e-News June 2026

Reminder: OARRS ASAP 5.0 Format Mandatory for OARRS Reporting July 1, 2026

This is a reminder that all Ohio dispensers must begin submitting electronic dispensation data to OARRS in the ASAP 5.0 format starting July 1, 2026. Requirements are outlined in Ohio Administrative Codes 4729:8-3-02 and 4729:8-3-03. A “dispenser” includes pharmacies and any prescriber who personally furnishes reportable medications.

Warning Activation

OARRS has activated warnings for any submission not compliant with ASAP 5.0. These warnings apply to all submissions (ASAP 4.2b and ASAP 5.0).

Please note: Warnings will not cause data submissions to be rejected. A grace period will be in place before warnings convert to errors.

Support and Resources

If you need assistance with data submissions, please contact Bamboo’s Clearinghouse at 844‑464‑4767.

The Data Submission Guide for Dispensers is available here.
The guide for Medical Marijuana Dispensers is available here.

Dispensers who have made reasonable efforts but cannot meet the July 1 deadline may request a 6‑month extension from the Board’s Executive Director. The extension request form is available here.

Thank you for your attention to this important transition.

EMS Rules for Stakeholder Comment - Comments Due 7/29/2026

On February 5, 2026, the Drug Enforcement Administration (DEA) officially published its final rule implementing the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEMA). To ensure harmonization between state and federal requirements for the handling of controlled substances and other dangerous drugs by EMS organizations, the Board is proposing amendments to Chapter 4729:5-15 of the Administrative Code.

A copy of the proposed rules can be accessed here: www.pharmacy.ohio.gov/EMSupdate.

Comments on the proposed rules will be accepted until the close of business on Wednesday, July 29, 2026. Please send all comments to the following email address: rulecomments@pharmacy.ohio.gov

EMS Drug Administration Documentation Guidance Added

The Board recently added a new FAQ to the EMS Inspection Guide (www.pharmacy.ohio.gov/EMSinspect) to address how to document drug administration conducted by personnel not employed by an EMS organization (e.g., mutual aid scenario) or who otherwise do not have access to the EMS organization’s record keeping system. For more information, please see FAQ #30 (page 59) of the EMS Inspection Guide.

Reminder: Electronic Positive Identification Requirements Effective January 15, 2027

Effective 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; and
Ancillary services as defined in rule 4729:5-5-02.1 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.

NOTE: 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.

Reminder: Licensure Requirements for Investigational New Drug Products

The Board would like to remind licensees that effective February 4, 2026, Ohio licensure as a terminal distributor of dangerous drugs (TDDD) from the Ohio Board of Pharmacy is required for all entities engaged in phase 2 or 3 clinical trials of an investigational new drug or product.

For more information on these licensure requirements, the Board developed this guidance document: www.pharmacy.ohio.gov/IND.

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:

Pharmacy Compounding in Ohio (www.pharmacy.ohio.gov/pharmcompound)
Non-Resident Pharmacy Compounding in Ohio (www.pharmacy.ohio.gov/NRPcompound)

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.

Regarding Fentanyl and Xylazine Test Strip Distribution Through the Ohio Board of Pharmacy

The Board regrets to inform licensees that funding for fentanyl and xylazine test strip distribution through the Ohio Board of Pharmacy has expired and the Board has ceased the distribution of test strips.

Licensees are still able to request naloxone overdose and recognition brochures while supplies last. Use the following link to order: www.pharmacy.ohio.gov/nalbrochure.

DSCSA's Foundational Blueprint for 2023 Interoperability

The Board would like to remind pharmacies about DSCSA's Foundational Blueprint for 2023 Interoperability resource. This blueprint provides a crucial framework for implementing the DSCSA's 2023 interoperability requirements and establishing business and compliance requirements believed necessary for efficient interoperability in line with the DSCSA's intentions.

You can visit the blueprint at: https://dscsagovernance.org/blueprint/.

Resource from NABP: Inside the Fight Against Falsified Medications - How Traceability Protects Patients

Keeping the prescription drug supply chain secure is essential for ensuring patient safety. However, the immense scale and complexity of the global supply chain have made it a persistent target for criminal organizations. The fight against falsified medications demands constant innovation and adaptation. As counterfeit methods evolve, so must the strategies used to detect and prevent them, requiring increasing collaboration across the supply chain to protect patients.

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.

Bluesky

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Ohio Board of Pharmacy

Mike DeWine, Governor | Steven W. Schierholt, Executive Director