Resources

The below rule changes were effective on March 4, 2024. If you have questions about these rule changes, please contact BMD Member Daphne Kackloudis.

Criteria for Licensure by Examination - OAC 4729:1-2-01

Under the rule, the minimum passing score on both the NAPLEX and MPJE exams are determined by the national association of boards of pharmacy (NABP). Previously, the minimum passing score was a 75. The amended rule also requires candidates to submit electronic or ink fingerprint impressions for a criminal records check prior to receiving approval to take the required examinations. The candidate must submit fingerprint impressions within sixty days of the date the board receives the application materials. After sixty days, a candidate must submit a new application, the required fee, and fingerprint impressions, as the original application will be considered “abandoned.”

Criteria for Licensure by Reciprocity - OAC 4729:1-2-02

The amended rule removes the requirement that candidates applying for licensure by reciprocity personally appear before the full board within six months of the date that the application is filed with the Board. The amended rule also requires candidates who qualify for licensure by reciprocity to successfully complete a course developed by the Board that includes a scored evaluation component on Ohio’s law and rules governing the practice of pharmacy. Candidates who do not successfully complete this course within six months following the submission of a completed application must file a new application for reciprocity. A candidate’s fee for reciprocity is $337.50.

Examination Application for Licensure as a Pharmacist - OAC 4729:1-2-03

Every person applying to take the examination for licensure as a pharmacist must submit certain application materials to the state Board of Pharmacy. Under the rule, applicants are no longer required to submit a head and shoulders passport photograph (2x10 inches) taken within the previous six months. However, the amended rule adds language requiring applicants to submit “any other information or documentation as determined by the board.” The amended rule also added language that the state Board of Pharmacy may make an applicant eligible to take the required examinations as soon as the Board receives all the items required of applicants and the results of a criminal records check.

Pharmacist Change of Name, Address, or Employment - OAC 4729:1-2-06

Ohio law requires a pharmacist who has a legal change of name to notify the Board of Pharmacy within thirty (30) days of such change. Under the rule, notification of a name change can be accompanied by a government-issued identification card which reflects the pharmacist’s name change or any other documentation as approved by the Board. Further, the amended rule requires that requests for a duplicate wall certificate be issued in the new name of the pharmacist. Then, the pharmacist must promptly destroy the wall certificate that no longer reflects their legal name. However, the Board may only issue a duplicate wall certificate to a pharmacist who has lost, misplaced, or damaged their original wall certificate. A pharmacist seeking a duplicate wall certificate is required to pay a $22.50 fee.

Pharmacist Licensure and Renewal - OAC 4729:1-2-07

Under the rule, an initial pharmacist license issued by the state Board of Pharmacy on or after the first of May of every odd-numbered year entitles the individual to whom it is issued to practice as a pharmacist until the renewal date immediately following the next required renewal date. A pharmacist license must be renewed on the fifteenth day of September of every odd-numbered year and the renewal fee is $250.

Continuing Education Requirements for Pharmacists - OAC 4729:1-5-02

The amended rule adds new language requiring pharmacists to complete three continuing education units (CEUs) (thirty contact hours) of approved continuing education prior to the renewal of the pharmacist's license. At least 0.2 CEUs of the total required CEUs must be obtained in pharmacy jurisprudence and at least 0.2 CEUs of the total required CEUs must be obtained in patient or medication safety. Previously, the Board required that pharmacists complete four CEUs (forty contact hours) of approved continuing education. Further, a pharmacist who obtains an initial license by reciprocity or examination must complete two CEUs (twenty contact hours) of approved continuing education to be completed prior to the renewal of the pharmacist's license.

Under the rule, a pharmacist who obtains initial licensure by reciprocity or examination shall not have to complete the continuing education requirements for the initial licensure period prior to the renewal of that pharmacist’s license. Previously, pharmacists who obtained initial licensure by reciprocity or examination had to complete at least 0.1 CEU in pharmacy jurisprudence and 0.1 CEU in patient or medication safety. Further, a pharmacist whose license has lapsed or is being renewed after Board action must obtain three CEUs of continuing education during the two-year period immediately preceding the date their renewal application is filed with the board. At least 0.2 CEUs must be in pharmacy jurisprudence and 0.2 CEUs must be in patient or medication safety.

