Rx-to-OTC Packaging Considerations

Posted by Rob Helmke | Monday, November 13, 2017 0 Comments

In recent years, many companies have begun making the “Rx-to-OTC switch,” the process of transferring a proven prescription-only drug (Rx) to nonprescription, over-the-counter (OTC) status. Making the shift to OTC availability involves a scientifically rigorous, data-driven process, and medications must meet strict requirements, including a considerable margin of safety, proven efficacy, and comprehensive and clear labeling practices.

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Many drugs that were previously available only by prescription can now be easily obtained OTC. This offers a range of benefits for consumers: convenience, a wider range of treatment options, and fewer required doctor visits. Pharmaceutical companies, however, are now facing some new challenges, as they must secure FDA and FTC compliance for these new OTC drugs, educate consumers and pharmacists, ensure proper drug use, and stand up to generic competition.

For a prescription-only drug to make the switch to OTC, it must have a low potential for misuse or abuse, and consumers must be able to easily self-diagnose the ailment it treats. It also must be able to be administered without professional assistance and include comprehensive, clear labeling with relevant drug information and directions.

Employing smart packaging solutions can go a long way in ensuring that these requirements are met.

OTC Packaging Considerations 

Packaging may fall far down on a pharmaceutical company’s Rx-to-OTC to-do list, but packaging decisions can actually have a major impact on the safety and market success of OTC drugs by enhancing branding initiatives, improving customer experience, and helping to achieve Rx-to-OTC clearance.

Consumer Appeal and Brand Image

To maximize brand awareness and consumer appeal, pharmaceutical companies are putting more consideration into packaging than ever before. Many companies are now completely abandoning standard carton or bottle designs and instead pursuing unique solutions to help products stand out in a market saturated with generics. More emphasis is now being placed on eye-catching graphics, unique shapes, and value-added features not offered by traditional packaging methods.


Security considerations must also be taken into account to ensure optimal consumer safety.

Reliable tamper resistance, for instance, is critical in OTC drug packaging to ensure that products cannot be accessed or tampered with in any way, thereby safeguarding consumers’ health and safety. The welded seals on Flonase® allergy medication clamshell packaging, for instance, maintain product integrity and give consumers peace of mind that the drug is safe and sterile. Child-protection features, like press-and-twist closures, must also be considered.

Labelling and IFU

The FDA sets forth strict requirements for OTC drug labeling. Drug facts must be clearly outlined, specifying ingredients, instructions for use (IFU), and side effects, and font size and spacing must meet specific guidelines. Depending on the medication, listed drug facts may be extensive, and often require a specialized packaging solution in order to include them all.

These are just a few of the many considerations pharmaceutical companies must keep in mind when designing custom medical packaging. Other key aspects include the consumer experience as a whole, which goes deeper than branding and shelf appeal alone; connectivity capabilities, wherein packaging can be used to redirect users to related support programs and informational web applications; and, perhaps most importantly, manufacturing concerns, such as the ability to bring an OTC packaging design to full-scale, fully automated manufacturing levels.

Thermoformed OTC Packaging Solutions From Plastic Ingenuity

Flonase3.jpgPartnering with an experienced thermoformer who can create custom medical device and OTC drug packaging for your specific needs will help ensure optimal efficiency and value. The thermoforming method allows for a range of benefits, including:

  • Easily achievable unique shapes for brand enhancement
  • Ability to incorporate consumer-use considerations like easy-open tabs and form-fitting shapes
  • High-quality graphics, which can be achieved with inserts and direct-to-plastic printing
  • Optimization of packaging billboards for inclusion of both branding graphics and required drug facts labeling
  • Tamper-resistance security features that can be included with ease
  • Suitability for both high-speed and automated packaging lines

An industry-leading custom thermoformer and packaging manufacturer with 45 years of experience designing and manufacturing high-quality medical packaging, Plastic Ingenuity has worked with some of the largest medical companies and brands in the world.  Offering medical device packaging and emergency response packaging solutions in addition to OTC options, our team is dedicated to optimizing safety and value in the pharmaceutical and medical spheres. We’ve won numerous awards for such work, most recently a 2016 WorldStar Award for our Flonase® OTC packaging.

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To learn more about how the top pharmaceutical companies are automating their packaging systems, download our free eBook, “How the Top Pharma Brands are Effectively Using Automation.” Or, to speak with one of our experts about a package automation solution for your application, reach out to the team today.

Topics: Thermoformed Packaging, Thermoformed OTC Packaging, OTC Packaging, Pharmaceutical, FDA, RX-to-OTC