NEW EFFECTIVE DATE: Electronic Positive Identification Requirements Effective March 31, 2027 | |
Now effective March 31, 2027 (previously January 15, 2027), amendments to OAC 4729:5-5-04 will require, with limited exceptions, that all Ohio outpatient pharmacies adopt electronic positive identification as part of the pharmacy’s record keeping system. This means that once effective, the rule will not permit the use of hardcopy records and manual signatures to capture positive identification except for the following:
- Compounding and the dispensation of compounded drugs;
- Ancillary services as defined in rule 4729:5-5-02.1 of the Administrative Code; and
- Records maintained in accordance with rule 4729:5-3-17 of the Administrative Code.
IMPORTANT: This change does not impact institutional pharmacies (except those that operate outpatient pharmacies), non-resident pharmacies, and other terminal distributors (EMS, clinics, OTPs, etc.). To review the upcoming amendments to the rule, visit: www.pharmacy.ohio.gov/positiveIDchange.
Waiver Request Process
A waiver of the requirement for electronic positive identification may be granted by the Board upon written request of an outpatient pharmacy. All requests must be submitted in writing using this form: www.pharmacy.ohio.gov/waiver.
IMPORTANT REMINDERS:
- The Board reserves the right to request additional information and documentation to render a decision as to whether to grant a waiver. Waivers will be granted on a limited basis and requests that do not include all the required information will not be reviewed by Board staff.
- Pharmacies who cannot meet the narrow qualifications for a waiver will be considered in violation of OAC 4729:5-5-04 if electronic positive identification is not adopted by March 31, 2027.
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Waivers requesting extensions to this requirement will not be granted at this time. Waivers are intended to alleviate economic hardship and/or to address pharmacies engaged in low volume dispensing. They are not intended to address delays in planning by licensees (NOTE: These requirements were initially announced in June 2025 thereby giving licensees more than 21 months to ensure compliance).
| Important Information for Terminal Distributors of Dangerous Drugs: New Responsible Person Requirements for Licensure Effective February 1, 2027 | | |
Effective February 1, 2027, OAC 4729:5-2-01 will require a responsible person (RP) for a terminal distributor of dangerous drugs (TDDD) to meet specific hourly on-site requirements or conduct regular site visits to ensure compliance with all applicable state and federal laws, regulations, and rules governing the distribution of dangerous drugs.
Licensees are strongly encouraged to utilize the current implementation window to ensure they can comply with the new requirements effective February 1, 2027. For the current requirements, please review the version of the rule in effect until February 1, 2027.
The Board of Pharmacy has created a guidance document outlining the new requirements for each TDDD license type, which can be accessed at www.pharmacy.ohio.gov/RPGuide.
What is a Responsible Person (RP)?
Every license issued to a terminal distributor or drug distributor (hospital, pharmacy, wholesaler, clinic, manufacturer, EMS, lab, etc.) by the Ohio Board of Pharmacy requires there to be a responsible person (RP). The RP ensures the licensee is compliant with all applicable state and federal laws, regulations, and rules governing the distribution of dangerous drugs. This includes supervision and control of dangerous drugs, security and control of dangerous drugs, and maintaining all drug records otherwise required. Home Medical Equipment Service Providers have similar requirements for designated representatives.
A terminal distributor or drug distributor must have an RP at all times. When there is a change of RP, the Board must be notified within ten days of the effective date of the appointment of the new RP. This requires the submission of a Change of Responsible Person Request in eLicense Ohio and the payment of a $15.00 processing fee.
Additional Guidance and Questions
For more information regarding these requirements, please review the Board’s guidance document at www.pharmacy.ohio.gov/RPGuide.
If you need additional information, the most expedient way to have your questions answered will be to e-mail the Board office by visiting: http://www.pharmacy.ohio.gov/contact.aspx.
