Necessary Considerations for Thermoformed OTC Packaging

Necessary Considerations for Thermoformed OTC Packaging

Thursday Jun 3rd, 2021

In the last several years, there has been a shift in the pharmaceutical industry. Drugs that were previously only available through a prescription have recently become available over the counter (OTC). It's a long process to transition a drug from prescription-only to OTC availability. The packaging, active ingredients, and drug interactions must undergo a rigorous testing process to determine the best safety directions and labeling. 

The benefits of the "Rx-to-OTC" switch are passed onto the consumer. Patients now have access to a wide array of treatment options, have to spend less time at the doctor's office, and can enjoy the convenience of picking up medicine at a moment's notice from the regular grocery store. 

Before a prescription-only medication can be approved for OTC status, it has to be empirically understood that it's unlikely to be misused or abused, and it needs to be able to treat a mild condition that a layperson can safely self-diagnose. 

As mentioned above, one of the most significant considerations when transitioning a drug to OTC availability is the packaging. Packaging is how the product is delivered to the customer. It sets the tone for the product and helps ensure that it meets the safety and consumer guidelines set by the FDA and FTC. 

Appeal to Consumers and Set Brand Image

With generic OTC drugs soaring in popularity in response to the Rx-to-OTC transition, pharmaceutical companies have more competition on the market. The industry is deviating from conventional product designs and innovating unique packaging options so that their product stands out. We can expect OTC packaging to feature bold colors, exciting graphics, and unconventional shapes. 

Tamper-Proof Security

One of the most crucial safety requirements for OTC medications rests in its security. Before purchase, customers must receive the utmost confidence that their products have not been tampered with. Many manufacturers have added welded seals on their clamshell packaging to fully protect their products from tampering. Other tamper-proof packaging considerations include child-proofing. 

Labeling Needs

The FDA has stringent regulations regarding the labeling of over-the-counter products. The labels must clearly articulate the active ingredients and instructions for use, also known as IFU. The labels must also include potential side effects. The actual font, size, and spacing must also meet the FDA's guidelines. 

How Thermoforming Can Help OTC Manufacturers Meet Packaging Requirements

OTC manufacturers have pursued worthwhile partnerships with experienced thermoformers qualified to create custom packaging and eye-catch design elements for their products. Thermoforming offers benefits such as:

Munot Plastics 2021 Infographic

  • It's relatively easy to create unique product shapes
  • Ability to take consumer needs into account, such as easy-open tabs and form-fitting shapes
  • High-quality inserts
  • Tamper-proof security considerations
  • Ease of implementation for automated packaging lines
  • Packaging billboards can easily incorporate branding graphics and drug labeling facts


For more information about the benefits of thermoforming for the medical and pharmaceutical industry, don't hesitate to reach out to our team today!

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