Medical Device & Drug Wholesaler 3PL

Requirements last verified: 2026-08-11

This guide explains Medical device & drug wholesaler / 3PL licensing requirements, including when a company must hold a wholesale drug distributor (WDD) or third‑party logistics provider (3PL) license, how federal DSCSA rules interact with state boards of pharmacy, and what device distributors must do at FDA and in selected states.

Medical device & drug wholesaler / 3PL: what’s the difference?

Drug Wholesale Distributor (WDD): takes title to prescription drug product and/or directs its sale or disposition. WDDs are DSCSA “trading partners,” must exchange product tracing data at each change of ownership, and are licensed by states. See DSCSA definitions and tracing duties in 21 U.S.C. 360eee and 360eee‑1. Statute • Statute • FDA FAQ.

Third‑Party Logistics Provider (3PL): provides warehousing or logistics services for prescription drugs without taking title or directing sale or disposition. 3PLs are DSCSA trading partners for possession, must be licensed (by states or under federal standards when finalized) and must only engage with authorized trading partners, but they do not exchange TI/TS because they do not transfer ownership. See DSCSA 3PL definition and FDA guidance clarifying roles. 21 U.S.C. 360eee • FDA guidance (PDF version here).

Medical device distributor: FDA requires establishment registration and device listing for manufacturers and initial importers; domestic distributors generally do not register unless they also manufacture, relabel, or repack. Many states separately license device distributors. See FDA device registration pages. FDA overview • Who must register • Overview of device regulation.

Licensing triggers: activities that require WDD vs 3PL

• Triggers WDD licensure: taking title to a prescription drug; brokering or directing sale/disposition of a drug; repackaging/relabeling counts as “manufacturing” under FD&C Act and may add manufacturer/repackager registration. 21 U.S.C. 360eee • 21 U.S.C. 360.
• Triggers 3PL licensure: receiving, storing, or shipping prescription drugs for others without taking title or directing sale (warehousing, fulfillment, transport coordination). 21 U.S.C. 360eee • FDA guidance.
• Does not trigger device FDA establishment registration: domestic device distributors that only store/ship finished devices and do not manufacture, relabel, repack, or import. Initial importers and manufacturers must register and list. FDA—Who must register • FDA overview.

Federal vs state: who regulates what?

• FDA (federal): sets DSCSA tracing/verification requirements, defines trading partners, operates the annual WDD/3PL reporting database, and will finalize national WDD/3PL licensure standards. FDA WDD/3PL database • Proposed national standards • Annual reporting.
• States: issue WDD and often 3PL licenses, set facility/personnel requirements, bonds, and fees. Examples below (CA, MD, FL). State licensure links via FDA.
• Devices: FDA handles establishment registration/listing for manufacturers and initial importers; some states require separate medical device distributor licenses (e.g., Texas). Texas DSHS • FDA device registration.

DSCSA pedigree/tracing/verification and where 3PLs fit

• Tracing (3T): WDDs must exchange Transaction Information and Transaction Statements with trading partners at each change of ownership; dispensers must receive and maintain it. FDA identifies standards for interoperable exchange; for enhanced security FDA recommends GS1 EPCIS. FDA tracing FAQ • DSCSA data exchange standards.
• Enhanced package‑level security: Interoperable, electronic tracing at the package level became enforceable after the 1‑year stabilization period ended on November 27, 2024, with certain targeted exemptions (e.g., small dispensers until November 27, 2026). FDA stabilization policy • Waivers/exemptions beyond stabilization • Targeted exemptions (Oct. 9, 2024).
• 3PL obligations: must be licensed and “authorized,” accept/transfer only with authorized partners, maintain handling/record systems, and support verification/recall requests; they typically do not generate TI/TS because they do not transfer ownership. FDA trading‑partner guidance.