The below rule changes were effective on March 7, 2024. If you have questions about these rule changes, please contact BMD Member Daphne Kackloudis.

Registered Pharmacy Technicians - OAC 4729:3-3-03

Under the rule, a registered pharmacy technician may, under the direct supervision of a pharmacist, engage in sterile drug compounding at a location licensed as a terminal distributor of dangerous drugs (TDDD) (to the extent that the activity does not require the exercise of professional judgment).

The amended rule adds new training requirements for technicians preparing sterile and non-sterile compounded drugs. If preparing non-sterile hazardous compounded drugs, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter 800, and if preparing non-sterile radiopharmaceuticals, the training shall also comply with the applicable requirements set forth in United States pharmacopeia chapter 825.

Further, to perform sterile drug compounding, a registered pharmacy technician must complete the following training requirements prior to compounding sterile preparations that complies with the requirements set forth in the United States pharmacopeia chapter 797. If preparing sterile hazardous compounded drugs, the training must also comply with the applicable requirements set forth in United States pharmacopeia chapter 800, and if preparing sterile radiopharmaceuticals, the training must also comply with the applicable requirements set forth in United States pharmacopeia chapter 825.

Additionally, sterile drug compounding training must be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program and is not transferable to another practice site, unless the practice sites are under common ownership and control. 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 must sign the documentation records to show that the employee was appropriately trained.

The amended rule added language that a registered pharmacy technician can perform sterile compounding if the registered pharmacy technician is in the process of studying to obtain technician certification from an organization that has been recognized by the Board. However, the technician must not engage in sterile drug compounding at the location licensed as a TDDD for longer than eighteen months from the date the technician completed their required sterile compounding training.

Terminal Distributor of Dangerous Drugs Licensing and Renewal - OAC 4729:5-2-02

Under this new rule, all TDDD licenses expire on the thirty-first day of March of every odd-numbered year and must be renewed biennially. An initial TDDD license issued on or after the thirtieth day of January of every odd-numbered year will expire on the thirty-first day of March of the next odd-numbered year.

A TDDD who has experienced a change in responsible person and has not yet reported such change to the Board, must submit the required notification prior to submitting a renewal application. However, a TDDD who has experienced a change in description and has not yet reported such change to the Board, must submit the required application and fee in lieu of a renewal application. Lastly, TDDD licensure is not applicable to any facility owned or operated by the following: (1) the United States Department of Defense; (2) the United States Department of Veterans Affairs; or (3) any other federal agency.

Labeling of Drugs Dispensed on Prescriptions - OAC 4729:5-5-06

The amended rule adds the requirement that no drug may be dispensed by outpatient prescription unless a label is affixed to the container and the label includes the contact phone number of the dispensing pharmacy.

Distributor of Dangerous Drugs Licensing and Renewal - OAC 4729:6-2-02

Under the new rule, all drug distributor licenses expire on the thirtieth day of June of every odd-numbered year and should be renewed biennially. A drug distributor who has experienced a change in responsible person and has not yet reported such change to the Board, must submit the required notification prior to submitting a renewal application. Further, a drug distributor who has experienced a change in description and has not yet reported such change to the Board, shall submit the required application and fee in lieu of a renewal application.

Licensure as a distributor of dangerous drugs is not applicable to any facility owned or operated by the following: (1) the United States Department of Defense; (2) the United States Department of Veterans Affairs; or (3) any other federal agency. Lastly, a distributor of dangerous drugs is prohibited from engaging in any authorized activity of a drug distributor until a valid license is issued by the Board.

Drugs Compounded in a Pharmacy - OAC 4729:7-2-03

The amended rule removes language that a registered pharmacy technician under the personal supervision of a pharmacist may only engage in non-sterile drug compounding.

The below rules are scheduled for a public hearing on April 23, 2024. Public comments are due by this date. Please contact BMD Member Daphne Kackloudis for help drafting comments or with questions you may have.

Disposal of Controlled Substances - OAC 4729:5-3-01

Under the rule, a record of drug destruction shall be made in accordance with the September 2023 version of 21 C.F.R. 1304 and must be maintained for a minimum of three (3) years from the date of destruction and made readily retrievable to the Board of Pharmacy upon request.

