What is Tamper-Resistant Packaging?

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In 1982 there was a crisis. A depraved madman had laced many Tylenol capsules with potassium cyanide. The ensuing deaths and shock at such a malicious and evil act swiftly brought an industry and FDA forces to action and together started enforcing strict guidelines for tamper-evident packaging.

There can be some confusion as to what ‘tamper-evident’ or ‘tamper-resistant’ means. We’d like to concisely sum up what these terms entail. If you have a product that needs this layer of protection, then you can make sure you’re following FDA guidelines and using the proper system.

What needs tamper-resistant packaging?

The FDA guidelines for tamper-resistant packaging (hereafter referred to as TRP) are pretty clear that only over-the-counter (OTC) human drug products (HDP) are in need of TRP. Tamper-evident packaging (TEP) has no FDA guidelines but is used widely in the packaging industry as an added measure of tampering proof. Oh, and just as a heads-up, this article will be loaded with acronyms (or as I like to say TAWBLWA… actually never mind, let’s not use that, it’s just ridiculous).

TRP can be and has been widely applied to many other industries where it’s not required by law. TRP offers a sense of security for both the manufacturer and buyer. So while it’s only required for human OTC drugs there is nothing saying you can’t use it for your customers’ peace of mind, or your own.

How it’s packaged

FDA rules for this are surprisingly simple for OTC drugs:

  • Two-piece hard gelatin capsules need a minimum of two TRP features
  • Everything else needs only one TRP feature

The real amazing thing here is that a government rule can be so concise! Good job anonymous FDA legalese writers.

What counts as TRP

Each of the following TRP options needs to be paired with another TRP measure such as a statement on the label or package itself. Something like: “Do not use if seal is broken or missing.”

  • Shrink wrap
  • Blister packs
  • Bubble packs
  • Shrink bands
  • Individual pouches (paper, foil, or plastic)
  • HIS liners
  • Caps with breakable ring
  • Sealed metal tube
  • Aerosol containers
  • Sealed metal cans

What counts as TEP

Not to say these aren’t great options, but if you’re distributing an OTC drug, they will not pass FDA TRP regulations.

  • Tape seals
  • Sealed paperboard
  • PS (Pressure Sensitive) liners

Conclusion

Unless you are manufacturing OTC drugs, there is a good chance you’ll never need to meet the requirements of tamper-resistant packaging by law but it’s good to see its principals adapted to so many different industries. Ultimately TRP and TEP show how much you care about the safety, trust, and customer experience of your products. Given the gratuitous use of acronyms, I feel like I should end on one so as the author John Green says DFTBA, Don’t forget to be Awesome!