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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: 8/16/1994 (Emer.), 3/1/1999, 10/19/2007
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: 8/28/2024
Prior Effective Dates: 12/15/1994, 3/1/2019
Rule 4729:5-8-03 | Compliance.
 

A nonresident terminal distributor of dangerous drugs shall:

(A) Maintain the following records of all dangerous drugs dispensed or personally furnished to persons in this state:

(1) Name, strength, dosage form, the serial number of the prescription, and quantity of the dangerous drug dispensed or personally furnished;

(2) Full name and date of birth of the patient for whom the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals; and

(3) Residential address, including the physical street address and, if provided, the telephone number of the patient or owner.

(B) Maintain the following records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code for drugs sold or transferred into this state: name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(C) Maintain all records and documents required by this chapter for a period of three years in a readily retrievable manner.

(D) Label all drugs dispensed or personally furnished into this state with the following minimum information:

(1) The name or "doing business as" (DBA) name, or other legal or contractually affiliated name and address of the terminal distributor.

(2) The full name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals.

(3) The full name of the prescriber or the first initial of the prescriber's first name and the full last name of the prescriber.

(4) Directions for use of the drug.

(5) The date of dispensing.

(6) Any cautions which may be required by federal or state law.

(7) The serial number of the prescription.

(8) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug dispensed, and the strength, if more than one strength of the drug is marketed.

(9) The quantity of drug dispensed.

(10) If the licensee is an institutional central fill pharmacy as defined in rule 4729:5-9-02.13 of the Administrative Code, the prescription label attached to the container shall contain the name and address of the originating pharmacy and the name of the central fill pharmacy. If applicable, the date on which the medication order was dispensed shall be the date on which the central fill pharmacy filled the order.

(11) If the licensee is a central fill pharmacy as defined in rule 4729:5-5-19 of the Administrative Code, the prescription label attached to the container shall contain the name and address of the originating pharmacy. The date on which the prescription was dispensed shall be the date on which the central fill pharmacy filled the prescription.

(a) If the originating pharmacy and the central fill pharmacy are not under common ownership, either of the following shall apply:

(i) The name of the central fill pharmacy shall be included on the prescription label or an auxiliary label; or

(ii) A statement is included on the prescription information accompanying the dangerous drug that indicates a central fill pharmacy was used to fill the prescription and includes the name of the central fill pharmacy.

(b) The originating pharmacy shall provide, upon the request of a patient or caregiver, the name and address of the central fill pharmacy and a contact phone number where the patient or caregiver can receive further assistance regarding prescriptions filled by a central fill pharmacy.

(E) Comply with all the statutory requirements of the state of Ohio set forth in Chapters 4729., 3719., 3715., and 2925. of the Revised Code for all drugs sold, dispensed or personally furnished into this state, unless the licensee can demonstrate that such compliance would cause the nonresident terminal distributor of dangerous drugs to violate either the statutory or regulatory requirements of the state in which it is located or federal statutory or regulatory requirements.

(F) Comply with the following regulatory requirements of the state of Ohio, unless the licensee can demonstrate that such compliance would cause the nonresident terminal distributor of dangerous drugs to violate either the statutory or regulatory requirements of the state in which it is located or federal statutory or regulatory requirements:

(1) The requirements set forth in this chapter;

(2) The requirements in Chapters 4729:5-1 and 4729:5-2 of the Administrative Code;

(3) Theft or significant loss reporting requirements in rule 4729:5-3-02 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(4) Inspection and corrective action requirements in rule 4729:5-3-03 of the Administrative Code;

(5) Licensure verification requirements in rule 4729:5-3-04 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(6) Patient confidentiality requirements in rule 4729:5-3-05 of the Administrative Code;

(7) Internet sales requirements in rule 4729:5-3-08 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(8) Occasional sale and drug transfer requirements in rule 4729:5-3-09 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(9) Remote medication order processing requirements in rule 4729:5-9-02.14 of the Administrative Code and remote outpatient prescription processing requirements in rule 4729:5-5-20 of the Administrative Code.

(10) The following central fill pharmacy requirements set forth in Chapters 4729:5-5 and 4729:5-9 of the Administrative Code:

(a) If the central fill pharmacy does not have the same owner as the originating pharmacy, the central fill pharmacy shall have a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law, rules and regulations. For central fill pharmacies dispensing outpatient prescriptions, the contract shall also expressly state who is responsible for performing the patient counseling requirements in accordance with paragraph (L) of this rule.

(b) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address, terminal distributor number, and, if applicable, drug enforcement administration registration number, for which it processes a request for the filling or refilling of a medication order or prescription received by the originating pharmacy.

(c) The central fill pharmacy and originating pharmacy shall have access to common electronic files as part of a real time, online database or have appropriate technology to allow secure access to sufficient information necessary or required to dispense or process the medication order or prescription.

(d) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems, and ensure compliance with this rule. The quality assurance plan shall be reviewed and updated annually.