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Certified Technician Renewal Information and Resources | The renewal period for Certified Pharmacy Technicians opens on Saturday, August 1, 2026. Important information and guidance about the upcoming renewal was emailed to licensees and can also be found at: www.pharmacy.ohio.gov/certifiedtechrenew. | Reminder: Change in Business Description Requirements for a Terminal Distributor of Dangerous Drugs | |
The Board of Pharmacy would like to remind Terminal Distributor of Dangerous Drugs (TDDD) licensees that any change in ownership, business or trade name, category, or address of a TDDD requires an application and required fee, which must be submitted within thirty days of any change in the ownership, business or trade name, category, or address.
The Board developed a guidance document that walks licensees through changing these items in eLicense. This document can be accessed here: www.pharmacy.ohio.gov/BusinessDescription.
| | Reminder for Compounding Pharmacies: Board of Pharmacy Adopts New USP 797 & USP 795 Standards - Enforcement Begins February 28, 2027 | | |
Effective February 28, 2026, revisions to OAC 4729:7-1-01 went into effect. These revisions require compliance with the newest versions of United States Pharmacopeia (USP) 797 & USP 795 (both adopted by USP on March 1, 2023). While the rule is effective on February 28, 2026, the Board has extended the enforcement date of the rule until February 28, 2027.
To assist both Ohio and non-resident pharmacies in complying with these new standards, the Board updated its compounding guidance documents:
For questions regarding pharmacy compounding standards, please review these documents. If you need additional information, the most expedient way to have your questions answered will be to e-mail the Board office by visiting: www.pharmacy.ohio.gov/contact.
| | FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | | |
FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness, and quality before they are marketed.
For more information and to read the FDA's recommendations for health care professionals and patients, visit: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
| | Article: Diverted HIV Medicines are Being Sold on Online Pharmacy-to-Pharmacy Platforms | | |
The Partnership for Safe Medicines and ADAP Advocacy are issuing a warning today that discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces qualify as suspicious products under U.S. Food and Drug Administration guidelines and the Drug Supply Chain Security Act.
Any HIV medicines available for sale on these platforms or any medicine you have bought and not yet dispensed should be considered a suspect product; any HIV products bought through these channels in your possession should be quarantined and verified before dispensing.
For more information, including an FAQ for pharmacists on these medicines, visit: https://www.safemedicines.org/2026/06/diverted-hiv-meds-on-p2p-platforms.html
| | Be Vigilant - Watch Out for Scammers! | | BOARD STAFF DO NOT ASK FOR MONEY OVER THE PHONE OR VIA EMAIL TO RESOLVE PENDING INVESTIGATIONS. WHEN IN DOUBT, PLEASE CONTACT THE BOARD IF YOU BELIEVE YOU ARE THE TARGET OF A SCAM. | | |
The Ohio Board of Pharmacy continues to learn that licensees are being targeted by scammers who claim to work for various governmental agencies (Board of Pharmacy, DEA, FBI, Department of Justice, etc.) to obtain money from the target. The Board strongly encourages licensees to be alert to avoid scammers.
Scammers may try to initiate contact via phone calls, emails, faxes, and letters purporting to originate from various state and federal agencies that include allegations of drug trafficking and threats of suspension against the target’s license.
Board of Pharmacy investigators will not ask for fine payment or personal/sensitive information over the phone and will never contact licensees via fax. As a reminder, administrative fines issued by the Board are not paid via gift cards or cryptocurrency. If the Board of Pharmacy is conducting an investigation and that individual faces action against their license, they will receive an official notice of opportunity for a hearing either via certified mail, personal service, or electronic registered mail.
If you are contacted by a scammer, please report this information using the Board’s online complaint form: www.pharmacy.ohio.gov/complaint. Additionally, reports should be made to your local law enforcement agency.
If you receive any suspicious calls or correspondence purporting to be from the Board of Pharmacy, we encourage you to call (614-466-4143) or email (contact@pharmacy.ohio.gov) the Board to confirm its legitimacy.
| | People call, text, and chat the 988 Lifeline to talk about a lot of emotional needs—not just thoughts of suicide. Whatever your reason, the #988Lifeline is there to help. There is hope. | | |
Ohio Board of Pharmacy
Mike DeWine, Governor | Steven W. Schierholt, Executive Director
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