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Understanding FDA Pharmaceutical Labeling and Packaging Requirements

How to Ensure Your Pharmaceutical Product Meets FDA Regulations

Pharmaceutical Packaging and Labeling FDA

When it comes to packaging pharmaceutical products, there are a lot of factors to consider. Notably, it’s imperative that your packaging and labeling align with FDA regulations; however, you also must ensure your packaging is user-friendly, efficient, and economical, and sends the right message on the shelf. Learn more about the basics of pharmaceutical packaging below – and of course, don’t hesitate to contact us if you have any questions about finding the right solution for your product.

Basic Pharmaceutical Packaging Requirements

At its most basic, pharmaceutical packaging must protect its contents from light, moisture, and impact damage, ensuring it arrives safely to its point-of-sale. In addition, there are several FDA requirements that apply to all pharmaceutical products. For example, all over-the-counter products must have a Drug Facts label, which contains the following:

  • The product’s active ingredients

  • The purpose of the product

  • The uses of the product

  • Relevant warnings and side effects

  • Dosage instructions

  • Inactive ingredients

All of this information must be printed clearly and legibly and should appear on the outside container of the packaging. The FDA provides clear formatting requirements for the Drug Facts label, including font size and line-height.

Most products also require tamper evidence that makes it visibly clear if the product has been opened. This requirement applies to drugs as well as to any cosmetic products, contact lens solutions, and other over-the-counter pharmaceutical products. The few exceptions to this rule include dermatologics, dentifrices, insulin, and throat lozenges.

Additional FDA Requirements for Pharmaceutical Products

Depending on the product you’re packaging, there may be additional FDA requirements to consider. For example, some products may require child-resistant packaging, per the Poison Prevention Packaging Act. These package designs may make use of safety caps or single-dose blister packaging to make it difficult for children to gain access to the package’s contents. Products requiring child-resistant packaging include aspirin, naproxen, supplements and drugs containing iron, and mouthwash. If a package is child-resistant, this should also be noted on the product’s label to make the information easily accessible to parents.

Do These Requirements Apply to My Cosmetic Product?

FDA regulations state that any cosmetic product that advertises “therapeutic use” or “affecting the structure or function of the body” – for example, some skincare products like dandruff treatment or skin protectants – must be classified as a pharmaceutical product. These products must be FDA-approved, while cosmetic-only products are simply FDA-regulated.


Whether you’re in need of packaging, labeling, printing technology, or a complete consultation, GCB Solutions can help. With our expertise in pharmaceutical packaging, our team is ready to find the right solution for your product. Contact us today at (904) 263-2804 or schedule a free consultation to learn more.


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