| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 5 years |
| Separate device or DME distributor license | In some cases |
What New York requires before you ship
New York lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. Registered manufacturers, outsourcing facilities, and wholesalers may sell drugs and devices only to purchasers the law allows. The rule does not spell out how to check. In practice you must confirm each buyer is a registered or licensed party.
Who counts as an authorized buyer: The rule says "purchasers authorized by law." Under Educ. Law § 6808(1), that means registered pharmacies, wholesalers, manufacturers, and outsourcing facilities, plus practitioners allowed to possess drugs. For controlled substances, Public Health Law § 3320 lists licensed distributors and manufacturers, practitioners, pharmacists, pharmacies, institutional dispensers, outsourcing facilities, and authorized labs.
"Manufacturers, outsourcing facilities or wholesalers shall sell drugs and/or devices only to those purchasers authorized by law." 8 NYCRR § 63.6(c)(6)
Records to keep
Keep records of the receipt and disposition of all drugs and devices for five years. The department may review and copy them on request. Controlled substance distributors must also record the date, the name, address, and registration number of each customer, and the kind and quantity sold.
Source: 8 NYCRR § 63.6(c)(6); N.Y. Pub. Health Law § 3322
Licenses a distributor needs in New York
Prescription drug wholesale distributor
No one may hold or offer drugs for wholesale unless the department has registered them as a wholesaler, manufacturer, pharmacy, or outsourcing facility. Out-of-state wholesalers that ship into New York must also register.
Source: N.Y. Educ. Law § 6808(1) and (4); N.Y. Educ. Law § 6808-b
Medical device and DME distributors
New York's wholesaler rules cover "drugs and/or devices". The nonresident registration law refers to wholesalers "of drugs and/or devices." The core statute in § 6808(1) names only drugs, prescriptions, and poisons. Confirm with the Board whether your device line needs a wholesaler registration.
Source: 8 NYCRR § 63.6(c)(6); N.Y. Educ. Law § 6808-b
Controlled substances
Distributors of controlled substances need a state license under Public Health Law Article 33. They may distribute only to the classes of persons listed in § 3320.
Source: N.Y. Pub. Health Law §§ 3310, 3320, 3322
Where to look up a New York license
- Pharmacies and pharmacy permits: New York State Board of Pharmacy (NYSED Office of the Professions)
- Physicians and other practitioners: New York State Board for Medicine (NYSED Office of the Professions)
- 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 New York accounts
WorkdID by Workd checks every New York 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 New York file is ready when someone asks for it.
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