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Guidelines for Pharmaceutical Packaging and Labeling

As a business that sells pharmaceutical products, it’s absolutely critical to understand the guidelines that govern the labeling and packaging of those products. The Food and Drug Administration is the regulator of labeling standards, and you’ll learn about their requirements for proper pharma packaging and labeling, as well as where to go for quality labeling solutions.

Heap of medical pills in white, blue and other colors.

Primary and Secondary Pharma Packaging Design Guidelines

Primary packaging is any that comes into direct contact with a pharmaceutical, such as a blister pack or pre-filled syringe. Secondary packaging is that which doesn’t come into direct contact with a product and would include a carton or an accessory like a syringe plunger rod.

The FDA requires that all primary and secondary packaging materials be suitable for their intended use. “Suitable for intended use” means that the packaging should not only protect the product’s form of dosage, but also be compatible with that dosage form. It’s also required that primary and secondary packaging be made of a material that’s considered safe to use, both with the product’s administration route and its form of dosage.

Primary packaging of pharmaceuticals should protect products from degradation and subsequent loss of efficacy due to:

  • Microbial contamination

  • Exposure to light

  • Oxidation

Primary packaging is also not permitted to interact with the product in any way that would alter its or its packaging’s essential properties, or release carcinogenic or mutagenic substances into the product.

The secondary packaging of any product should serve at least one of the following. It should provide:

  • Light protection for the system of packaging

  • Protection for any excessive emission of reactive gas in or out of the packaging system

  • Protect packaging systems needing additional handling protection or those which are flexible

  • Protection from microbial intrusion

  • Protection from excessive moisture or solvent transmission in or out of the packaging system

Medicine bottles

Labeling Guidelines

Any pharma label printing for pharmaceutical use is required by the FDA to be designed and applied in such a way that it can remain in place, and be legible in a number of environments like use and storage for the entire lifespan of the product.

All pharmaceutical labels need to display certain information on their labels, although the requirements for content varies from product to product. In general, a label must include:

  • Directions for use

  • Warnings

  • Active and inactive ingredients

  • Official product name

  • Dosage

The design of a label must be of a legible font type and size, be in appropriate language and format, and be made of approved materials. All labels should be thoroughly inspected to ensure accuracy and consistency of information.

The regulations surrounding the correct packaging and labeling of pharmaceutical products are many and complex, and can threaten manufacturing progress if not fully understood. GCB Solutions offers three decades of experience in pharma packaging solutions. Our materials and equipment meet FDA requirements, and we always aim to exceed your expectations. Schedule your consultation today by calling (904) 263-2804.


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