Every year, over 100 million drug shipments enter the United States. Most come from overseas manufacturers - from India, China, Germany, and beyond. But how does the FDA make sure these drugs are safe, effective, and not counterfeit? The answer isn’t just random checks. It’s a complex, high-stakes system built on data, risk, and strict rules.
How the FDA Reviews Every Drug Shipment
The FDA doesn’t physically inspect every box that arrives at a port. That’s impossible. Instead, it uses a smart, automated system called Entry Review. Almost all drug shipments - about 98% - get screened electronically before they even land. The system looks at the product type, manufacturer history, past compliance records, and even the port of entry. If something looks off, the shipment gets flagged.What triggers a flag? A few things: incomplete paperwork, a manufacturer with past violations, a product that’s been detained before, or if it’s a high-risk drug like insulin, antibiotics, or injectables. Around 15.7% of all entries get pulled for deeper review. These aren’t random. They’re targeted based on real data.
Once flagged, the shipment is held intact. No one can open or distribute it until the FDA makes a decision. That’s not a delay - it’s a legal requirement. The FDA has three ways to check: a field exam (physically looking at the product), a label exam (checking if the packaging and instructions meet U.S. rules), or sampling (taking a few units to test in a lab).
What Gets Detained - And Why
In 2022, 14.3% of drug shipments that were physically examined got detained. That’s more than 1 in 7. But detention doesn’t mean automatic rejection. Some shipments are fixed - labels are corrected, paperwork is updated, or the product is retested. But 67.8% of detained shipments were eventually refused entry.Why? Common reasons include:
- Products not made in registered facilities
- Missing or incorrect labeling (like missing lot numbers or expiration dates)
- Contaminated ingredients - like the valsartan recall in 2018, where cancer-causing impurities slipped through
- Unapproved drugs sold as generics
- Products that don’t match the approved application
One of the biggest problems? Active pharmaceutical ingredients (APIs). Over 88% of APIs used in U.S. drugs come from overseas. If the API is bad, the whole pill is bad. And APIs are harder to trace than finished pills.
The Secure Supply Chain Pilot Program (SSCPP)
Not all companies get treated the same. The FDA runs a special program called the Secure Supply Chain Pilot Program. It’s for manufacturers with a perfect track record - no violations, no detentions, no recalls - for at least three years. These companies can get their drugs cleared in 24 to 48 hours instead of 7 to 10 days.As of late 2023, only 27 companies qualified. Big names like Johnson & Johnson use it. They say it cuts their supply chain variability from ±5 days to ±8 hours. That’s huge for just-in-time manufacturing. But it’s not open to everyone. Smaller companies, especially generic drug makers, can’t meet the bar. And that’s creating a two-tier system.
The End of the 0 Loophole
Until October 2023, there was a loophole. Shipments under $800 - called “de minimis” - were exempt from FDA review. That’s how counterfeit pills, unapproved weight-loss drugs, and even pill presses slipped into the country. People thought they were buying from a small online seller. In reality, many were coming from unregulated factories in China or India.In October 2023, the FDA and Customs shut that down. Now, every drug shipment - no matter how small or cheap - must be reviewed. That added about 350,000 new entries to the FDA’s workload. It’s a major shift. The Partnership for Safe Medicines estimates $4.3 billion in counterfeit drugs entered the U.S. in 2022. Most of those came through that $800 loophole.
Who’s Getting Hurt - And Who’s Helping
The new rules aren’t just affecting shady sellers. They’re hitting researchers, small biotech firms, and academic labs too. Scientists importing biological samples for research now face delays of 3 to 5 days and costs of $285 to $420 per shipment. The Association of American Medical Colleges says 63% of institutions are seeing significant delays.At the same time, big pharma companies are happy. Their compliance teams have more structure. The electronic entry system, launched in 2021, gives clearer feedback. Experienced importers say building a relationship with a specific FDA reviewer at a port can cut processing time by 22% to 35%.
But for small businesses? It’s rough. The cost of hiring a customs broker runs $285 to $450 per entry. And one mistake - wrong product code, missing registration number - can delay a shipment by nearly 5 days. According to CBP data, 28% of delays come from incorrect coding. That’s not incompetence. It’s complexity.
