The pharmaceutical sector is one of the most heavily scrutinized healthcare industry divisions in terms of the strictness of regulations around it. It makes sense, too — since one wrong ingredient or the slightest bit of carelessness in the manufacturing process could threaten countless lives.

That is why the packaging trends within the pharma sector have to conform to a particular set of sustainability and safety standards.

Keeping those regulations and guidelines into consideration, this article goes over how companies can improve their packaging design to represent their products better and obtain FDA approval.

Pharmaceutical Packaging Design — Key Factors

There’s a lot to cover here, but the essential must-haves in pharmaceutical packaging design are these: 

  1. Safety
  2. Readability
  3. Sustainability 

Designers need to work with a sacred level of moral responsibility to ensure the packaging clearly and accurately represents the drug. Failure to do so could lead to severe (possibly fatal) consequences.

1. Safety

First and foremost, there can be absolutely no compromises on safety. The medicine needs to be safe to consume without the packaging leaching in any harmful contaminants. Some medicines have a relatively higher degree of tolerance to such risks, whereas some drugs are sensitive enough to require temperature controlled packaging.

Pharmaceutical companies or CMOs should follow the QBD (Quality by Design) approach, which uses analytical methodologies and risk management to design high-quality medication dispensing bottles.

You should also stick to packaging materials that are officially approved to comply with FDA’s standards. Examples include certified types of medical plastics, impermeable printing ink, etc. 

2. Sustainability

If a drug treats or saves a human life but simultaneously chips away at our planet’s wellbeing, it isn’t such a “sustainable” tradeoff.


In the past decade, the world has opened an eye of concern to the detrimental effects of using non-biodegradable materials. Sustainability means working around these negative externalities by using recyclable materials instead of — for example — single-use plastics. 

Pharmaceutical packaging should mainly consist of biodegradable and recyclable materials to promote environmental sustainability. Medicine shouldn’t just save lives but also the planet.

3. Readability

There’s no such thing as “too much information” when it comes to pharmaceutical packaging. Companies should include as much helpful information as they can fit into the packaging to make sure anyone who buys it can fully understand the side effects, dosage, risk factors, and recommendations associated with its use.

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Every drug packaging material should contain at least the following information:

  • Expiry date
  • Usage direction
  • Drug name
  • Batch number
  • Special storage conditions that the drug may require
  • Supplier’s or manufacturer’s address
  • Active ingredients

Next time you’re about to take a dose of aspirin or ibuprofen, grab the box and see how much of this info you can find on the packaging.

You might have to look very closely due to the small font size, but that’s only because the tight regulations around the sector require companies to add all necessary info no matter how small of a package the drug comes in.

Regulatory Guidelines for Primary and Secondary Packaging of Pharmaceutical Products

Due to the massive responsibility attached to pharmaceutical products, it’s critical for pharma companies to understand and implement the regulatory guidelines around their packaging and labeling.

Packaging Design Guidelines 

Anything that comes in direct contact with drugs is known as primary packaging. Examples include pre-filled syringes, blister packs, and tablet bottles. Secondary packaging, on the other hand, doesn’t come into contact with a pharmaceutical such as cartons.

As per FDA’s requirements, all materials used in packaging (primary and secondary) must be suitable for their intended use. This means the materials should be safe to use and protect the product’s form of dosage.

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The packaging should also protect drugs from loss of efficacy and degradation through light exposure, oxidation, or microbial contamination.

The packaging must also not contact and interact with the pharmaceutical product in a way that introduces carcinogenic or other harmful substances to it or alters its essential properties.

The secondary packaging of pharmaceutical products should serve one or more of the following purposes:

  • Microbial intrusion protection
  • Protection from reactive gasses that may emit out of the package
  • Protection from solvent transmission getting in or out of the packaging system
  • Light protection for packaging system
  • Protection from excessive exposure to moisture 

Pharmaceutical Packaging Design: Conclusion

By understanding and implementing all of the above information into the design and manufacturing process, pharmaceutical companies can highly improve the usability, safety, and sustainability of their drug packaging.

Regulatory guidelines also help expand the lifespan of pharmaceutical products with a lower rate of degradation to ensure the highest possible efficacy for the final user.