State requirements · California

California customer license requirements for distributors

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

By Workd, makers of WorkdID. Updated .

Short answer

A wholesaler may furnish dangerous drugs or devices only to an authorized person. Before selling to someone it does not know, it must contact the Board, or the other agency that licensed the buyer, to confirm the buyer is authorized. Deliveries go only to the premises on the buyer's permit. For shipments out of state, the seller must determine that the recipient is legally allowed to receive them. Records of furnishing dangerous drugs and devices must be kept for at least three years from the date they are made and be available to inspectors during business hours. WorkdID by Workd checks California 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 keep3 years
Separate device or DME distributor licenseYes

What California requires before you ship

A wholesaler may furnish dangerous drugs or devices only to an authorized person. Before selling to someone it does not know, it must contact the Board, or the other agency that licensed the buyer, to confirm the buyer is authorized. Deliveries go only to the premises on the buyer's permit. For shipments out of state, the seller must determine that the recipient is legally allowed to receive them.

Who counts as an authorized buyer: A person holding a Board permit that lets it buy dangerous drugs or devices within the scope of that permit, or another person legally authorized to receive them, such as licensed prescribers (physicians, dentists, podiatrists, optometrists, veterinarians and others listed in B&P 4059.5(d)), manufacturers, and Board licensees.

"shall contact the board or, if the person is licensed or registered by another government entity, that entity" Cal. Code Regs. tit. 16, § 1783(a)-(c); Cal. Bus. & Prof. Code § 4059.5(b), (e)

Records to keep

Records of furnishing dangerous drugs and devices must be kept for at least three years from the date they are made and be available to inspectors during business hours.

Source: Cal. Code Regs. tit. 16, § 1783(e)

Licenses a distributor needs in California

Prescription drug wholesale distributor

No one may act as a wholesaler or third-party logistics provider of dangerous (prescription) drugs or dangerous devices without a Board license. Nonresident wholesalers that ship into California are also covered.

Source: Cal. Bus. & Prof. Code §§ 4043, 4160

Medical device and DME distributors

A wholesaler is defined to include anyone who sells for resale any drug or device covered by section 4022 (dangerous drugs and devices, meaning prescription-only items). So wholesalers of prescription devices need a Board wholesaler license. California also licenses home medical device retailers through the Department of Public Health, which we did not review.

Source: Cal. Bus. & Prof. Code §§ 4043, 4160(a)

Controlled substances

We did not confirm a separate California controlled substance registration for wholesalers.

Where to look up a California license

Federal rules that apply in every state

How WorkdID handles California accounts

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

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Questions distributors ask

Does California require distributors to verify customer licenses?

A wholesaler may furnish dangerous drugs or devices only to an authorized person. Before selling to someone it does not know, it must contact the Board, or the other agency that licensed the buyer, to confirm the buyer is authorized. Deliveries go only to the premises on the buyer's permit. For shipments out of state, the seller must determine that the recipient is legally allowed to receive them. See Cal. Code Regs. tit. 16, § 1783(a)-(c); Cal. Bus. & Prof. Code § 4059.5(b), (e).

What records must a distributor keep in California?

Records of furnishing dangerous drugs and devices must be kept for at least three years from the date they are made and be available to inspectors during business hours. See Cal. Code Regs. tit. 16, § 1783(e).

Does California license medical device or DME distributors?

A wholesaler is defined to include anyone who sells for resale any drug or device covered by section 4022 (dangerous drugs and devices, meaning prescription-only items). So wholesalers of prescription devices need a Board wholesaler license. California also licenses home medical device retailers through the Department of Public Health, which we did not review. See Cal. Bus. & Prof. Code §§ 4043, 4160(a).

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

Pharmacy licenses are issued by the California State Board of Pharmacy and physician licenses by the Medical Board of California. 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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