Use this checklist to confirm that a prescription medicine's labeling meets FDA and EU requirements before release. It covers what the label must contain. For the review process, from locked master to sign-off, use our Artwork Approval Process Checklist alongside it.
This checklist is a working reference for human prescription medicines, not a substitute for the regulations, your marketing authorization, or your own SOPs. For the full requirements, see our Pharmaceutical Labeling Requirements guide.
1. Before You Start
☐ The approved source is identified: the FDA-approved labeling (US) or the approved SmPC, labeling and package leaflet (EU)
☐ You're working from the current approved version, confirmed by its version identifier
☐ All markets, languages, and pack presentations covered by this release are listed
☐ Any national requirements for each EU market have been identified
2. United States (FDA)
Container label and carton
☐ Proprietary name and established name
☐ Strength, dosage form, and quantity
☐ Route of administration where required
☐ "Rx only" statement
☐ NDC, in a format consistent across every label and the prescribing information
☐ Lot number and expiration date☐ Storage conditions
☐ Name and place of business of the manufacturer, packer, or distributor
☐ Any required warnings on the container or carton
Prescribing information
☐ Follows the required format, including the Physician Labeling Rule (PLR) format where it applies
☐ Matches the FDA-approved text exactly
☐ Patient labeling (such as a Medication Guide or Patient Package Insert) is included where required
Barcodes and serialization
☐ Linear barcode containing the NDC is present where required
☐ DSCSA product identifier (2D Data Matrix) is present on each package
☐ Homogeneous cases carry a product identifier
☐ Every barcode decodes to the correct data and matches the human-readable text
3. European Union (EMA and national authorities)
Outer packaging
☐ All required particulars are present (Directive 2001/83/EC, Article 54), including name, strength and form, active substances, excipients with known effect, method and route of administration, warnings, expiry date, storage conditions, marketing authorization holder, authorization number, and batch number
☐ Product name in Braille (Article 56a)
☐ Unique identifier (2D Data Matrix) and anti-tampering device, where required
☐ National "blue box" information included where the Member State requires it
☐ No promotional content on the packaging
Immediate packaging
☐ Blister packs carry at least the minimum particulars (name, marketing authorization holder, expiry date, batch number)
☐ Small immediate packaging carries at least the required minimum particulars
☐ Where there's no outer packaging, the immediate packaging carries the full outer packaging particulars
Package leaflet
☐ Follows the QRD template structure
☐ Matches the approved leaflet text exactly
☐ Reflects readability testing with target patient groups
☐ No promotional content
4. Legibility and Languages
☐ Text is legible, clearly comprehensible, and indelible
☐ Every EU market's version is in its official language or languages
☐ Every language version has been compared against the approved source and against the other versions
☐ Multi-language packs show each language completely and consistently
5. Consistency Across Packaging Levels
☐ Name, strength, batch, and expiry match exactly across immediate packaging, carton, and case
☐ Identifiers (NDC, unique identifier) are consistent across every level
☐ A change to one level has been checked on every other level
See our guide to primary vs secondary pharmaceutical packaging for what each level must carry.
6. Changes and Variations
☐ The change has the right regulatory route: a supplement (US) or a variation or notification (EU)
☐ The change is approved before the updated labeling is released
☐ The updated labeling has been compared against the new approved version, not just the previous draft
☐ Superseded labeling is withdrawn so it can't be used for a reprint
7. Documentation
☐ Every comparison, deviation, and approval is recorded with a timestamp and user
☐ Records are tied to a specific document version
☐ Electronic records and signatures meet 21 CFR Part 11 and EU Annex 11 expectations
☐ The full record can be produced without reconstruction
For more on version control in labeling, see our Document Version Control guide.
Coming Up: Changes to Watch
- 12-digit NDC: FDA's new NDC format takes effect in 2033, and labels will need to move to it consistently. See SPL Is Changing.
- EU Pharma Package: the new EU pharmaceutical legislation will replace Directive 2001/83/EC, change the article references above, and let Member States allow electronic leaflets. See EU Pharma Package: What Changes for Labels and Promotion.
- DSCSA: the small dispenser exemption now runs to November 27, 2027. It doesn't change manufacturers' labeling obligations.
If Your Product Is OTC
OTC medicines follow different rules in a few key areas. In the US, they use the Drug Facts label format and generally require tamper-evident packaging, and DSCSA serialization doesn't apply. In the EU, safety features only apply to specifically listed OTC products. See the OTC section of our packaging guide for details.
If any item above is unchecked, that's the point to resolve before release. The most common gaps aren't missing requirements, but inconsistencies: between language versions, between packaging levels, or between the label and its approved source.
Content Compare verifies every label, carton, and leaflet against its approved source in a single session, including text, graphics, barcodes, and Braille, with a complete audit trail. See how it works on your own artwork.