Manufacturers Affected By SPL

The FDA’s initial mandate regarding Structured Product Labeling (SPL) was instituted in 2005 with Human Health prescription drugs. Since that time, many other manufacturers of drugs have been required to convert and submit their drug labels in the SPL format. Below is a brief listing of the affected Life Sciences manufacturers that Reed Tech supports with its SPL Conversion, Lifecycle Management, and SPL XML Publishing Solutions:

• Active Pharmaceutical Ingredients (APIs) - Required as of June 1, 2009
• Animal Health - Required as of June 1, 2009
• Biologics and Vaccines - Required as of October 15, 2009
• Cosmetics - Required as of June 1, 2009
• Homeopathics - Required as of June 1, 2009
• Medical Devices - Proposed Rule anticipated in 2012
  • The Medical Device mandate is expected to include Unique Device Identifier (UDI) Registration, with the possibility of Device Establishment Registration and Device Labeling and Listings required in the future. The Center for Devices and Radiological Health (CDRH), indicates that Medical Devices and Medical Device/Drug Combination Products will be affected by the proposed mandate. The FDA may begin this process with a Content of Labeling Pilot for Home Use Medical Devices.
• Medical Gases - Required as of June 1, 2009
• Over-the Counter (OTC) Drugs - Required as of June 2, 2008
• Prescription (Human Health): Branded and Generic - Required as of October 31, 2005