What’s Coming Next
The FDA isn’t standing still. It’s rolling out new tools:- AI risk tools - aiming to improve detection accuracy by 25% by 2025
- Blockchain pilots - testing digital ledgers to track drug movement from factory to pharmacy
- Expanded SSCPP - going from 27 to 50 participants by mid-2024, including contract manufacturers
- International alignment - working with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to match standards with Europe and other countries
Still, the system has gaps. The Government Accountability Office found only 4 of 17 key performance measures from the 2012 law have been fully implemented. And while the FDA inspects 1.2 million entries a year, it’s still only checking 1.2% of the total drug shipments entering the U.S. That means most drugs are cleared without ever being touched.
That’s the trade-off: safety vs. speed. The FDA can’t inspect everything. So it tries to catch the worst risks. Sometimes, it misses. But the system keeps getting smarter.
What Importers Need to Do
If you’re shipping drugs into the U.S., here’s what you need to get right:- Make sure your facility is registered with the FDA
- List every product you’re shipping
- Use the correct product code (FDA’s 4-digit code, not your internal SKU)
- Include a valid Affirmation of Compliance (A of C) with every shipment
- Submit your entry at least 15 minutes before arrival - no exceptions
Keep records for three years. One error can trigger an Import Alert - meaning every future shipment gets automatically detained until you prove you’ve fixed it. That’s a nightmare for supply chains.
Use the FDA’s Electronic Entry Interface Repository (EEIR). It’s updated every two weeks. And if you’re stuck, call the port-specific contact center. Average response time? Just 1.8 hours.
Bottom Line
The FDA’s import system isn’t perfect. It’s under-resourced, complex, and sometimes slow. But it’s also the most advanced drug safety net in the world. The elimination of the $800 loophole was a turning point. The Secure Supply Chain Pilot shows that compliance can be rewarded. And new tech like AI and blockchain could make it even stronger.For patients, that means fewer fake pills. For manufacturers, it means clearer rules - if you’re willing to play by them. And for everyone else? It’s a reminder: the drugs you take didn’t just appear on a shelf. They passed through a system designed to protect you - even if it’s not always visible.
How often does the FDA inspect imported drugs?
The FDA physically inspects only about 1.2% of the 100 million+ drug shipments entering the U.S. each year. The rest are reviewed electronically using risk-based tools. High-risk products - like insulin, antibiotics, or those from past-violating manufacturers - are more likely to be selected for physical inspection or sampling.
What happens if a drug shipment is detained?
If a shipment is detained, it’s held at the port until the FDA makes a decision. The importer can fix the issue - like correcting labeling or submitting missing paperwork - and request re-inspection. If the problem can’t be fixed, the shipment is refused entry and must be destroyed or returned at the importer’s expense. About 67.8% of detained shipments are ultimately refused.
Can I still import drugs from China or India?
Yes, as long as the manufacturer is registered with the FDA, the product is approved or listed, and all documentation is complete. Over 88% of active pharmaceutical ingredients used in U.S. drugs come from China and India. The issue isn’t the country - it’s compliance. Facilities with repeated violations may be placed on an Import Alert, which blocks all future shipments.
What is the Secure Supply Chain Pilot Program (SSCPP)?
The SSCPP is a voluntary program for manufacturers with a flawless compliance record for at least three years. Approved companies can import up to five products with minimal inspection - clearance takes 24 to 48 hours instead of 7 to 10 days. As of late 2023, only 27 companies qualified, including major firms like Johnson & Johnson.
Why did the FDA eliminate the $800 exemption?
Before October 2023, shipments under $800 didn’t need FDA review. This loophole was exploited to smuggle counterfeit medications, unapproved drugs, and even pill presses into the U.S. The FDA closed it to stop dangerous products from entering through small online packages. The change added roughly 350,000 new entries to the inspection system annually.
How can I avoid delays when importing drugs?
To avoid delays: use the correct FDA product code, submit complete and accurate paperwork (including Affirmation of Compliance), ensure your facility is registered, and submit your entry at least 15 minutes before arrival. Errors in labeling or registration cause nearly 40% of delays. Working with an experienced customs broker and building a relationship with FDA reviewers at your port can also reduce processing time.