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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:3-3 | Practice

 
 
 
Rule
Rule 4729:3-3-01 | Pharmacy Technician Trainees.
 

(A) A pharmacy technician trainee shall wear a name tag or badge which contains the designation "Pharmacy Technician Trainee." The required designation may be added to an existing name tag or badge. The name tag or badge and the required designation shall contain lettering of a legible size.

(B) A pharmacy technician trainee may, under the direct supervision of a pharmacist, engage in the following activities at a location licensed as a terminal distributor of dangerous drugs to the extent that the activities do not require the exercise of professional judgment:

(1) Accepting new written, faxed or electronic prescription orders from a prescriber or a prescriber's agent but shall not include verbal orders;

(2) Entering information into and retrieving information from a database or patient profile;

(3) Preparing and affixing labels;

(4) Stocking dangerous drugs and retrieving those drugs from inventory;

(5) Counting and pouring dangerous drugs into containers;

(6) Placing dangerous drugs into containers prior to dispensing by a pharmacist;

(7) Non-sterile drug compounding following the completion of site-specific training pursuant to rule 4729:3-3-02 of the Administrative Code;

(8) Sterile drug compounding following the completion of a site-specific training pursuant to rule 4729:3-3-02 of the Administrative Code;

(9) Packaging and selling a dangerous drug to a patient or patient representative; and

(10) Sending or receiving electronic prescriptions between pharmacies accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner.

(C) A pharmacist is not permitted to supervise more than three pharmacy technician trainees engaging in the activities pursuant to paragraph (B) of this rule at any time, unless otherwise approved by the board.

(D) The number of pharmacy technician trainees supervised by a pharmacist does not limit the number of pharmacy interns that can be supervised by a pharmacist in accordance with rule 4729:2-1-01 of the Administrative Code.

Last updated September 11, 2023 at 11:41 AM

Supplemental Information

Authorized By: 4729.26, 4729.94
Amplifies: 4729.90, 4729.96, 4729.95, 4729.94, 4729.93, 4729.921, 4729.92, 4729.91, 4729.901
Five Year Review Date: 4/27/2026
Rule 4729:3-3-02 | Approved pharmacy technician training programs.
 

The purpose of this rule is to set standards for pharmacy technician training programs to ensure that graduates of the programs have the basic knowledge and experience in general pharmacy to practice in most pharmacy settings.

(A) The state board of pharmacy hereby approves the following pharmacy technician training programs:

(1) A pharmacy technician training program that holds a current accreditation from the American society of health-system pharmacists/accreditation council for pharmacy education.

(2) A program of training for pharmaceutical technicians conducted by a branch of the Armed Forces of the United States, the Indian health service of the United States department of health and human services, or the United States department of veterans affairs.

(3) An employer-based training program that meets the requirements in paragraph (B) of this rule.

(4) A pharmacy technician training program offered by an Ohio public high school as part of a career-technical education program approved by the Ohio department of education pursuant to section 3317.161 of the Revised Code. Each career-technical education program shall require approval by the state board of pharmacy in accordance with standards adopted by the board. Instructions for obtaining board approval will be made available on the board's website: www.pharmacy.ohio.gov.

(5) Successful completion of a doctor of pharmacy (PharmD) program from an approved school of pharmacy in accordance with rule 4729-5-01 of the Administrative Code if the applicant's graduation date is within five years of an application for registration.

(6) Held an active pharmacist or pharmacy intern license or registration in good standing from a licensing agency of any state or jurisdiction for at least one year within five years of an application for registration.

(B) An employer-based training program shall comply with all the following:

(1) The program shall have a program director. The program director and the employer licensed as a terminal distributor of dangerous drugs shall be accountable for the overall quality of the employer-based training program.

The program director shall be a licensed pharmacist in this or any other state that is in good standing.

