| Customer verification | Must verify the buyer's license |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | Yes |
What Texas requires before you ship
Before a manufacturer or wholesale distributor sells prescription drugs to a customer it does not already know, it must check that the customer is legally allowed to receive them. The customer must be authorized by DSHS, by the right state licensing board, or by federal law.
Who counts as an authorized buyer: A person legally authorized by DSHS or the appropriate state licensing authority to receive prescription drugs, or a person authorized by federal law to receive them.
"must verify the person is legally authorized by the department or the appropriate state licensing authority to receive the prescription drugs" 25 Tex. Admin. Code § 229.429(f)(2)
Records to keep
Pedigree statements must be kept by both the purchaser and the wholesale distributor for at least three years. Records must be ready for inspection by DSHS or a Texas peace officer by the second business day after a request.
Source: 25 Tex. Admin. Code § 229.429(f)(3)(F)
Licenses a distributor needs in Texas
Prescription drug wholesale distributor
Wholesale distributors of prescription drugs need a DSHS license for each place of business. Out-of-state distributors that ship prescription drugs into Texas also need a Texas license. In Texas this license comes from DSHS, not the Board of Pharmacy.
Source: 25 Tex. Admin. Code § 229.424
Medical device and DME distributors
Texas requires a DSHS license to distribute or manufacture medical devices in the state, one license per place of business. Exemptions include intracompany sales only and distributing only from a place of business outside Texas. The rule makes prescription device distributors keep a record of every prescription device received and where it went. We did not find a rule limiting who a device distributor may sell to, and the rule sets no retention period for these records.
Source: 25 Tex. Admin. Code §§ 229.434, 229.435, 229.441(k)
Controlled substances
Texas law now requires DEA registration (or a DEA exemption) to manufacture or distribute controlled substances. The separate Texas DPS registration was phased out in 2016.
Source: Tex. Health & Safety Code § 481.061(a)
Where to look up a Texas license
- Pharmacies and pharmacy permits: Texas State Board of Pharmacy
- Physicians and other practitioners: Texas Medical Board
- 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 Texas accounts
WorkdID by Workd checks every Texas 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 Texas file is ready when someone asks for it.
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