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The Hidden Costs of Importing Injectables

For practices that are willing to shrug regulations, imported prescriptions can be very cheap, but over the long term, the real costs might be much higher than they expect. The practice of re-importing drugs made in the United States is explicitly illegal. Importing foreign sourced drugs can be legal if regulations are followed, but most often, they aren’t. As a result, many doctors in the United States are prosecuted criminally for doing it incorrectly. The FDA’s drug regulatory authority requires approval for drugs that are imported prior to sale or distribution in the United States.

Importing Foreign Sourced Drugs

When doctors import foreign-sourced prescription drugs, they’ll need to be able to answer the following questions prior to making a purchase:

1.     Is the drug legitimate or is it counterfeit? Counterfeit can mean the drugs were made, processed, packed, repacked, or labeled by someone different than what is declared on the drug’s label – it could be authentic product but counterfeit because of the label.

2.     Is the drug formulated the same as the FDA-approved version? The products may be may be legitimate-but-unapproved versions that are not allowed for sale in the United States.

3.     Is the drug from an FDA-approved (and registered) facility? They also may have been improperly stored or handled while moving through third party international supply chains.

4.     Did the facility list the drug correctly?

5.     Does the drug bear the proper labeling approved for the United States?

Simply receiving prescriptions in the mail after they passed through FDA or Customs doesn’t constitute approval. An FDA import release doesn’t shield an enforcement action. The burden for ensuring a drug is legal always falls on the persons selling, buying, importing and using it. Without approval, everyone can face prosecution – the importer, the drug manufacturer, or later purchasers and marketers of the drugs. So the first rule is to NOT re-import a prescription drug made in the United States. That is illegal. The second is to not import foreign-sourced prescription drugs without getting help, because the degree of necessary due diligence is extremely high.