As you may be aware, recently, draft FDA guidance documents were released that provide the framework for how the agency intends on enforcing the Drug Quality and Securities Act (DQSA).
Addressed in these documents was the repackaging of certain human drugs. Of particular concern is the agency’s intended limitations on repackaging biological products, such as Avastin®, outside the scope of an approved biologics license application (BLA).
These guidance documents will greatly affect your ability to utilize Avastin® in prefilled syringes, thus impacting your patient’s access to affordable treatment. Chiefly, the documents seek to limit expiration dating on repackaged Avastin® syringes to 24 hours when produced at a traditional 503A compounding pharmacy (patient specific) and to 5 days when produced at an FDA registered 503B outsourcing facility (non-patient specific). This limitation comes in spite of published literature supporting more extended dating, and our facility having conducted a stability study validating the prefilled syringes to be stable at 90 days.
Pine Pharmaceuticals is committed to navigating this obstacle as efficiently as possible to ensure your continued access to repackaged Avastin®. However, as you are aware, these expiration dating limitations will impose a challenging burden on your practice and its use of Avastin® when considering shipping times, logistics of inventory, etc.
Currently, these draft documents are out for a 90 day public comment period. Time is of the essence and it is essential that we all voice our opinion to ensure that you continue to have reasonable access to repackaged Avastin® to treat your patients.
Please consider contacting your colleagues, local representatives, and medical group affiliations and societies. We all must voice our opinion to urge the FDA to reconsider segregating aseptically manipulated biologics under an unreasonable and unnecessary set of guidelines. Time is of the essence, and we cannot stress enough the importance of your voice being heard.
As always, please feel free to contact us to address your questions and concerns.
Alfonse Muto, RPh, President
To submit comments to FDA
View a copy of the DRAFT Guidance