| Customer verification | Federal rules apply |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | No separate license |
What Delaware requires before you ship
We did not find a Delaware rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. We found no Delaware rule that tells a wholesaler who it may sell to or that it must check a buyer's license. The Board rules require wholesalers to follow federal, state and local law, so federal DSCSA authorized trading partner rules still apply.
Source: 24 Del. C. §§ 2540-2546; 24 Del. Admin. Code 2500-8.0 (searched)
Records to keep
Wholesalers must keep records of the source, identity and quantity of drugs received and distributed, and the dates. Records must be available for inspection for 3 years after the drugs are disposed of. Records kept at a central location that are not electronic must be produced within 2 working days.
Source: 24 Del. Admin. Code 2500-8.5.2
Licenses a distributor needs in Delaware
Prescription drug wholesale distributor
No one may distribute drugs at wholesale to anyone other than the ultimate consumer without a Board license to operate a pharmaceutical establishment. Each location needs its own license. Wholesale applicants must name key personnel, submit floor plans and a lease or deed, prove home state licensure where it applies, and pass fingerprint background checks.
Source: 24 Del. C. § 2540(b); § 2540A(a), (d); 24 Del. Admin. Code 2500-8.0
Medical device and DME distributors
The Board licenses drug wholesalers, manufacturers, outsourcing facilities, third-party logistics providers and medical gas distributors. We found no Delaware license for distributors of prescription devices or DME in the pharmacy statute or Board rules.
Source: 24 Del. C. § 2540A
Controlled substances
Any distributor that handles controlled substances in Delaware must get a state controlled substance registration every two years, in addition to DEA registration. Board rules repeat that permittees distributing controlled substances must be registered with DEA and the state.
Source: 16 Del. C. § 4732(a); 24 Del. Admin. Code 2500-8.5.3
Where to look up a Delaware license
- Pharmacies and pharmacy permits: Delaware Board of Pharmacy (Division of Professional Regulation)
- Physicians and other practitioners: Delaware Board of Medical Licensure and Discipline
- 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 Delaware accounts
WorkdID by Workd checks every Delaware 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 Delaware file is ready when someone asks for it.
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