Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. What do you want the final dosage form to do? What formulation and process approach are you going to use? What traps and roadblocks might you encounter? Understanding the options and their ramifications is the first step toward devising a plan.
When the Drug Supply Chain Security Act (DSCSA) was passed, it laid out requirements for manufacturers regarding transaction documentation, procedures for suspect product investigations, authorized trading partners and the use of a unique unit-level product identifier – a serial number – for each package and homogenous case of prescription drugs.
The FDA has postponed enforcement until November 2018, granting manufacturers one more year to complete implementation of a serialization program.
Are you serialization-ready? Failure to comply could result in penalties and the inability to sell your un-serialized products.