates applicable compliance with this rule by the national association of boards of pharmacy's verified pharmacy program;

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

(4) Proof of a current pharmacy compounding accreditation board (PCAB) accreditation provided by the accreditation commission for health care (ACHC); or

(5) Proof of a current medication compounding certification from the joint commission.

(I) A pharmacy licensed as a nonresident terminal distributor shall report to the state board of pharmacy within seventy-two hours upon discovery, and in a manner determined by the board, any product quality issue attributed to a compounded drug preparation dispensed by the pharmacy.

(1) As used in this paragraph, a product quality issue means any of the following:

(a) Any incident that causes the compounded drug preparation or its labeling to be mistaken for, or applied to, another article;

(b) Contamination of the compounded drug preparation, including but not limited to mold, fungal, bacterial, or particulate contamination; or

(c) Any significant chemical, physical, or other change or deterioration of the dispensed compounded drug preparation within the compounded drug preparation's assigned beyond use date.

(2) A product quality issue does not include an isolated allergic reaction to a substance included in a compounded drug preparation.

(J) A pharmacy licensed as a nonresident terminal distributor shall report to the state board of pharmacy within seventy-two hours of issuance or receipt, and in a manner determined by the board, any warning letters, injunctions, or decrees issued in relation to the pharmacy by the United States food and drug administration.

(K) This rule does not apply to a pharmacy licensed as a nonresident terminal distributor of dangerous drugs that prepares radiopharmaceuticals as defined in agency 4729 of the Administrative Code.

Last updated July 1, 2021 at 11:12 AM

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.54, 4729.55, 4729.01
Five Year Review Date: 7/1/2026