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Serialisation means each package carries a unique identifier, and under the Drug Supply Chain Security Act it is required for prescription drug packages in the US supply chain.

The identifier combines a GTIN, a serial number, the lot and the expiry date, encoded in a 2D DataMatrix barcode. That code needs designed space with an adequate quiet zone and print quality good enough to scan reliably — a genuine constraint on small cartons that should be allocated at layout stage rather than squeezed in at the end.

It is a legal requirement on medicine cartons in the EU and increasingly expected elsewhere.

The product name must appear in raised braille dots on the carton. That has practical consequences for the board specification, because the material must take and hold an embossed dot without cracking or flattening in a stack, and for the layout, because the braille area cannot overlap critical printed content.

The active ingredient's stability data decides it, not preference.

PVC is the baseline with modest moisture barrier. PVC/PVDC coated films step up substantially. Aclar laminates serve genuinely moisture-sensitive actives. Cold-form aluminium gives a near-absolute barrier at the cost of opacity and a larger footprint. Start with the degradation profile — what the molecule needs excluding — and specify backwards from that.

By requiring a cognitive or two-action sequence rather than physical strength.

The 16 CFR 1700.20 protocol tests both populations: children must mostly fail, and adults aged 50–70 must mostly succeed at opening and reclosing. Strength-based closures fail the adult panel. Peel-push blisters dominate in medicines precisely because peeling is a manipulation older adults perform reliably while young children do not.

Look-alike, sound-alike confusion between products in the same family — most often strengths that differ only in a number set identically.

The accepted mitigations are Tall Man lettering, which capitalises the distinguishing letters of confusable drug names, and differentiating strengths by colour and typographic weight rather than by the numeral alone. This is packaging design as error prevention, and it is why pharmaceutical cartons look the way they do.

It is the standard governing packaging for terminally sterilised medical devices, in two parts: materials and system design, and validation of forming and sealing processes.

Where it applies, the package is part of the device — it is the sterile barrier system, and its performance is validated and documented under the same quality system as the product. That has a consequence buyers often miss: packaging changes can be regulatory events requiring notification, so it is not something to value-engineer casually after approval.

Because it is porous enough to admit sterilant gas or steam and then filters microorganisms out afterwards, while being extremely difficult to tear in a way that creates particulate.

That combination is what a sterile barrier needs: permeable during sterilisation, impermeable to microbes afterwards, and clean-tearing at the point of use. Chevron-sealed Tyvek pouches with a peel corner give clinical staff the aseptic presentation they are trained on — peel back, present to the sterile field without contact.

A Supplement Facts panel in the prescribed format, ingredient list, net quantity, manufacturer or distributor contact, and the DSHEA disclaimer alongside any structure-function claim.

Supplements are not FDA pre-approved — under DSHEA the manufacturer is responsible for safety and labelling accuracy and the agency acts afterwards. The most common compliance failure is omitting the disclaimer, which must be present, legible and adjacent to the claim it qualifies.