(11) If engaged in the provision of medication therapy management, as defined in rule 4729:5-12-01 of the Administrative Code, for patients residing in this state the requirements set forth in Chapter 4729:5-12 of the Administrative Code.

(G) Submit to the applicable disciplinary actions set forth in section 4729.57 of the Revised Code and rule 4729:5-4-01 of the Administrative Code.

(H) Operate in compliance with all applicable laws, regulations and standards set forth by the United States food and drug administration and the United States drug enforcement administration.

(I) Nonresident terminal distributors of dangerous drugs who are pharmacies shall dispense prescriptions into this state issued by either:

(1) An Ohio prescriber who is authorized pursuant rule 4729:5-1-02 of the Administrative Code; or

(2) A nonresident prescriber whose license is current and in good standing and who is authorized to issue prescriptions for dangerous drugs in the course of the prescriber's professional practice in a state other than Ohio.

(J) 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.

(K) 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.

(L) 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.

(M) Nonresident terminal distributors shall permit properly identified and authorized state board of pharmacy agents and federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles. A nonresident terminal distributor of dangerous drugs shall be responsible for all costs incurred by board of pharmacy agents in conducting an inspection. Upon completion of the inspection, the nonresident terminal distributor of dangerous drugs shall have ninety days to reimburse all inspection costs incurred after being notified, electronically or in writing, by the board.

In lieu of an inspection by the board, a nonresident terminal distributor of dangerous drugs may submit any of the following:

(1) Inspection reports by a state licensing agency demonstrating compliance with the requirements of this rule.

(2) Inspection reports demonstrating compliance with the requirements of this rule by one of the following organizations:

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

(b) An organization approved by the board.

(N) Comply with all drug database reporting requirements pursuant to Chapter 4729. of the Revised Code and division 4729:8 of the Administrative Code.

(O) Unless approved by the board's executive director, a nonresident terminal distributor of dangerous drugs that is not a pharmacy shall not be permitted to sell or personally furnish controlled substances to patients residing in this state.

Last updated February 1, 2022 at 9:18 AM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.551, 4729.54, 4729.55
Five Year Review Date: 2/1/2027
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
Prior Effective Dates: 5/1/2015
Rule 4729:5-8-05 | Preparation, compounding, dispensing, and repackaging of radiopharmaceuticals by a nonresident pharmacy.
 

(A) Except as otherwise provided in this rule, terms used in this rule have the same meaning as in rule 4729:5-6-01 of the Administrative Code.

(B) Only a pharmacy licensed as a nonresident terminal distributor of dangerous drugs may dispense or sell patient-specific radiopharmaceuticals into this state and shall comply with all the following:

(1) All radiopharmaceuticals shall be dispensed pursuant to a patient-specific prescription or order issued by a licensed health professional authorized to prescribe drugs.

(a) A limited quantity may be prepared and distributed in anticipation of prescriptions based on routine, regularly observed prescribing patterns.

(b) In the event a patient's name is not available at the time of dispensing, a nonresident nuclear pharmacy shall have up to seventy-two hours to obtain the name of the patient. No later than seventy-two hours after dispensing the radiopharmaceutical, the patient's name must be associated with the prescription in the dispensing records maintained by the nonresident pharmacy.

(2) Comply with the requirements of USP <825>.

(3) Shall have an authorized nuclear pharmacist licensed in this state as its responsible person. The requirement for the responsible person to obtain Ohio licensure shall take effect on June 30, 2022.

(C) Radiopharmaceuticals shall be labeled in accordance with USP <825>.

(1) In addition to the requirements in paragraph (C) of this rule, the outer shielding shall also be labeled with the following:

(a) The name and telephone number of the pharmacy;

(b) The prescription number; and

(c) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(2) In addition to the requirements in paragraph (C) of this rule, the immediate container shall also be labeled with the following information:

(a) The prescription number; and

(b) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(D) A pharmacy licensed as a nonresident terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the proper labeling, environmental controls, integrity, and safety of all products transported.

(E) A pharmacy licensed as a nonresident terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the disposal of radioactive and/or biohazardous waste in a manner so as not to endanger the health and safety of the public.

(F) A terminal distributor shall report any event as a medical event, except for an event that results from patient intervention, to the United States nuclear regulatory commission in accordance with 10 CFR 35.3045 (6/2/2020).

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

(H) If a pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or their license has lapsed, the pharmacy shall 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 USP <825> 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 USP <825> rule by the national association of boards of pharmacy's verified pharmacy program; or

(3) Any other documentation of compliance as determined by the state board of pharmacy.

(I) This rule does not apply to a pharmacy licensed as a nonresident terminal distributor of dangerous drugs that prepares compounded drug preparations in accordance with rule 4729:5-8-04 of the Administrative Code.

Last updated February 1, 2022 at 9:18 AM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.54, 4729.55
Five Year Review Date: 2/1/2027