The United States has no comprehensive legal legislation regulating the packaging industry across every state. However, through the FDA, they do have the authority to regulate food, drug, and cosmetic packaging to ensure that it meets standards of consumer safety and confidence.
So, it’s important for US pharmaceutical packaging companies to understand the regulations they have to abide by – including essential safety features such as child resistance and tamper evidence, as well as which materials can and cannot be used in pharma packaging.
Here, Origin breaks down the FDA guidelines* for regulations around pharma packaging in the US.
US pharma packaging regulations
FDA guidelines governing the distribution of pharma packaging and labelling in the US can be broken down into key areas:
Primary packaging
Primary packaging – the products that come into direct contact with medicines – is required by the FDA to be suitable for its intended use. This simply means it is designed with the medicine in mind and will not put the product or patient at risk.
For example, blister packaging not only provides a suitable material for protecting tablets but is also designed with administering tablets in mind. The patient simply pierces one blister segment to access the accurate medication dose.
Primary packaging is also designed to protect against anything that can degrade the quality of the medication – including contamination and exposure to light or air. The packaging itself must also be able to interact with the medication without impacting its quality.
Secondary packaging
The FDA requires secondary packaging – products designed to store primary packaging products to avoid direct contact with medication – to provide many of the same functions as primary packaging. These include being suitable for its intended use as well as protecting contents from light, air and contamination.
However, secondary packaging may also be expected to protect against excessive moisture as well as provide an additional barrier against impact or handling for sensitive or flexible products.
Labelling
US pharma packaging regulations require all labels to meet certain guidelines, too, including staying firmly on packaging and remaining legible in a large font. This allows patients to access the information needed for safe consumption.
There are also requirements around this patient information. The FDA requires pharma packaging labels to display certain data – including how to use the medication and exact dosages, usage warnings and a complete list of ingredients.
Specific US packaging regulations
In addition to the general rules governing the use of pharma packaging, there are also specific FDA regulations that must be followed.
Child-resistant packaging
The Poison Prevention Packaging Act of 1970 is designed to protect children from accessing and ingesting potentially dangerous substances in the household, such as food products, cosmetics, and pharmaceuticals.
As such, pharma packaging must follow regulations regarding child-resistant design. These may include features such as safety caps – to prevent children from opening pharma products – as well as using single-dose blister packaging, such as peel-push blisters.
The 16 CFR §1700.14 section of the Poison Prevention Packaging Act lists over-the-counter products that require child-resistant packaging, including aspirin, ibuprofen, and mouthwash. Section 1700.15 also includes a full overview of necessary performance specifications for packaging to be considered child-resistant.
Through their draft ‘Child-Resistant Packaging Statements in Drug Product Labelling’ Guidance for Industry documents, the FDA has now defined their requirements for child-resistant packaging. Applicants, manufacturers, wholesalers, and packaging operations must now follow their regulations on how products must be labelled if packaging is child resistant.
Information on whether packaging is child-resistant or not is also supposed to be added to the labels, for healthcare professionals’ and patients’ peace of mind.
Tamper-evident packaging
According to FDA guidelines on Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products, the vast majority of OTC pharma products must be packaged in tamper-resistant packaging.
This means packaging is required to have a barrier of entry or indicator, or have an identifying characteristic, that visibly highlights to the user whether or not the packaging has been opened or compromised.
According to the regulations, manufacturers and packagers can use any packaging system so long as the tamper resistance and evidence standards are met. As it states, product packaging “can reasonably be expected to provide visible evidence to consumers that tampering has occurred” if it is to be FDA-compliant.
The tamper-resistance and evidence guidelines also offer examples of packaging technologies currently available that meet the regulations, including film wrappers, blister or strip packs, bubble packs, heat shrink bands or wrappers, foil, paper or plastic pouches, container mouth inner seals, tape seals and capsule sealing technologies.
Compliant packaging from Origin
Origin is an industry leader in the design and delivery of child-resistant and tamper-evident pharmaceutical packaging products, meeting key regulations and ensuring patient safety.
For more information on medical device regulation in the US – and how this impacts packaging decisions for your products – contact the Origin team today.
*Please note legislation is changing all of the time, and therefore, Origin cannot be held responsible for any of the legal information that is supplied. It is vital that you confirm the comprehensive legal literature with official sources.