Selected state requirements (quick scan)

State	Drug WDD license	3PL license	Device distributor	Bond/Surety	Fees (examples)	Renewal	Processing time
California	Wholesaler (resident/nonresident) via CA Board of Pharmacy	Third‑Party Logistics Provider (resident/nonresident); Designated Representative‑3PL Responsible Manager required	N/A at state level for most distributors; device makers/importers follow FDA	WDD: $100,000 surety (BPC §4162); 3PL: $90,000 (or $25,000 if ≤$10M prior‑year receipts) (BPC §4162.5)	Nonresident WDD app $1,000; Nonresident 3PL app $1,000; DR‑3PL app $345 (max) per BPC §4400 and fee schedule	Every 2 years (per license cycle); self‑assessment required by 16 CCR §1784	Board notes ~4–6 weeks for certain facility changes; initial timelines vary
Maryland	Wholesale Distributor Permit (prescription drug/device)	No MD 3PL permit currently required per Board FAQ; must follow DSCSA	Covered under wholesale distributor/device provisions	Surety bond or equivalent required with application (COMAR 10.34.22.03)	Initial application fee commonly $1,750–$3,250 (Board form)	2‑year term; expires May 31 (Health Occupations §12‑6C‑06)	Board form indicates 2–4 weeks after receipt of a complete app
Florida	Prescription Drug Wholesale Distributor (in‑state or out‑of‑state)	Third Party Logistics Provider permit (DBPR DDC)	Device distribution under Ch. 499 where applicable	Bond/security may be required under §499.012	Annual fees set by statute: WDD $300–$800; 3PL $200–$300	Annual	Varies by DBPR review; application on DBPR forms
Texas (devices)	Drug WDD via TX DSHS/Board structures (not covered here)	3PL depends on drug activities; TX follows DSCSA for drugs	Medical Device Distributor license from DSHS required for device distribution	See DSHS rules/fee schedule	Fees published by DSHS; distributor licensing available online	Annual/biennial per license type	Varies by DSHS processing

Sources: CA WDD • CA 3PL • CA fee schedule • CA WDD bond • CA 3PL bond • MD COMAR 10.34.22 • MD Board FAQ (3PL) • MD app/fees • MD renewal statute • FL fees §499.041 • FL bond §499.012 • FL 3PL app • TX DSHS devices.

Exact license names, forms, fees, bonds (state examples)

California (drug)

• Licenses: Wholesaler; Nonresident Wholesaler; Third‑Party Logistics Provider; Nonresident 3PL. WDD • 3PL.
• Responsible person: Designated Representative‑in‑Charge (WDD) or Designated Representative‑3PL Responsible Manager (3PL). BPC definitions.
• Bonds: WDD $100,000 (BPC §4162); 3PL $90,000 (or $25,000 if ≤$10M prior‑year receipts) (BPC §4162.5). Board forms: WDD bond • 3PL bond • statute fees in BPC §4400 and fee schedule.
• Self‑assessment: required for WDDs and 3PLs (Form 17M‑26) per 16 CCR §1784. Regulation.

Maryland (drug/device)

• Wholesale Distributor Permit (includes drugs/devices as defined). Minimum application elements and surety bond or equivalent required by COMAR 10.34.22.03. COMAR .03.
• 3PL: Board states that 3PLs are not permitted in Maryland (i.e., no separate 3PL permit) and follow DSCSA; see Board FAQ. Board FAQ.
• Fees: Board application lists $1,750 or $3,250 depending on category; confirm on the current form. Application.
• Renewal: every two years; permits expire May 31. §12‑6C‑06.

Florida (drug)

• Permits: Prescription Drug Wholesale Distributor; Out‑of‑State Prescription Drug Wholesale Distributor; Third Party Logistics Provider. §499.01 • 3PL rule.
• Fees: WDD $300–$800; 3PL $200–$300 annually (set by §499.041). §499.041.
• Bond/Security: permitted entities may be required to file surety bond or equivalent security per §499.012. §499.012.
• Forms: DBPR‑DDC‑220 (3PL) application. Form.

Texas (medical devices)

• Medical Device Distributor License required from DSHS to distribute devices; online or paper application available; see DSHS licensing page and fee schedules. DSHS.

VAWD/DDA accreditation

Many states and trading partners look for NABP Drug Distributor Accreditation (DDA), formerly VAWD. Accreditation is not a federal license but can streamline state reviews and partner due diligence. NABP reference (VAWD naming).

