La réglementation en vigueur aux États-Unis en matière de produits pharmaceutiques

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.

As such, it’s important for any pharmaceutical or pharma packaging companies to understand the regulations out there that they have to abide by. This includes essential safety features such as child resistant and tamper evidence, as well as which materials can and cannot be used in pharma packaging.

Here, we’re going to break down the FDA guidelines for regulations around pharma packaging in the US.

What packaging needs child resistance?

The Poison Prevention Packaging Act was signed into law in 1970, as a means to protect children from accessing and taking potentially dangerous substances in the household, such as food products, cosmetics, and pharmaceuticals. As such, pharma packaging must follow regulations regarding child-resistant design.

Different products can make use of different design features and approaches to ensure that products are child resistant. This includes using safety caps to prevent children from opening pharma products as well as using single-dose blister packaging, such as peel-push blisters.

Examples of products that are available over-the-counter and require child-resistant packaging includes the following:

  • Acetaminophen
  • Aspirin
  • Ibuprofen
  • Imidazolines
  • Mouthwash
  • OTC switch drugs
  • Naproxen
  • Methyl salicylate
  • Iron-containing drugs and dietary supplements
  • Diphenhydramine

A more complete list of substances requiring child resistance can be found in 16 CFR §1700.14, the “Substances requiring special packaging” section of the Poison Prevention Packaging Act of 1970 Regulations. Furthermore, the section 1700.15, “poison prevention packaging standards” includes a full overview of necessary performance specifications for packaging to be consider 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.

Since then, information on whether packaging is child-resistant or not is supposed to be added to the labels, since health care professionals and patients are not able to tell whether it is or not.

What packaging requires tamper evidence?

According to the 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 that the 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 by tampering attempts. In all applicable cases except with ammonal inhalant in crushable glass ampoules, aerosol products, or containers of compressed medical oxygen, the packaging must also have labels that indicate to the consumer which tamper-resistant features are used.

The regulations outline that all OTC human products, cosmetic liquid oral hygiene products and vaginal products, and contact lens solutions and tablets used to make those solutions require tamper-resistant packaging and tamper evidence. The only named exceptions to these regulations are the following:

  • Dermatologics
  • Dentifrices
  • Insulin
  • Throat lozenges

According the regulations, manufacturers and packagers can use any packaging system so long as the tamper resistance and evidence standards are met. As it states, the products packaging “can reasonably be expected to provide visible evidence to consumers that tampering has occurred” if it is to FDA compliant.

The tamper resistance and evidence guidelines also offer examples on packaging technologies currently available that meet the regulations as they stand, 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, capsule sealing technologies, an