Employment of Individuals with Felony Convictions - OAC 4729:5-3-10

Pursuant to the June 2023 version of 21 C.F.R. 1301.76, a TDDD that is a Drug Enforcement Agency registrant must not employ any person who (1) has been convicted of a felony relating to controlled substances, or who (2) has had an application for drug enforcement administration registration denied, revoked, or surrendered for cause, in any position which allows access to controlled substances.

Persons Eligible to Transfer Sample Drugs to a Charitable Pharmacy - OAC 4729:5-7-03

This amended rule provides the requirements for the distribution of sample drugs by a charitable pharmacy. An eligible sample drug must only be transferred directly to a charitable pharmacy by (1) a manufacturer licensed in accordance with section 4729.52 of the Revised Code, (2) a person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer, or (3) a prescriber practicing at a location that is licensed as a TDDD. However, nothing in this rule prohibits the donation of a sample drug to a charitable pharmacy operating as a drug repository. Instead, this amended rule now permits charitable pharmacy to accept donations as part of a drug repository program. 

Criminal Records Checks - OAC 4729:6-2-03 

The amended rule specifies who must submit to a criminal records check when applying for a drug distributor license. A new distributor of dangerous drug license will not be issued until (1) the responsible person on the application for licensure and (2) other relevant persons based upon the drug distributor's business type, submit fingerprints to the Ohio Bureau of Criminal Investigation.

Further, under the amended rule, all members of a limited liability company must submit to fingerprinting. If the limited liability company has a member which is not a natural person, then the limited liability company’s president, vice president, secretary, treasurer, and chief executive officer, or any equivalent position must be fingerprinted.

Additionally, under the rule, the executive director or any equivalent position of a nonprofit organization must submit to fingerprinting in addition to the responsible person.

Drug Distributor Applications - OAC 4729:6-2-04

The amended rule specifies the specific information that must be included on a drug distributor license application.

Under the rule, the type of ownership or operation (i.e., sole proprietorship, partnership, limited liability company, corporation, or government agency, or nonprofit organization) must be included on the form that the person applying for a licensure as a distributor of dangerous drugs submits to the Board.

Further, the following information for the owner(s) and/or operator(s) of the drug distributor must be provided to the Board on their application:

• For a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor.
• For a limited lability company: the full name, business address, social security number, and date of birth of each member. If the member(s) is not a natural person, each business entity that is a member having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.
• For a nonprofit organization: the full name, business address, social security number, and date of birth of the executive director or any equivalent position.

Additionally, the amended rule adds that the Board must not license an entity located outside of the United States.

Procedure for Discontinuing Business as a Distributor of Dangerous Drugs - OAC 4729:6-2-06

Under the rule, a distributor of dangerous drugs who plans to discontinue business activities must file a notice with the Board. The notice must be submitted in a manner determined by the Board within thirty (30) days of discontinuation of business as a distributor of dangerous drugs. Previously, the notice had to be submitted at least thirty (30) days in advance of the proposed date of discontinuing business, unless waived by the board for extraordinary circumstances beyond the licensee's control.

Additionally, under the amended rule, distributors are required to complete inventory of all controlled substances being transferred, or disposed on the date they discontinue business. The inventory should list the name, strength, dosage form, and quantity of all controlled substances transferred or disposed. Further, a copy of the inventory must be included in the records of each licensee involved in the transfer.

Verification of Licensure Prior to Sale or Purchase - OAC 4729:6-3-04

Under the amended rule, distributors of dangerous drugs are required to verify licensure prior to the sale or purchase of dangerous drugs or make an attestation if the entity is exempt from licensing requirements. All verification must be done electronically, and records related to verification must be maintained for five years. Previously, the records had to be maintained for three years. Specifically, drug distributors must ensure that all attestations are maintained for five years after the sale or distribution of the dangerous drug. Previously, they had to maintain attestations for three years.

Controlled Substances Inventory Requirements - OAC 4729:6-3-06

The amended rule requires distributors to maintain all inventory records for a period of five years from the completion date of the inventory and made readily retrievable. Previously, they had to maintain inventory records for three years.

Sales of Dangerous Drugs On-line - OAC 4729:6-3-07

Under the amended rule, all persons selling or offering to sell dangerous drugs via the internet into, out of, or within Ohio must be appropriately licensed by the state Board of Pharmacy. Previously, only those persons selling dangerous drugs via retail outlets had to be licensed.