(2) The program shall consist of didactic and practical experience training, as follows:

(a) A didactic training component that includes, at a minimum, instruction in all of the following:

(i) Mathematical calculations essential to the duties of a pharmacy technician;

(ii) Federal and state laws, rules, and regulations that affect pharmacy practice, including specific laws, rules, and regulations which address the use of technicians;

(iii) Medical and pharmaceutical terminology, symbols, and abbreviations used in the practice of pharmacy and components of a prescription;

(iv) Preparation, packaging, labeling, and proper storage of dangerous drugs;

(v) Knowledge and skills in areas of science relevant to the pharmacy technician's role, including pharmacology;

(vi) Medication safety and error prevention;

(vii) Maintaining confidentiality of patient information, including the Patient Rights and Health Insurance Portability and Accountability Act (HIPAA);

(viii) Ethical and professional standards of practice;

(ix) Recordkeeping and inventory control; and

(x) Patient and caregiver communication, including communicating with diverse populations.

(b) Didactic training may include self-directed learning experiences, including but not limited to home study, computer programs, internet or web-based courses, or any other coursework approved by the program director.

(c) The program shall ensure the required didactic training evaluates a participant's knowledge of the topics listed in paragraph (B)(2)(a) of this rule. The evaluation must include an examination consisting of a minimum of ninety questions in accordance with testing guidelines adopted by the board. The employer shall have procedures that ensure the security and integrity of the examination materials, describe the testing format, and define the successful completion of an examination, which must be at least seventy-five per cent. The examination shall consist primarily of multiple choice, essay, or short answer questions. The questions on the examination shall not be given to the examinee prior to taking the examination. The answers to the examination must not be given to the examinee prior to or during the examination. The examinee shall agree in writing not to share the questions or answers to the examination with any other person.

(d) The didactic training requirements in paragraph (B)(2)(a) of this rule are waived if the trainee has a current pharmacy technician certification from an organization that has been recognized by the board.

(e) Three hundred hours of practical experience in a pharmacy under the direct supervision of a licensed pharmacist that directly relates to the activities permitted in paragraph (B) of rule 4729:3-3-01 of the Administrative Code.

(3) A written or electronic record of training and education shall be maintained as part of the training program that documents the completion of the training requirements, including the number of practical experience hours completed.

(4) It shall be the responsibility of the terminal distributor of dangerous drugs providing employer-based training to ensure that the documentation provided to pharmacy technician trainees accurately reflects the completion of an approved training program. Failure on the part of the terminal distributor of dangerous drugs to ensure the accuracy of training documentation shall be considered a violation of rule 4729:5-4-01 of the Administrative Code.

(5) The program director must ensure that regular and ongoing assessments of program effectiveness are conducted and use the evaluations for continuous improvement of the program. Measures shall include, but are not limited to, the following:

(a) Program completion; and

(b) Program participant satisfaction.

(6) The program shall maintain the following records for a minimum of three years and shall be furnished to the state board of pharmacy within three business days of receipt of a request from the board:

(a) All technician training records and evaluations;

(b) Program assessments conducted in accordance with this rule.

(7) Employer-based training programs may be subject to audit to ensure compliance with the requirements of this rule.

(a) An employer-based training program subject to audit shall provide all requested documentation demonstrating compliance with this rule within thirty days of a request by the board.

(b) Unless an extension is granted, failure to provide the requested documentation within thirty days of a request by the board may result in the suspension of the approval status of the training program.

(c) After reviewing the training program, the board may return it to the employer for revision. Failure to make the necessary revisions may result in the suspension of the approval status of the training program.

(d) The approval status of a training program may be reinstated only after the employer meets the requirements of this rule and any additional requirements as determined by the board.

(C) In order to perform non-sterile drug compounding, a pharmacy technician trainee shall complete the following training requirements prior to compounding non-sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <795>, as defined in rule 4729:7-1-01 of the Administrative Code.

(2) If preparing non-sterile hazardous compounded drugs in accordance with rule 4729:7-2-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <800>, as defined in rule 4729:7-1-01 of the Administrative Code.

(3) If preparing non-sterile radiopharmaceuticals in accordance with rule 4729:5-6-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <825>, as defined in rule 4729:5-6-01 of the Administrative Code.

(4) Non-sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(5) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible person's designee will sign the documentation records to show that the employee was appropriately trained in accordance with this paragraph.

(6) Ensuring pharmacy technician trainees are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(7) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(8) The training required pursuant to this paragraph may be used to meet the practical experience hours required in paragraph (B)(2)(e) of this rule.

(D) In order to perform sterile drug compounding, a pharmacy technician trainee shall complete the following training requirements prior to compounding sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <797>, as defined in rule 4729:7-1-01 of the Administrative Code.

