Licensing in a cross-border medicine supply chain
Which licences matter at each step, and which ones you can check yourself.
Reviewed by the Reserve Meds clinical operations team on 18 October 2026. Sources accessed 18 October 2026.
The short answer
In a cross-border supply chain, several parties hold different licences: the manufacturer's product is approved by the FDA, the US wholesale distributor holds a state licence and reports it to the FDA, the destination hospital or importer needs the regulator's permission, and the treating doctor holds a medical licence. A coordinator should tell you who holds each one.
- Product: approved by the US FDA for the use in question.
- US supply: a licensed wholesale distributor that reports to the FDA.
- Destination: the hospital or importer gets the regulator's permission.
- Prescriber: your treating doctor, licensed where they practise.
Step 1: the product
The starting point is a medicine approved by the US FDA for the use your doctor intends. If it is not approved anywhere, it is investigational and follows a different route.
Investigational medicines are a different route. In the US, expanded access needs the agreement of a licensed physician, an Institutional Review Board and the company that makes the product; without the company's cooperation there is no access.[1]
Step 2: the US supplier
US wholesale drug distributors and third-party logistics providers must be appropriately licensed and must report their licensure to the FDA every year to count as authorized trading partners under that law. The FDA publishes the reports in a searchable database that is updated every business day. A listing is not an FDA licence or approval in itself: the licence is issued by the state, and the database helps you see that a company has reported one.[2]
In the United States, the Drug Supply Chain Security Act sets out an electronic, interoperable way to identify and trace certain prescription medicines at the package level as they move through the supply chain, to keep harmful products out and to find and remove them quickly if they get in.[3]
Step 3: the destination country
Rules for unregistered medicines are set by each destination country. In Bahrain, for example, NHRA Circular 41 of 2020 requires a hospital to obtain the authority's permission before it issues a purchase order for a non-registered medicine, and to transport and store the product in containers that follow the manufacturer's recommended conditions.[4]
Other countries have their own permits and procedures, and the treating hospital usually knows which one applies. Whoever files the request in your country must be entitled to do so under local rules.
Step 4: the prescriber
The FDA's advice to consumers is that a legitimate seller of prescription medicines always requires a doctor's prescription, and that a seller who does not ask for one is a warning sign.[5]
Your treating doctor writes the prescription and the medical justification, and stays responsible for your care. A coordinator should never take that role.
Where a coordinator fits
A coordinator is not one of the licensed links above. Its job is to connect them: to make sure the supplier is licensed, the documents are complete, the permit is in place before anything ships, and you know what is happening.
Reserve Meds is a digital health company, not a pharmacy and not a wholesaler. Medicines are supplied through a US-licensed pharmaceutical wholesale partner, and you can ask us for that partner's licence details.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate the route with your treating doctor and hospital, prepare the paperwork the regulator or hospital asks for, and arrange supply once approval is in place. Your doctor prescribes and makes every medical decision. You can ask us for our wholesale partner's licence details, and you get your quote and timeline estimate in writing before you commit.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Is Reserve Meds a pharmacy?
No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner.
How can I check a US wholesale distributor?
Ask for its name and state licence. US wholesale distributors report their licensure to the FDA every year, and the FDA publishes a searchable database of those reports.
Who applies for the import permit?
It depends on the country and route. In Bahrain, for example, the hospital must get the authority's permission before issuing a purchase order for a non-registered medicine.
Who prescribes?
Your treating doctor. A legitimate seller of prescription medicines always requires a doctor's prescription.
Sources for these answers: [2, 4, 5]
Sources
All sources were opened and checked on 18 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- US FDA: Expanded Access, Information for Patients (accessed 18 October 2026)
- US FDA: Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers (accessed 18 October 2026)
- US FDA: Drug Supply Chain Security Act (DSCSA) (content current as of 16 October 2025) (accessed 18 October 2026)
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines (accessed 18 October 2026)
- US FDA: How to Buy Medicines Safely From an Online Pharmacy (content current as of 2 January 2025) (accessed 18 October 2026)
Related
- Why transparency matters
- Named-patient access, explained
- Questions to ask before you start
- Checklist for patients and families
- Reserve Meds vs Everyone.org: which fits a Gulf family?
- Answers to common access questions
- اقرأ هذه الصفحة بالعربية
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.