State requirements · Missouri

Missouri customer license requirements for distributors

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

By Workd, makers of WorkdID. Updated .

Short answer

We did not find a Missouri rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. Missouri's distributor rules focus on where a distributor buys from, not who it sells to. A Missouri distributor may not knowingly buy from an unlicensed distributor or pharmacy, and pharmacies may not knowingly buy from unlicensed sources. We found no Missouri rule that expressly requires a distributor to check a customer's license before selling. Federal DSCSA trading-partner rules still apply. Distributors must keep records of every receipt and distribution of prescription drugs, showing the source, the drug and quantity, and the dates. WorkdID by Workd checks Missouri pharmacy and medical licenses, NPI records, and DEA registrations for every account, every day, and keeps a dated record of each check.

Customer verificationFederal rules apply
Records to keep3 years
Separate device or DME distributor licenseIn some cases

What Missouri requires before you ship

We did not find a Missouri rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. Missouri's distributor rules focus on where a distributor buys from, not who it sells to. A Missouri distributor may not knowingly buy from an unlicensed distributor or pharmacy, and pharmacies may not knowingly buy from unlicensed sources. We found no Missouri rule that expressly requires a distributor to check a customer's license before selling. Federal DSCSA trading-partner rules still apply.

Source: 20 CSR 2220-5.020(1); RSMo 338.315

Records to keep

Distributors must keep records of every receipt and distribution of prescription drugs, showing the source, the drug and quantity, and the dates. Records must be available for inspection for three years after the drugs are disposed of. Records kept off-site that are not electronically retrievable must be produced within two working days.

Source: 20 CSR 2220-5.030(3)(I)-(K)

Licenses a distributor needs in Missouri

Prescription drug wholesale distributor

Anyone who acts as a wholesale drug distributor, pharmacy distributor, drug outsourcer or third-party logistics provider in Missouri needs a license from the Board of Pharmacy first. This includes out-of-state distributors that ship into Missouri. A Missouri distributor may not knowingly buy legend drugs or drug-related devices from a distributor or pharmacy the board has not licensed or registered.

Source: RSMo 338.330, 338.333; 20 CSR 2220-5.020

Medical device and DME distributors

Missouri's wholesale drug distributor definition covers the transfer of a drug or a drug-related device. The board's rule defines a drug-related device as a device that meets the federal device definition and the federal restricted-device rule (21 U.S.C. 321(h) and 360j(e)), so prescription (restricted) devices fall inside the drug distributor license. We found no separate Missouri license for medical device or DME distributors, and no rule limiting who device distributors may sell to.

Source: RSMo 338.330; 20 CSR 2220-5.030(9)

Controlled substances

Anyone who manufactures, distributes or dispenses controlled substances in Missouri must first get a registration from the Department of Health and Senior Services, in addition to DEA registration.

Source: RSMo 195.030.2

Where to look up a Missouri license

Federal rules that apply in every state

How WorkdID handles Missouri accounts

WorkdID by Workd checks every Missouri 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 Missouri file is ready when someone asks for it.

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Questions distributors ask

Does Missouri require distributors to verify customer licenses?

We did not find a Missouri rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. Missouri's distributor rules focus on where a distributor buys from, not who it sells to. A Missouri distributor may not knowingly buy from an unlicensed distributor or pharmacy, and pharmacies may not knowingly buy from unlicensed sources. We found no Missouri rule that expressly requires a distributor to check a customer's license before selling. Federal DSCSA trading-partner rules still apply. See 20 CSR 2220-5.020(1); RSMo 338.315.

What records must a distributor keep in Missouri?

Distributors must keep records of every receipt and distribution of prescription drugs, showing the source, the drug and quantity, and the dates. Records must be available for inspection for three years after the drugs are disposed of. Records kept off-site that are not electronically retrievable must be produced within two working days. See 20 CSR 2220-5.030(3)(I)-(K).

Does Missouri license medical device or DME distributors?

Missouri's wholesale drug distributor definition covers the transfer of a drug or a drug-related device. The board's rule defines a drug-related device as a device that meets the federal device definition and the federal restricted-device rule (21 U.S.C. 321(h) and 360j(e)), so prescription (restricted) devices fall inside the drug distributor license. We found no separate Missouri license for medical device or DME distributors, and no rule limiting who device distributors may sell to. See RSMo 338.330; 20 CSR 2220-5.030(9).

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

Pharmacy licenses are issued by the Missouri Board of Pharmacy and physician licenses by the Missouri State Board of Registration for the Healing Arts. 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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