Custom Pharmaceutical Packaging: Compliance, Child-Resistant & Clinical Formats (2026)
Pharma Packaging Has Zero Tolerance for Error
Pharmaceutical packaging is the most regulated packaging category in the US. FDA 21 CFR Part 211 mandates cGMP compliance for every component that contacts or contains a drug product. ASTM D3475 governs child-resistance. USP standards cover moisture and oxygen barrier requirements.
Pharmaceutical Packaging Formats
1. Folding Cartons for Prescription & OTC
Folding cartons are the primary package for prescription and OTC medications. Printed with Drug Facts panel, NDC number, lot/expiry, and tamper-evident features.
- Material: 18-24pt SBS, FDA-compliant inks
- Cost: $0.40-$1.50/unit at 5K
2. Child-Resistant Packaging
ASTM D3475 certified packaging for Schedule II-V medications. Push-through blister packs, CR bottle caps, and CR cartons.
- Cost: $0.60-$2.50/unit at 5K
3. Clinical Trial Packaging
Custom kits for clinical trials with blinding labels, patient ID tracking, and temperature-sensitive indicators.
- Cost: Custom quote based on study protocol
Frequently Asked Questions
What FDA requirements apply to pharma packaging?
21 CFR Part 211 for cGMP compliance, 21 CFR Part 201 for labeling (Drug Facts panel, NDC, lot/exp), ASTM D3475 for child-resistance on Schedule II-V medications, and USP <671> for container specifications. We maintain FDA compliance documentation on all pharmaceutical packaging formats.
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