Stay updated and compliant with these critical FDA resources:
This detailed guide covers everything from prescription drug labeling to barcode standards, ensuring your products meet all safety and regulatory requirements:
1. FDA Label Search - An essential tool for checking the latest labeling information to ensure compliance.
- [Access FDA Label Search] (https://labels.fda.gov/)
2. 21 CFR Part 201 - Prescription Drug Labeling- Outlines detailed requirements for prescription drug labeling to ensure accuracy and prevent misleading information.
- [21 CFR Part 201 Regulations] (https://www.ecfr.gov/..)
3. 21 CFR Part 314 - New Drug Applications - Essential for understanding the FDA approval process for new pharmaceuticals.
- [21 CFR Part 314 Overview](https://www.ecfr.gov/..)
4. 21 CFR Part 610 - General Biological Products Standards- Standards that govern the labeling of biological products, ensuring quality and safety.
- [21 CFR Part 610 Standards] (https://www.ecfr.gov/..)
5. FDA Guidance on Labeling of Human Prescription Drugs and Biological Products- Provides detailed guidance on implementing content and format requirements under the Physician Labeling Rule (PLR).
- [Labeling of Human Prescription Drugs and Biological Products] (https://www.fda.gov/..)
6. OTC Drug Facts Label - Guidelines to ensure clear and accessible labeling for over-the-counter medications.
- [OTC Drug Facts Label] (https://www.fda.gov/..)
- [Further Information on OTC Labels] (https://www.fda.gov/..)
7. CFR Section 201.66 - Specifies content and format requirements for labeling of human prescription drug and biological products.
- [CFR Section 201.66 Details] (https://www.accessdata.fda.gov/..)
8. Barcode Label Requirements- Ensures barcodes on pharmaceutical products are properly formatted for tracking and safety.
- [FDA Barcode Label Requirements] (https://www.federalregister.gov/..)
This guide is intended to provide pharmaceutical professionals with quick and easy access to the most relevant FDA guidelines, helping to ensure that your labeling and barcoding practices are compliant and contribute to the overall safety and efficacy of your products.
Read also:
