State requirements · Ohio

Ohio customer license requirements for distributors

What a distributor of prescription drugs, medical devices, or medical supplies has to confirm about a Ohio customer before shipping, and what it has to keep on file.

By Workd, makers of WorkdID. Updated .

Short answer

Before selling dangerous drugs to anyone in Ohio, a distributor must run a documented check of the Board's online roster. The check confirms the buyer holds a terminal distributor or distributor license. For limited licenses, also check the buyer's approved drug list. Buyers who claim an exemption, such as prescribers, must sign a written attestation every year. For prescribers, also verify their license to prescribe. Keep records of every receipt, sale, and disposal of dangerous drugs. WorkdID by Workd checks Ohio pharmacy and medical licenses, NPI records, and DEA registrations for every account, every day, and keeps a dated record of each check.

Customer verificationMust verify the buyer's license
Records to keep5 years
Separate device or DME distributor licenseIn some cases

What Ohio requires before you ship

Before selling dangerous drugs to anyone in Ohio, a distributor must run a documented check of the Board's online roster. The check confirms the buyer holds a terminal distributor or distributor license. For limited licenses, also check the buyer's approved drug list. Buyers who claim an exemption, such as prescribers, must sign a written attestation every year. For prescribers, also verify their license to prescribe.

Who counts as an authorized buyer: Licensed terminal distributors of dangerous drugs, limited to the drug categories on their license. Licensed manufacturers, outsourcing facilities, 3PLs, repackagers, and wholesalers. Out-of-state distributors licensed in their home state and not selling within Ohio. Persons exempt under ORC 4729.541, such as certain prescribers. Pain clinics need a pain management clinic license.

"the distributor shall conduct a documented query of a roster maintained by the board to determine if the purchaser is licensed" Ohio Admin. Code 4729:6-3-04; Ohio Rev. Code §§ 4729.51(B)-(D), 4729.60

Records to keep

Keep records of every receipt, sale, and disposal of dangerous drugs. Records must show the seller, the drug name, NDC, and quantity, the dates, and the buyer's name and ship-to address. You must also keep records and procedures that prevent sales to unauthorized persons. Keep them for five years after disposition. Exemption attestations are also kept for five years. Wholesale sales must be reported to the state drug database.

Source: Ohio Admin. Code 4729:6-5-02; 4729:6-3-04(D)

Licenses a distributor needs in Ohio

Prescription drug wholesale distributor

Only a licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor of dangerous drugs may sell dangerous drugs at wholesale in Ohio, with narrow exceptions for occasional pharmacy sales. "Dangerous drugs" are prescription drugs, plus injectables and some other products.

Source: Ohio Rev. Code §§ 4729.51(A), 4729.52

Medical device and DME distributors

Home medical equipment services providers need a Board of Pharmacy license. A manufacturer or wholesale distributor of home medical equipment that does not sell to the public is exempt. We found no separate Ohio license for wholesale sales of prescription devices to businesses.

Source: Ohio Rev. Code §§ 4752.01, 4752.02

Controlled substances

Ohio does not use a separate controlled substance registration for distributors. Controlled substances are handled under a category III distributor license, which requires controlled substance inventories. Distributors must also run suspicious order monitoring with due diligence on new customers before the first sale and every year after.

Source: Ohio Admin. Code 4729:6-3-05, 4729:6-3-06

Where to look up a Ohio license

Federal rules that apply in every state

How WorkdID handles Ohio accounts

WorkdID by Workd checks every Ohio customer you sell to against the state's pharmacy and medical boards, the NPI registry, and the DEA, every day. It flags an expiration or a board action within a day of posting, and in Workd order entry it can hold the order until your compliance team clears the account. Every check is saved with the date and the board record, so your Ohio file is ready when someone asks for it.

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Questions distributors ask

Does Ohio require distributors to verify customer licenses?

Before selling dangerous drugs to anyone in Ohio, a distributor must run a documented check of the Board's online roster. The check confirms the buyer holds a terminal distributor or distributor license. For limited licenses, also check the buyer's approved drug list. Buyers who claim an exemption, such as prescribers, must sign a written attestation every year. For prescribers, also verify their license to prescribe. See Ohio Admin. Code 4729:6-3-04; Ohio Rev. Code §§ 4729.51(B)-(D), 4729.60.

What records must a distributor keep in Ohio?

Keep records of every receipt, sale, and disposal of dangerous drugs. Records must show the seller, the drug name, NDC, and quantity, the dates, and the buyer's name and ship-to address. You must also keep records and procedures that prevent sales to unauthorized persons. Keep them for five years after disposition. Exemption attestations are also kept for five years. Wholesale sales must be reported to the state drug database. See Ohio Admin. Code 4729:6-5-02; 4729:6-3-04(D).

Does Ohio license medical device or DME distributors?

Home medical equipment services providers need a Board of Pharmacy license. A manufacturer or wholesale distributor of home medical equipment that does not sell to the public is exempt. We found no separate Ohio license for wholesale sales of prescription devices to businesses. See Ohio Rev. Code §§ 4752.01, 4752.02.

Where do I look up a Ohio pharmacy or practitioner license?

Pharmacy licenses are issued by the State of Ohio Board of Pharmacy and physician licenses by the State Medical Board of Ohio. Both publish a public lookup. WorkdID checks them for you every day.

See WorkdID check your own customer list.

WorkdID by Workd checks every customer license you sell to, every day, and can hold an order before it ships to an account that is out of good standing.

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Related

This page explains general rules and is not legal advice. Rules change. Confirm current requirements with the state board or your counsel before relying on them.

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