Distributor of Dangerous Drugs Samples and Complimentary Supplies - OAC 4729:6-3-08

This amended rule provides procedures for the sale/distribution of complementary supplies and drug samples. Now, no drug distributor or distributor's representative (including sales representatives) may sell or distribute a sample of a drug to a licensed prescriber unless requested by the prescriber and the entity: (1) is licensed as a distributor of dangerous drugs or is exempted from licensure in accordance with 4729.541 of the Revised Code; and (2) maintains a record of such distribution for five years from the date of sale or distribution. Such records should be made readily retrievable.

Wholesale Distributors - General Operations - OAC 4729:6-5-01

This amended rule requires wholesalers to maintain records of dangerous drug destructions for five years. Further, records of dangerous drug destructions, other than controlled substances, must  contain the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date destroyed, the method of destruction, the positive identification of the responsible person that performed the destruction, and the positive identification of the person that witnessed the destruction.

Additionally, the appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs must be utilized to regularly document proper storage of dangerous drugs. Under the rule, temperature and humidity documentation must be made readily retrievable and maintained for five years from the last documented temperature and humidity reading. Previously, the records had to be maintained for three years.

Further, wholesale drug distributors must adopt a procedure to ensure that any adulterated dangerous drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure should provide for written documentation of the disposition of adulterated dangerous drugs and the documentation should be maintained for five years after disposition of the adulterated drugs. Previously, the documentation had to be maintained for three years.

Virtual Wholesalers - General Operations - OAC 4729:6-6-01

Under the amended rule, virtual wholesalers must maintain a procedure to ensure that any adulterated dangerous drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure should provide for written documentation of the disposition of adulterated dangerous drugs, which must be maintained for five years after disposition of the adulterated drugs. Previously, the documentation had to be maintained for three years. 

Brokers - General Operations - OAC 4729:6-7-01

Under the amended rule, an entity engaged in the brokering of dangerous drugs for the sole purpose of reverse distribution (e.g., disposal) is not required to obtain a license as a wholesale distributor of dangerous drugs with a broker classification.

Manufacturers - General Operations - OAC 4729:6-8-01

Under the amended rule, a manufacturer of dangerous drugs must maintain records of dangerous drug destructions, other than controlled substances, for five years. The destruction records must contain the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date destroyed, the method of destruction, the positive identification of the responsible person that performed the destruction, and the positive identification of the person that witnessed the destruction.

Additionally, manufacturers must have a procedure to ensure that any adulterated dangerous drugs are segregated from other drugs and destroyed. This procedure shall provide for written documentation of the disposition of adulterated dangerous drugs, and the documentation must be maintained for five years after disposition of the adulterated drugs. Previously, the documentation had to be maintained for three years. 

Dispensary Reporting into the Prescription Monitoring Program - OAC 4729:8-5-01

The amended rule lists the information that is required to be sent to the Board after the dispensing of medical marijuana (replacing OAC 3796:6-3-10).

Under the amended rule, a licensed dispensary must transmit the information set forth below within five minutes of the dispensing of any and all medical marijuana: (1) State license number, which shall be populated by a number provided by the Department of Commerce; (2) Dispensary name; (3) Dispensary address; (4) Dispensary telephone number; (5) Patient full name; (6) Patient registry identification number; (7) Patient residential address; (8) Patient telephone number; (9) Patient date of birth; (10) Patient gender; (11) Recommending physician's full name (first name and last name); (12) Drug enforcement administration physician identification number; (13) Date recommendation was issued by the recommending physician; (14) Indication whether the recommendation is new or a refill; (15) Number of the refill being dispensed; (16) Date order filled, which shall be the date medical marijuana is dispensed; (17) Order number, which shall be the serial number assigned to each medical marijuana product dispensed to a patient; (18) Quantity; (19) Days’ supply; (20) Product identifier, which shall be assigned by the Department of Commerce; (21) Date order written, which shall be the date the written recommendation was issued; (22) Payment code for either cash or third-party provider; and (23) Drug name, which shall be the brand name of the medical marijuana.

The dispensary should submit the above information electronically to the Board in the manner the Board requests, and a manner that ensures the confidentiality of the information in compliance with all federal and state laws, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com with any questions.