(2) If preparing sterile hazardous compounded drugs in accordance with rule 4729:7-2-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <800>, as defined in rule 4729:7-1-01 of the Administrative Code.

(3) If preparing sterile radiopharmaceuticals in accordance with rule 4729:5-6-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <825>, as defined in rule 4729:5-6-01 of the Administrative Code.

(4) Sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(5) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible person's designee will sign the documentation records to show that the employee was appropriately trained in accordance with this paragraph.

(6) Ensuring pharmacy technician trainees are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(7) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(8) The training required pursuant to this paragraph may be used to meet the practical experience hours required in paragraph (B)(2)(e) of this rule.

(E) A terminal distributor of dangerous drugs and the licensee's responsible person shall be responsible for the implementation of additional training that is of appropriate breadth and depth to clearly address the competencies for a technician trainee to safely and effectively work in a specific practice setting.

(F) Unless otherwise approved by the board, a board approved training program is only valid for application as a registered pharmacy technician or certified pharmacy technician in accordance with rule 4729:3-2-01 of the Administrative Code if the program was completed within five years of an application for registration.

(G) Paragraph (F) of this rule does not apply in the following circumstances:

(1) An applicant for registration has been actively practicing as a pharmacy technician in this or another state within one year of application to the board; or

(2) An applicant has maintained a current pharmacy technician certification from an organization that has been recognized by the board.

(H) An individual may sit for an examination to obtain a pharmacy technician certification from an organization that has been recognized by the board at any time.

Last updated March 7, 2024 at 7:44 AM

Supplemental Information

Authorized By: 4729.26, 4729.94
Amplifies: 4729.90, 4729.96, 4729.95, 4729.94, 4729.93, 4729.921, 4729.92, 4729.91, 4729.901
Five Year Review Date: 3/7/2029
Prior Effective Dates: 2/16/2018
Rule 4729:3-3-03 | Registered pharmacy technicians.
 

(A) A registered pharmacy technician shall wear a name tag or badge which contains the designation "Registered Pharmacy Technician." The required designation may be added to an existing name tag or badge. The name tag or badge and the required designation shall contain lettering of a legible size.

(B) A registered pharmacy technician may, under the direct supervision of a pharmacist, engage in the following activities at a location licensed as a terminal distributor of dangerous drugs to the extent that the activities do not require the exercise of professional judgment:

(1) Accepting new written, faxed or electronic prescription orders from a prescriber or a prescriber's agent but shall not include verbal orders;

(2) Requesting refill authorizations for dangerous drugs from a prescriber or prescriber's agent, so long as there is no change from the original prescription;

(3) Entering information into and retrieving information from a database or patient profile;

(4) Preparing and affixing labels;

(5) Stocking dangerous drugs and retrieving those drugs from inventory;

(6) Counting and pouring dangerous drugs into containers;

(7) Placing dangerous drugs into containers prior to dispensing by a pharmacist;

(8) Non-sterile drug compounding in accordance with the required training in paragraph (D) of this rule;

(9) Sterile drug compounding in accordance with the required training in paragraph (E) of this rule;

(10) Packaging and selling a dangerous drug to a patient or patient representative;

(11) Sending or receiving electronic prescriptions between pharmacies accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner;

(12) Stocking automated drug storage systems, floor stock, and crash carts at a location licensed as a terminal distributor of dangerous drugs if either of the following applies:

(a) The terminal distributor utilizes barcode administration for restocking the drugs and develops and implements a quality assurance program to ensure the accuracy of the personnel stocking the dangerous drugs; or

(b) For restocking automated drug storage systems only: a pharmacist verifies the final dispensing of a dangerous drug removed from the automated drug storage system.

(C) A registered pharmacy technician may:

(1) Engage in remote entry of prescriptions in accordance rule 4729:5-5-25 of the Administrative Code; or

(2) Engage in remote entry of medication orders in accordance with rule 4729:5-9-02.15 of the Administrative Code.

(D) In order to perform non-sterile drug compounding, a registered pharmacy technician shall complete the following training requirements prior to compounding non-sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <795>, as defined in rule 4729:7-1-01 of the Administrative Code.

(2) If preparing non-sterile hazardous compounded drugs in accordance with rule 4729:7-2-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <800>, as defined in rule 4729:7-1-01 of the Administrative Code.

