| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | In some cases |
What Indiana requires before you ship
Indiana lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. Indiana makes it illegal to sell or transfer a legend drug to anyone who is not allowed, under the law of the place where they receive it, to buy or receive legend drugs from the seller. The law does not spell out a verification step. In practice, a distributor has to check each customer's license to stay within this rule. Indiana's express verification duties apply to suppliers, not customers. For example, a licensed distributor must collect license details before buying from an unlicensed but accredited distributor.
Who counts as an authorized buyer: A person authorized under the law of the jurisdiction where it receives the drug to purchase or receive legend drugs, such as a licensed pharmacy, practitioner, hospital, or licensed distributor.
"The sale or transfer of a legend drug to a person that is not authorized under the law of the jurisdiction ..." Ind. Code § 25-26-14-21.5(a)(7)
Records to keep
Licensed distributors must keep a record system covering their receipts and shipments of legend drugs. Records must be kept for at least 3 years after the drug leaves their hands and be available to state and federal inspectors. Records of authentications under the pedigree rules are also kept for 3 years.
Source: Ind. Code § 25-26-14-17(3)
Licenses a distributor needs in Indiana
Prescription drug wholesale distributor
No one may engage in wholesale distribution of legend (prescription) drugs in Indiana without a Board of Pharmacy license. The law also requires accreditation from NABP's Verified-Accredited Wholesale Distributors program or another board-approved accreditor, plus the fee. Each facility needs its own license. Out-of-state distributors may be licensed by reciprocity.
Source: Ind. Code § 25-26-14-14
Medical device and DME distributors
Indiana's wholesale license covers legend drugs. We found no separate license for wholesale distributors of medical devices. Indiana does license home medical equipment providers. Home medical equipment means prescribed equipment that sustains, restores, or replaces a vital body function and needs individual adjustment or regular maintenance. Walkers, ambulatory aids, and commodes are excluded. That license covers serving patients. It does not set rules on which business customers a device wholesaler may sell to.
Source: Ind. Code ch. 25-26-21 (home medical equipment providers); § 25-26-21-2 (definition)
Controlled substances
Every person who makes or distributes controlled substances in Indiana must hold a state controlled substance registration, renewed every two years. This is in addition to DEA registration.
Source: Ind. Code § 35-48-3-3
Where to look up a Indiana license
- Pharmacies and pharmacy permits: Indiana Board of Pharmacy (Indiana Professional Licensing Agency)
- Physicians and other practitioners: Medical Licensing Board of Indiana (Indiana Professional Licensing Agency)
- NPI: NPPES NPI Registry
- DEA registrations: DEA Diversion Control Division
Federal rules that apply in every state
- A prescription device "is to be sold only to or on the prescription or other order of such practitioner," or to a business lawfully distributing it (21 CFR 801.109).
- A prescription drug wholesale distributor's trading partners "may be only authorized trading partners," which for a pharmacy means one licensed under state law (21 U.S.C. 360eee-1(c)(3)).
How WorkdID handles Indiana accounts
WorkdID by Workd checks every Indiana 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 Indiana file is ready when someone asks for it.
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