USA

CountryGuideline nameKeywordsLink
USASafety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Guidance for Industry https://www.fda.gov/media/158522/download
USAPoison Prevention Packaging Act of 1970 Regulationshttps://www.ecfr.gov/current/title-16/chapter-II/subchapter-E
USA§ 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176/subpart-B/section-176.170
USA§ 176.180 Components of paper and paperboard in contact with dry food. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-176/subpart-B/section-176.180
USA§ 175.105 Adhesives. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175/subpart-B/section-175.105
USA§ 175.125 Pressure-sensitive adhesives. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175/subpart-B/section-175.125
USASubpart K – Labeling and Packaging Control § 820.120 Device labeling. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.120
USA§ 820.130 Device packaging. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.130
USAPART 821 – MEDICAL DEVICE TRACKING REQUIREMENTS https://www.ecfr.gov/current/title-21/part-821
USAPART 860 – MEDICAL DEVICE CLASSIFICATION PROCEDURES https://www.ecfr.gov/current/title-21/part-860
USAPART 880 – GENERAL HOSPITAL AND PERSONAL USE DEVICES https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880
USAPART 201 – LABELING https://www.ecfr.gov/current/title-21/part-201
USA§ 820.30 Design controls. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-C/section-820.30
USASubpart C – National Drug CodeNDChttps://www.ecfr.gov/current/title-21/part-207/subpart-C
USACurrent Good Manufacturing Practice Requirements for Combination Productshttps://www.fda.gov/media/90425/download
USASelection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industryhttps://www.fda.gov/media/117883/download
USAInstructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format https://www.fda.gov/media/128446/download
USADrug Supply Chain Security Act (DSCSA)Track and Trace, Serializationhttps://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
USAProduct Identifiers Under the Drug Supply Chain Security Act   Questions and Answers https://www.fda.gov/media/116304/download
USAClassification of Products as Drugs and Devices and Additional Product Classification Issueshttps://www.fda.gov/media/80384/download
USATechnical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Productshttps://www.fda.gov/media/76403/download
USAGlass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4https://www.fda.gov/media/85748/download
USALabeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirementshttps://www.fda.gov/media/71836/download
USAANDA Submissions — Content and Format Guidance for Industryhttps://www.fda.gov/media/128127/download
USAMedical Devices with Sharps Injury Prevention Features – Guidance for Industry and FDA Staffhttps://www.fda.gov/media/71142/download
USANeedlestick Safety and Prevention Acthttps://www.govinfo.gov/content/pkg/BILLS-106hr5178eh/pdf/BILLS-106hr5178eh.pdf
USAApplying Human Factors and Usability Engineering to Medical Deviceshttps://www.fda.gov/media/80481/download
USAMedical Device Use-Safety: Incorporating Human Factors Engineering into Risk Managementhttps://www.qualysinnova.com/download/files/MD-Use-Safety.pdf
USAUse of Recycled Plastics in Food Packaging (Chemistry Considerations) https://www.fda.gov/media/150792/download
USAChild-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry https://www.fda.gov/media/129881/download
USACompounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities https://www.fda.gov/media/102637/download
USACompounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities https://www.fda.gov/media/102615/download
USAMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application https://www.fda.gov/media/90986/download
USARepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities https://www.fda.gov/media/90978/download
USAContainer Closure Systems for Packaging Human Drugs and Biologics   Questions and Answers https://www.fda.gov/media/70794/download
USAContainer Closure Systems for Packaging Human Drugs and Biologics   Chemistry, Manufacturing, and Controls Documentation https://www.fda.gov/media/70788/download
USACPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-450500-tamper-resistant-packaging-requirements-certain-over-counter-human-drug-products
USACPG Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packaging of Over-the-Counter Drug Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-450550-control-and-accountability-labeling-associated-tamper-resistant-packaging-over
USAHydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions https://www.fda.gov/media/160909/download
USALabeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration https://www.fda.gov/media/90473/download  
USAImportation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act https://www.fda.gov/media/142474/download
USAPART 801—LABELING https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
USAGuidance on Medical Device Patient Labeling https://www.fda.gov/media/71030/download
USAUser Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide https://www.fda.gov/media/71135/download
USAA Food Labeling Guide https://www.fda.gov/media/81606/download
USAStandards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages https://www.fda.gov/media/78317/download
USALabeling OTC Human Drug Products (Small Entity Compliance Guide) https://www.fda.gov/media/76481/download
USALabeling OTC Human Drug Products — Questions and Answers https://www.fda.gov/media/72441/download