| Customer verification | Must verify the buyer's license |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | Yes |
What Maryland requires before you ship
A wholesale distributor may supply prescription drugs only to a person who is authorized by law to dispense or receive them. Deliveries must go to the address on the customer's license or permit. Pickup at the distributor's site is allowed only if the person's identity and authorization are properly established, and only to meet a patient's immediate need. Accounts must be in the name of the license or permit holder. Payment or credit may come only from the owner of record, CEO or CFO listed on that license. Distributors must also have written due diligence procedures for deals with parties not licensed by the Maryland Board. These include checking the party's other license, its identity and its recent inspections.
Who counts as an authorized buyer: A person authorized by law to dispense or receive prescription drugs, such as a pharmacy, a practitioner allowed to dispense or administer, or another permitted wholesale distributor. Delivery must go to the premises on the recipient's license or permit.
"A wholesale distributor may supply prescription drugs only to a person authorized by law to dispense or receive prescription drugs." Md. Code Ann., Health Occ. § 12-6C-09(b) to (d); COMAR 10.34.22.08
Records to keep
Distributors must keep inventories and records of every receipt and distribution of prescription drugs or devices. Records must show the source, the identity and quantity of items, and the dates. For drugs that left the normal distribution channel, they must also keep pedigrees. Records must be available for 3 years from when they were created. Records kept off site that cannot be pulled up electronically must be produced within 5 working days. Paperwork on destroying packaging is kept at least 3 years. Records of what happened to outdated product are kept 2 years.
Source: COMAR 10.34.22.07A
Licenses a distributor needs in Maryland
Prescription drug wholesale distributor
A wholesale distributor must hold a Board permit before it distributes prescription drugs or prescription devices into or within Maryland. This includes manufacturers that distribute, exclusive distributors and third-party logistics providers. The permit renews every 2 years and cannot be transferred. A buyer in Maryland may only buy prescription drugs or devices from a permit holder, a licensed pharmacist or an authorized prescriber.
Source: Md. Code Ann., Health Occ. §§ 12-6C-03, 12-6C-06; COMAR 10.34.22
Medical device and DME distributors
Maryland's wholesale distributor permit covers prescription devices as well as drugs. 'Wholesale distribution' means distributing prescription drugs or prescription devices to anyone other than a consumer or patient. A prescription device is any device that federal law says may be dispensed only by prescription. The statute's 'supply only to authorized persons' rule names prescription drugs only. But the purchase rule in § 12-6C-03(f) and the record rules cover devices too.
Source: COMAR 10.34.22.01, 10.34.22.02B(17), (22), (23); Md. Code Ann., Health Occ. § 12-6C-03(f)
Controlled substances
A wholesale distributor that handles controlled substances must register with the state as well as with the DEA.
Source: COMAR 10.34.22.07D(3)
Where to look up a Maryland license
- Pharmacies and pharmacy permits: Maryland Board of Pharmacy
- Physicians and other practitioners: Maryland Board of Physicians
- 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 Maryland accounts
WorkdID by Workd checks every Maryland 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 Maryland file is ready when someone asks for it.
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