How to register with FDA and verify authorization

Drugs (WDD/3PL)

1. Obtain required state license(s) in each state where you engage in distribution/logistics. Use FDA’s state‑site index to locate the correct board and verify license status. FDA index.
2. Submit annual FDA report as a WDD or 3PL (facility/contacts/state licensure) and confirm your listing appears in FDA’s public database. FDA annual reporting.
3. Implement DSCSA systems for tracing, verification, and partner authorization; use the FDA‑identified standards for interoperable exchange (e.g., EPCIS). FDA standards • Enhanced security guidance.

Medical devices

1. Determine FDA role: manufacturers and initial importers must register establishments and list devices; domestic distributors only storing/shipping do not register. FDA—Who must register.
2. Register/list via FURLS within 30 days of beginning covered activity, and renew annually after paying the FDA device establishment fee. How to register • When to register.
3. Check state device licensure (e.g., Texas Medical Device Distributor) in addition to FDA registration. Texas DSHS.

3PL‑specific guidance and controls

• Licensing triggers: any warehousing or logistics handling of prescription drugs for others without taking title generally requires a 3PL license in states that issue 3PL permits (e.g., CA, FL). CA 3PL • FL §499.01 (3PL).
• Contracts: define responsibilities with manufacturers/wholesalers/dispensers for DSCSA event handling (suspect/illegitimate product), recall execution, environmental controls, data retention, and EPCIS data support, consistent with FDA guidance. FDA DSCSA enhanced security.
• Technical controls for DSCSA: EPCIS 1.2+ for serialized events; authenticated/authorized partner directories; quarantine/workflows for suspect product; response within required timeframes to verification/trace requests. FDA standards.
• Responsible manager (state‑specific): e.g., CA requires a Designated Representative‑3PL as responsible manager at each 3PL location. CA DR‑3PL.

Sample multi‑state compliance checklist

• Confirm your role per DSCSA (WDD vs 3PL) and device status (manufacturer/initial importer vs distributor). FDA guidance • FDA devices.
• Secure state license(s): CA WDD/3PL (fees/bonds), FL WDD/3PL, MD WDD, device distributor where applicable (e.g., TX). FDA state links.
• Post surety bonds where required (e.g., CA WDD $100k; CA 3PL $90k or $25k if ≤$10M receipts; FL bond/security per §499.012). CA WDD bond • CA 3PL bond • FL §499.012.
• File FDA annual report (WDD/3PL) and verify appearance in FDA’s public database. Annual reporting • Database.
• Implement DSCSA interoperable data exchange and verification processes; target EPCIS for serialized data; document SOPs. Standards • Enhanced security.
• Train responsible persons (e.g., CA DR‑3PL) and complete required self‑assessments (e.g., 16 CCR §1784). 16 CCR §1784.

FAQs

Note: The following is provided for general information; always confirm with the cited official sources.

Do 3PLs ever have to register with FDA like device firms?

For drugs, 3PLs report annually to FDA under DSCSA (not the device establishment system). For devices, distributors do not typically register; initial importers and manufacturers must register and list. FDA reporting (WDD/3PL) • FDA devices.

What happened to “pedigree” laws?

PDMA’s paper pedigree concepts have been superseded by DSCSA’s national tracing framework. States may not impose different tracing requirements; follow DSCSA and FDA’s standards for interoperable data exchange. FDA PDMA Q&A • DSCSA law and policies.

Are national WDD/3PL standards in effect?

FDA has proposed national licensure standards; until finalized, continue to meet each state’s licensing requirements. FDA proposed rule.

Helpful official links

• FDA DSCSA main page: Title II (DSCSA) • Implementation status.
• FDA WDD/3PL state index + database: Check licensure.
• CA Board of Pharmacy: Homepage • Fees • WDD bond • 3PL bond.
• MD Board of Pharmacy: Establishments (incl. 3PL FAQ) • COMAR 10.34.22.
• FL DBPR Drugs, Devices & Cosmetics: Fees §499.041 • 3PL application.
• NABP accreditation (DDA, formerly VAWD): NABP reference.

Editor’s note and internal resources

For deep dives on a specific state, see our California guide for wholesalers and 3PLs. California Wholesalers & 3PLs: step‑by‑step.