The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.
Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.
The new year is just around the corner, signaling a fresh start and new beginning. Janus, the Roman god of new beginnings and namesake of the month of January, likely inspired our familiar tradition of reflection and resolution this time of year. Janus had two faces, which allowed him to look backward to the past and forward to the future.