| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 6 years |
| Separate device or DME distributor license | In some cases |
What Florida requires before you ship
Florida lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. It is a prohibited act to sell or transfer a prescription drug to someone who is not authorized, under the law of the place where they receive it, to buy or possess it. Florida rules also limit wholesale distributors to authorized trading partners. For Schedule II and III controlled substances, distributors must have written policies to credential the physicians and pharmacies that buy from them and keep those records.
Who counts as an authorized buyer: A person authorized under the law of the jurisdiction where the drug is received to purchase or possess prescription drugs. Records must carry the purchaser's Florida permit number, and the license or permit number of any different delivery location.
"The sale or transfer of a prescription drug to a person that is not authorized under the law of the jurisdiction" Fla. Stat. § 499.005(15); Fla. Admin. Code R. 61N-1.030(6); Fla. Stat. § 499.0121(15)
Records to keep
Distribution records must show the seller and its Florida permit number, the ship-from address, the date, the drug name, strength, quantity and NDC, the purchaser's name and Florida permit number, unit prices, and the disposition. If the drugs are delivered somewhere other than the purchaser, the delivery location and its license number must be on the record too. Records must be created at the time of the transaction and kept at least 6 years after disposition.
Source: Fla. Stat. § 499.0121(6)(b), (f); Fla. Admin. Code R. 61N-1.012(2)
Licenses a distributor needs in Florida
Prescription drug wholesale distributor
A permit is required before operating as a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, a restricted prescription drug distributor, a third party logistics provider and several other types.
Source: Fla. Stat. § 499.01(1)
Medical device and DME distributors
Florida requires a device manufacturer permit for those who make, repackage or assemble medical devices, but has no permit for wholesale distributors of devices. A separate AHCA license is required for anyone who provides home medical equipment and services to consumers or accepts physician orders for it. Neither rule limits who a device wholesaler may sell to.
Source: Fla. Stat. § 499.01(2)(o); Fla. Stat. § 400.93
Controlled substances
We found no separate state controlled substance registration for distributors beyond the Chapter 499 permit and DEA registration. Wholesale distributors must report Schedule II to V receipts and distributions to the state every month, credential physician and pharmacy buyers of Schedule II and III drugs, and review orders over 7,500 unit doses of one controlled substance in a month.
Source: Fla. Stat. § 499.0121(14)-(15)
Where to look up a Florida license
- Pharmacies and pharmacy permits: Florida Board of Pharmacy
- Physicians and other practitioners: Florida Board of Medicine
- 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 Florida accounts
WorkdID by Workd checks every Florida 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 Florida file is ready when someone asks for it.
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