(3) If preparing non-sterile radiopharmaceuticals in accordance with rule 4729:5-6-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <825>, as defined in rule 4729:5-6-01 of the Administrative Code.

(4) Non-sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(5) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible person's designee will sign the documentation records to show that the employee was appropriately trained in accordance with this rule.

(6) Ensuring registered pharmacy technicians are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(7) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(E) In order to perform sterile drug compounding, a registered pharmacy technician shall complete the following training requirements prior to compounding sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <797>, as defined in rule 4729:7-1-01 of the Administrative Code.

(2) If preparing sterile hazardous compounded drugs in accordance with rule 4729:7-2-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <800>, as defined in rule 4729:7-1-01 of the Administrative Code.

(3) If preparing sterile radiopharmaceuticals in accordance with rule 4729:5-6-03 of the Administrative Code, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter <825>, as defined in rule 4729:5-6-01 of the Administrative Code.

(4) Sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(5) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible persons designee will sign the documentation records to show that the employee was appropriately trained in accordance with this rule.

(6) Ensuring registered pharmacy technicians are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(7) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(F) A registered pharmacy technician shall be permitted to perform sterile compounding in accordance with this rule if all the following apply:

(1) The registered pharmacy technician is in the process of studying to obtain technician certification from an organization that has been recognized by the board;

(2) The registered pharmacy technician shall not engage in sterile drug compounding at the location licensed as a terminal distributor of dangerous drugs for longer than eighteen months from the date the technician completed the required sterile compounding training in paragraph (E) of this rule.

(3) A terminal distributor of dangerous drugs that permits a registered pharmacy technician to engage in sterile drug compounding shall develop and implement a process to ensure the registered pharmacy technician does not exceed the time limitation established in paragraph (F)(2) of this rule. The terminal distributor of dangerous drugs shall be accountable for a registered technician found to be in violation of this paragraph.

(G) A terminal distributor of dangerous drugs and the licensee's responsible person shall be responsible for the implementation of policies and procedures for additional training appropriate to duties and responsibilities performed by a registered pharmacy technician as well as an ongoing quality assurance plan to ensure competency.

Last updated March 7, 2024 at 7:45 AM

Supplemental Information

Authorized By: 4729.26, 4729.94
Amplifies: 4729.90, 4729.96, 4729.95, 4729.94, 4729.93, 4729.921, 4729.92, 4729.91, 4729.901
Five Year Review Date: 3/7/2029
Prior Effective Dates: 12/4/2017, 4/1/2022
Rule 4729:3-3-04 | Certified pharmacy technicians.
 

(A) As used in this rule, "positive identification" has the same meaning as in rule 4729:5-5-01 of the Administrative Code.

(B) A certified pharmacy technician shall wear a name tag or badge which contains the designation "Certified Pharmacy Technician." The required designation may be added to an existing name tag or badge. The name tag or badge and the required designation shall contain lettering of a legible size.

(C) A certified pharmacy technician may, under the direct supervision of a pharmacist, engage in the following activities at a location licensed as a terminal distributor of dangerous drugs to the extent that the activities do not require the exercise of professional judgment:

(1) Accepting new written, faxed or electronic prescription orders from a prescriber or a prescriber's agent. New verbal prescription orders from a prescriber or a prescriber's agent for non-controlled drugs may be accepted pursuant to paragraph (C)(13) of this rule.

(2) Entering information into and retrieving information from a database or patient profile.

(3) Preparing and affixing labels.

(4) Stocking dangerous drugs and retrieving those drugs from inventory.

(5) Counting and pouring dangerous drugs into containers.

(6) Placing dangerous drugs into containers prior to dispensing by a pharmacist.

(7) Non-sterile drug compounding in accordance with the required training in paragraph (D) of this rule.

(8) Sterile drug compounding in accordance with the required training in paragraph (E) of this rule.

(9) Packaging and selling a dangerous drug to a patient or patient representative.

(10) Sending or receiving electronic prescriptions between pharmacies accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner.

(11) Stocking automated drug storage systems, floor stock, and crash carts at a location licensed as a terminal distributor of dangerous drugs.

