| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | Yes |
What Pennsylvania requires before you ship
Pennsylvania lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. Distributors may not sell nonproprietary (prescription) drugs or controlled substances to anyone the state drug act does not authorize to receive them. No express check step is written for prescription drugs. For controlled substances there is an express step: before shipping to someone not known to be registered, the distributor must make a good faith inquiry with the DEA.
Who counts as an authorized buyer: Persons authorized under the Controlled Substance, Drug, Device and Cosmetic Act to receive the product, such as licensed pharmacies, practitioners, and registered distributors.
"Distributing establishments shall not distribute nonproprietary drugs or controlled substances to persons unauthorized by the act to receive them." 28 Pa. Code § 25.33(a); 28 Pa. Code § 25.62(a)
Records to keep
Licensed wholesalers must keep inventories and records of all prescription drug receipts and distributions, showing the source, the drug and quantity, and the dates. Records must be available for two years after disposition. The Department of Health rules also require records of every purchase and sale of drugs and devices, including the name and address of each buyer, kept for 2 years.
Source: Act 1992-145, § 6(g); 28 Pa. Code § 25.33(c)
Licenses a distributor needs in Pennsylvania
Prescription drug wholesale distributor
A person may not run a facility in Pennsylvania that does wholesale distribution of prescription drugs without a license from the Department of Health. Each facility needs its own license. The Act's licensing duty is written for facilities located in Pennsylvania. Distributors must also hold a Department of Health registration under the Controlled Substance, Drug, Device and Cosmetic Act.
Medical device and DME distributors
Anyone who distributes drugs or devices in Pennsylvania must hold an annual Department of Health registration unless exempt. For distributors this covers devices labeled to require a physician's order. Out-of-state distributors without a Pennsylvania site must either register or keep a current list of their Pennsylvania representatives on file.
Source: 28 Pa. Code § 25.113
Controlled substances
Distributors of controlled substances must register with the Department of Health under the state drug act, and licensees that handle controlled substances must also register with DEA. Before shipping controlled substances to someone not known to be registered, the distributor must make a good faith inquiry with DEA.
Source: 28 Pa. Code § 25.113(e); 28 Pa. Code § 25.62; Act 1992-145, § 6(k)
Where to look up a Pennsylvania license
- Pharmacies and pharmacy permits: Pennsylvania State Board of Pharmacy (Department of State)
- Physicians and other practitioners: Pennsylvania State Board of Medicine (Department of State)
- 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 Pennsylvania accounts
WorkdID by Workd checks every Pennsylvania 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 Pennsylvania file is ready when someone asks for it.
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