Regulatory

Regulatory

Regulatory

Are you buying PRP kits (medical devices) from an Unlicensed Dealer?

By unlicensed we don’t mean someone operating without a distribution agreement with a manufacturer, we mean someone breaking state laws by selling medical devices as an unlicensed “wholesaler”.

Companies, like us that sell or “distribute” medical devices to end users who dispense (pharmacies, physicians, etc.) are called wholesalers and must hold WDD (Wholesale Distributors of Drugs or Devices) licenses in New Jersey, New York and Pennsylvania among many other states.

Just because you recognize the manufacturer brand name, like EmCyte, doesn’t mean you’re purchasing from someone legally selling it to you. Exactly like there are unlicensed pharmacies selling brand name pharmaceuticals, there are unlicensed wholesalers selling brand name medical devices. Luckily states make verification public and easily accessible. New York, New Jersey and Pennsylvania’s links are below.

State Laws

NJ Law: N.J.A.C 8:21-3A (Registration of Wholesale Distributors of Drugs)

Distributors of prescription drugs, including medical gases, over-the-counter drugs and medical devices are subject to and responsible for meeting the same requirements of N.J.A.C. 8:21-3A Registration of Wholesale Distributors of Drugs.

Our NJ License: 5005403

NY Law: Article 137 §6808

No person, firm, corporation or association shall possess drugs, prescriptions or poisons for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing, or shall offer drugs, prescriptions or poisons for sale at retail or wholesale unless registered by the department as a pharmacy, wholesaler, manufacturer or outsourcing facility.

"Wholesaler" means a person who bottles, packs or purchases drugs, devices or cosmetics for the purpose of selling or reselling to pharmacies or to other channels as provided in this article.

Our NY License: 039332

PA Law: (P.L. 233, No. 64), known as The Controlled Substance, Drug, Device and Cosmetic Act

Any manufacturer, distributor and/or retailer of medical devices within the Commonwealth physically handling actual FDA approved medical devices or equipment must register

Our PA License: 7200001186

PRP Kits are Medical Devices

PRP Med Device Label

PRP kits are 510(k) cleared medical devices.

License Verification

Wholesale Distributor Licenses are all publicly searchable via state DOH and Pharmacy Board websites. Furthermore, vendors are required to hold the physical license – you can just ask your vendor for it.

5005403 (5-Line Medical Supply In State Wholesaler)

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039332 (5-Line Medical Supply Out of State Wholesaler)

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7200001186 (5-Line Medical Supply Distributor, Manufacturer, Retailer of Drugs (All Types) and/or Devices; Out of State Business)

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Don’t let an irresponsible vendor jeopardize your medical practice! Verify online, or ask for their license.

If you can’t find theirs or they won’t provide you one and you’d like to work with a licensed wholesaler please contact us.