(a) Notwithstanding the definition of direct supervision in rule 4729:3-1-01 of the Administrative Code, a certified pharmacy technician may stock automated drug storage systems, crash carts, and floor stock at a location licensed as a terminal distributor of dangerous drugs if a pharmacist is not physically present at the licensed location and all of the following apply:

(i) A pharmacist is readily available to answer questions of the certified pharmacy technician;

(ii) A pharmacist is responsible for conducting routine verifications of the activities of the certified pharmacy technician to prevent the diversion of dangerous drugs;

(iii) A pharmacist is fully responsible for all activities conducted by the certified pharmacy technician at the licensed location.

(12) Requesting refill authorizations for dangerous drugs from a prescriber or prescriber's agent, so long as there is no change from the original prescription;

(13) Accepting new verbal prescription orders, including refill authorizations, for non-controlled drugs from a prescriber or a prescriber's agent pursuant to all of the following:

(a) The pharmacist on duty who is supervising the activity of the certified pharmacy technician will determine if the technician is competent to receive a verbal order.

(b) The pharmacist on duty who is supervising the activity of the certified pharmacy technician is responsible for the accuracy of a prescription order received by a technician.

(c) The pharmacist on duty must be immediately available to answer questions or discuss the prescription order received by a certified pharmacy technician.

(d) The certified pharmacy technician may not receive a prescription order for a controlled substance.

(e) If applicable, the certified pharmacy technician receiving a prescription order must document the full name of the prescriber's agent.

(f) The receiving certified pharmacy technician shall immediately reduce the prescription order to writing, which may include entering the information directly into a computerized record keeping system, and shall review the prescription with the pharmacist on duty.

(g) Prior to dispensing, positive identification of the receiving certified pharmacy technician and the pharmacist on duty shall be recorded to identify the responsibility for the receipt of the prescription.

(h) The certified pharmacy technician and the pharmacist on duty must meet all other applicable rules for the receipt of new verbal prescription orders pursuant to agency 4729 of the Administrative Code.

(14) Send or receive copies of non-controlled prescriptions pursuant to all of the following:

(a) The pharmacist on duty who is supervising the activity of the certified pharmacy technician will determine if the technician is competent to send or receive a prescription copy.

(b) The pharmacist on duty who is supervising the activity of the certified pharmacy technician is responsible for the accuracy of a prescription copy that is sent or received by a technician.

(c) The pharmacist on duty must be immediately available to answer questions or discuss the prescription copy that is sent or received by a certified pharmacy technician.

(d) The certified pharmacy technician may not send or receive a prescription copy for a controlled substance.

(e) The pharmacist or certified pharmacy technician receiving a prescription copy from a certified pharmacy technician must document the full names of the sending technician and the technician's supervising pharmacist. The receiving technician shall immediately reduce the prescription copy to writing, which may include entering the information directly into a computerized record keeping system, and shall review the prescription with the pharmacist on duty. Prior to dispensing, positive identification of the certified pharmacy technician and the pharmacist on duty shall be recorded to identify the responsibility for the receipt of the copy.

(f) The pharmacist or certified pharmacy technician sending a prescription copy to a certified technician must document the full names of the receiving technician and the technician's supervising pharmacist.

(g) The certified technician and the pharmacist on duty must meet all other applicable rules for the transfer of a prescription copy pursuant agency 4729 of the Administrative Code.

(15) Contacting a prescriber or prescriber's agent to obtain clarification for a prescription order if the clarification does not require the exercise of professional judgment.

(16) Performing diagnostic laboratory testing pursuant to agency 4729 of the Administrative Code.

(D) A certified pharmacy technician may:

(1) Engage in remote entry of prescriptions in accordance rule 4729:5-5-25 of the Administrative Code; or

(2) Engage in remote entry of medication orders in accordance with rule 4729:5-9-02.15 of the Administrative Code.

(E) In order to perform non-sterile drug compounding, a certified pharmacy technician shall complete the following training requirements prior to compounding non-sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <795>.

(2) Non-sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(3) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible person's designee will sign the documentation records to show that the employee was appropriately trained in accordance with this rule.

(4) Ensuring certified pharmacy technicians are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(5) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(F) In order to perform sterile drug compounding, a certified pharmacy technician shall complete the following training requirements prior to compounding sterile preparations:

(1) Training shall comply with the requirements set forth in the United States pharmacopeia chapter <797>.

