April 6th 2025
3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.
FDA Issues Draft Packaging Guidance and Pilot Program to Help Secure Supply Chain
January 22nd 2009Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.
Prescription Information Needs to be More Useful
December 29th 2008A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.
FDA Releases Draft Guidance for OTC Labeling
December 18th 2008The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.