DSCSA, state by state.
The Drug Supply Chain Security Act sets the same tracing rules in every state, while each state decides which agency licenses wholesale distributors, third-party logistics providers and pharmacies.
People search for DSCSA rules in their state, and the answer has two halves. The tracing rules are federal and the same everywhere. Licensing is the state's: each state decides which agency licenses wholesale distributors, third-party logistics providers and pharmacies. That licence is what makes a firm an authorized trading partner under DSCSA.
DSCSA by state, in three facts.
US DSCSA · one national tracing standard · licensing set by each state · licences reported to FDA every year.
DSCSA sets one national standard for tracing prescription drugs: a state may not set tracing requirements that are inconsistent with, stricter than or in addition to the federal ones.
Source: 21 U.S.C. §360eee-4Third-party logistics providers that handle prescription drugs must be licensed and report their licensure to FDA every year.
Source: FDA, annual reporting by wholesale distributors and 3PLsDSCSA trading partners keep transaction information and transaction statements for at least 6 years.
Source: 21 U.S.C. §360eee-1
Two halves, one compliance file.
Federal: tracing
Product identifiers, electronic transaction data, verification, suspect-product handling and six-year records. A state may not set tracing requirements that differ from the federal ones.
State: licensing
Each state licenses or registers wholesale distributors and pharmacies. Rules for 3PLs vary more. The agency differs too: a board of pharmacy in California and New York, a health department in Texas and New Jersey, a business regulator in Florida.
Both: authorized trading partners
Under DSCSA you may trade only with partners that hold a valid licence or registration. So the state licence is part of your federal compliance, for you and for everyone you buy from or sell to.
Both: annual report to FDA
Wholesale distributors and 3PLs report their state licences to FDA every year. FDA publishes the reports in a searchable database.
The timeline, as it stands.
The federal dates do not vary by state. Check renewal dates with each state agency, because those do.
Three moves that de-risk the deadline.
List every state you touch
Include states you ship into and states you only invoice into. Several states, New York among them, register out-of-state firms on that basis.
Find the right agency in each
It is often the board of pharmacy, but not always. FDA keeps a list of the state agency responsible for licensing drug distributors in every state.
Keep one partner file
For each supplier and customer: the state licence, the date you checked it, and its FDA report. That file answers the authorized-trading-partner question in any state.
The tracing half, done once.
Because the tracing rules are federal, one system serves every state you operate in. Aeroz ties each unit's physical identity to its transaction record, so the evidence you produce in California is the same evidence you produce in New Jersey.
The same federal rules apply in every one.
States in bold have a guide to who licenses what. For the others, the federal requirements on this page apply in full, and FDA's wholesale distributor and 3PL reporting page shows who is licensed where.
- Alabama
- Alaska
- Arizona
- Arkansas
- California
- Colorado
- Connecticut
- Delaware
- District of Columbia
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Indiana
- Iowa
- Kansas
- Kentucky
- Louisiana
- Maine
- Maryland
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- Missouri
- Montana
- Nebraska
- Nevada
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Vermont
- Virginia
- Washington
- West Virginia
- Wisconsin
- Wyoming
DSCSA by state, answered.
Are DSCSA requirements different in each state?
The tracing requirements are not. DSCSA sets one national standard and a state may not add different tracing rules. Licensing of wholesale distributors, 3PLs and pharmacies is set by each state.
Which agency licenses drug wholesalers in my state?
It depends on the state. Many use the board of pharmacy. Texas uses the Department of State Health Services, Florida the Department of Business and Professional Regulation, and New Jersey the Department of Health. FDA lists the responsible agency for every state.
Do I need a licence in every state I ship to?
Often, yes. Many states license or register out-of-state wholesale distributors that ship into them. Check each destination state's agency.
Which states have an Aeroz guide?
California, Texas, Florida, New York, New Jersey and Pennsylvania so far. Each guide is published once its licensing facts have been checked against the state agency.
Know exactly where you stand — in 14 days.
A fixed-fee Aeroz audit maps your products against DSCSA requirements and state licensing and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.