(2) Sterile drug compounding training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and shall not be transferable to another practice site, except between practice sites under common ownership and control.

(3) When the responsible person or a pharmacist designated by the responsible person is satisfied with the employee's knowledge and proficiency, the responsible person or the responsible person's designee will sign the documentation records to show that the employee was appropriately trained in accordance with this rule.

(4) Ensuring certified pharmacy technicians are properly trained shall be the responsibility of the terminal distributor of dangerous drugs and the licensee's responsible person.

(5) All training requirements set forth in this paragraph shall be appropriately documented and made readily retrievable for immediate inspection by an agent of the state board of pharmacy. Documentation shall be maintained by the terminal distributor of dangerous drugs for a minimum of three years.

(G) A terminal distributor of dangerous drugs and the licensee's responsible person shall be responsible for the implementation of policies and procedures for additional training appropriate to duties and responsibilities performed by a certified pharmacy technician as well as an ongoing quality assurance plan to ensure competency.

Last updated April 1, 2022 at 8:30 AM

Supplemental Information

Authorized By: 4729.26, 4729.10, 4729.94
Amplifies: 4729.90, 4729.901, 4729.91, 4729.92, 4729.921, 4729.93, 4729.94, 4729.95, 4729.96
Five Year Review Date: 4/1/2027
Prior Effective Dates: 3/1/2019, 7/3/2020
Rule 4729:3-3-05 | Certified pharmacy technician administration of diagnostic tests.
 

(A) A certified pharmacy technician under the direct supervision of a pharmacist may administer clinical laboratory improvement amendments (CLIA) waived diagnostic laboratory testing provided the following conditions are met:

(1) The pharmacy or facility licensed as a terminal distributor of dangerous drugs is certified by the United States department of health and human services (HHS), as a clinical laboratory through the CLIA;

(2) The pharmacy or facility licensed as a terminal distributor of dangerous drugs has obtained a CLIA certificate of waiver from HHS; and

(3) The responsible person of the terminal distributor of dangerous drugs and the terminal distributor of dangerous drugs shall ensure and document that all certified pharmacy technicians conducting CLIA waived tests pursuant to this rule receive appropriate training to conduct testing in a safe and effective manner.

(B) This rule applies only to the administration and evaluation of laboratory testing by individuals licensed or registered in accordance with Chapter 4729. of the Revised Code.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.44, 4729.41
Five Year Review Date: 1/1/2025
Rule 4729:3-3-06 | Immunization administration.
 

(A) A certified or registered pharmacy technician who meets the requirements of paragraph (B) of this rule and is working under the direct supervision of a pharmacist who meets the requirements of rule 4729:1-3-02 of the Administrative Code, may do any of the following:

(1) In the case of an individual who is seven years of age or older but not more than thirteen years of age, administer to the individual an immunization for any of the following:

(a) Influenza;

(b) COVID-19; or

(c) Any other disease, but only pursuant to a prescription.

(2) In the case of an individual who is thirteen years of age or older, administer to the individual an immunization for any disease, including an immunization for influenza or COVID-19.

(3) The pharmacist on duty who is supervising the technician may prohibit, limit, or restrict the type of immunizations administered, including the age of the patient, by the technician.

(B) For a certified or registered pharmacy technician to be authorized to engage in the administration of immunizations, comply with all the following requirements:

(1) Complete a practical training program that meets the requirements set forth in paragraph (C) of this rule.

(2) Administer immunizations authorized by a physician-established protocol that meets the requirements of rule 4729:1-3-02 of the Administrative Code.

(3) Be authorized by the supervising pharmacist to administer immunizations. The supervising pharmacist may restrict the type of immunizations provided by a certified or registered technician.

(4) Receive and maintain certification to perform basic life-support procedures by successfully completing a basic life-support training course certified by the American red cross, American heart association or other training course approved by the board. Certification shall be obtained and maintained through courses that are conducted in- person or, at a minimum, offer an in-person or electronic hands-on training component.

(5) The pharmacist on duty who is supervising the technician shall be on-site to administer epinephrine or diphenhydramine, or both, to individuals in emergency situations resulting from adverse reactions to the immunizations administered by the registered or certified pharmacy technician.

(6) The pharmacist on duty who is supervising the technician determines if the technician is competent to administer immunizations.

