The FDA’s import rules get tougher for 2016. It is time to get familiarized with them.

The FDA has, in association with the Customs and Border Patrol Service (CBP), become more and more stringent of late with its insistence on the adherence to procedures and submission of information. Noncompliance with the FDA’s requirement could invite serious actions and severe penalties.

The FDA and the CBP have become so strict of late in their function that they could delay, detain or refuse shipment of firms that fail to properly implement the two agencies’ import and export program requirements. The legal and prior notice information requirements have to be complied with very strictly.


New rules for 2016

For 2016, a new layer of stringency has been added, what with the agencies demanding adherence to the Automated Commercial Environment (ACE) entry filing system for importers that enter American shores. Some of the consequences of not adhering to the ACE:

  • Any importer who fails to do this can have its shipment barred from entry
  • Such an importer could also face a monetary penalty of $10,000 for an offence
  • The ACE empowers the FDA to stop a ship even before it is loaded
  • The CBP can fine three times the value of the shipment if the FDA decides that the importer should bring the products back to the port of entry after it has received a release, but cannot find the product that has already been sold.

Understanding the rules for import

Are you an importer who faces issues with the FDA’s import rules? Do the new rules cause alarm in you? Are you looking for expert training on how to handle this aspect of the FDA? A two-day, in person seminar from GlobalCompliancePanel, a leading provider of professional trainings for the FDA-regulated industries, is the solution.

The Director of this seminar, Casper Uldriks, who has been an ex-FDA expert and a former Associate Center Director of CDRH, brings over three decades in handling all aspects of the FDA. This seminar, details of which can be had from, is the ideal leaning for importers who are muddled with the new rules from the FDA.

Uldriks will cover the following important areas during this session:

  • FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
  • Import Delays Import Alerts Detention Refusals
  • Foreign Inspections FDA 483 – Inspectional Observations
  • FDA Warning Letters and Automatic detention
  • Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
  • FDA Export Program Special Import Issues


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Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands.

The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for their potency and capability for being developed into drugs, and goes all the way up to the consumer and even after.

Drug supply chain is crucial because a weak cog in this link can make the drug spurious and reduce its efficacy. Worse, when drug supply chain integrity is awry, it gives opportunity for the drugs to become illicit and reach the wrong hands, ending up being put to the wrong use.

Dangerous consequences for society at large

This makes the integrity of the drug supply chain a matter of utmost importance to everyone concerned -the medical fraternity, users and their families, the logistics sector, the drug industry, the retail drug sector and everyone else. It is everyone’s duty to ensure drug supply chain integrity.

When the wrong drug (meaning a drug that is not prescribed) is given out to the patient, it accounts for loss of drug supply chain integrity. In many cases, as the ones relating to the massive scale of the recent diversion of sales of the drugs Avastin and Altuzan, the financial loss can be colossal. It was estimated in 2012 that the American economy stands to lose at least a billion dollars a year because of slackness in drug supply chain integrity.

The Prescription Drug Marketing Act of 1987

Legislative efforts to bring about drug supply chain integrity can be traced to the presidency of Ronald Reagan, who passed the prescription drug marketing act (PDMA) of 1987, which sought to regulate the drug supply chain. This was at the peak of the drug threat in the US. It was believed that bringing about drug supply chain integrity could ease the problem.

The NABP-Accredited-Verified Wholesale Distributors Program

This Act gave way to the NABP-Accredited-Verified Wholesale Distributors Program (VAWD), which was passed mainly because the PDMA did not fully succeed in its mission of bringing about the desired levels of drug supply chain integrity. Following the reemergence of spurious drugs in the market in the 2000’s, this program was initiated by the NABP. It strengthens the existing PDMA and seeks to bring about drug supply chain integrity by:

  • Reviewing sections of the existing law and making them stronger
  • Verifying licensures
  • Making more rigorous inspections and checks of facilities

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