(C) A course in the administration of immunizations developed pursuant paragraph (B) of this rule shall meet the following requirements:

(1) The instructor shall be a licensed health care professional and have the appropriate education and experience to teach a course in the administration of immunizations.

(2) The content must meet the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services.

(3) The course shall be conducted by an accreditation council for pharmacy education (ACPE) accredited provider.

(4) The course must be a minimum of six hours in length and include, at a minimum, the following topic areas:

(a) A review of immunology that includes a discussion of the body's immune system reaction to immunizations.

(b) A review of each immunization recommended by the committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services (8/5/2022):

(i) Disease states associated with the immunization;

(ii) Type or nature of activity of the immunization;

(iii) Administration schedules;

(iv) Routes of administration;

(v) Injection sites;

(vi) Dosages;

(vii) Monitoring and treatment of the patient for adverse reactions;

(viii) Patient populations;

(ix) Precautions and contraindications; and

(x) Proper storage requirements for the immunization.

(c) A review of sterile technique in injectable dosage preparation and administration.

(d) A minimum of one hour of instruction and physical participation in administration techniques.

(e) A review of the proper disposal procedures for contaminated needles and immunizations.

(f) A review of the proper procedures for accidental needle sticks.

(5) The course must provide a method to evaluate the successful comprehension of the content.

(6) The course must provide a method to demonstrate the participant has successfully completed the course.

(D) Courses on immunization administration may be reviewed by the state board of pharmacy. A training course that fails to comply with the requirements set forth in this rule shall be considered in violation of this rule.

(E) The pharmacy employing the technician shall ensure informed consent is obtained pursuant to rule 4729:5-5-04 of the Administrative Code prior to the administration of an immunization.

(F) The pharmacy employing the technician shall ensure the technician maintains the competency and skills necessary to safely administer immunizations. The pharmacy shall ensure the technician has initial and annual documented assessment of competency in immunization administration.

(G) Immunization records shall be maintained in accordance with rule 4729:5-5-04 of the Administrative Code.

(H) The pharmacy where a technician is administering immunizations in accordance with this rule shall comply with the vaccine information statement requirements of the National Vaccine Childhood Injury Act, 42 USC Section 300aa-26 (12/14/1993).

(I) For each immunization administered to an individual by a certified or registered pharmacy technician, other than an immunization for influenza administered to an individual eighteen years of age or older, the pharmacy employing the technician shall be responsible for ensuring the notification of the individual's primary care provider or, if the individual has no primary care provider, the board of health of the health district in which the individual resides or the authority having the duties of a board of health for that district under section 3709.05 of the Revised Code. The notice shall be given not later than thirty days after the immunization is administered. Notification shall be conducted using one of the following methods that is capable of confirming delivery of the required notification:

(1) Electronic mail;

(2) Interoperable electronic medical records system;

(3) Facsimile;

(4) Electronic prescribing system;

(5) Electronic pharmacy record system;

(6) Reporting to the state's immunization registry;

(7) Documented verbal communication; or

(8) Any other method of notification that might reasonably be expected to allow for the confirmed transmission of the required notification.

(J) The pharmacy employing a certified or registered technician authorized to provide immunizations in accordance with this rule, shall maintain, or have immediate access to, the following records on file at the location(s) where the pharmacy technician administers immunizations in accordance with this rule:

(1) Proof of successful completion of a training course specified in paragraph (C) of this rule;

(2) Proof of maintenance of certification to perform basic life-support procedures in accordance with paragraph (B)(4) of this rule; and

(3) Proof of competency assessments as required in paragraph (F) of this rule.

(K) A pharmacist practicing within an outpatient pharmacy shall not supervise more than three pharmacy personnel engaged in the administration of immunizations pursuant to this rule and rule 4729:2-3-03 of the Administrative Code.

(L) A pharmacist supervising an immunization clinic outside of an outpatient pharmacy shall not supervise more than six pharmacy personnel engaged in the administration of immunizations pursuant to this rule and rule 4729:2-3-03 of the Administrative Code.

Last updated September 1, 2023 at 8:59 AM

Supplemental Information

Authorized By: 4729.26,4729.94
Amplifies: 4729.91, 4729.93
Five Year Review Date: 9/1/2028