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The Future of Repackaged Avastin

Posted on 04/21/15

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Avastin® (bevacizumab) is a medication used off-label by ophthalmologists to treat eye diseases such as macular degeneration and diabetic retinopathy.  I estimate hundreds of thousands of doses of Avastin are administered annually in the U.S. alone. 

Avastin is repackaged by pharmacists to facilitate the administration of an expensive drug by an ophthalmologist to multiple patients in a cost-efficient manner.  The cost of the drug is a major justification for repackaging this agent.  The average price often quoted for a dose of ophthalmic Avastin is $50.  This compares quite favorably to other medications used for similar conditions; $1,950 for a dose of Lucentis® (ranibizumab) or $1,850 for a dose of Eylea® (aflibercept).  Several insurance companies require a patient to have been treated with Avastin before a more expensive therapy will be covered for the patient. 

In February, the FDA published Draft Guidance for Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application that stipulates repackaged Avastin be assigned a 4-hour Beyond Use Date (BUD).  The 4-hour BUD may be extended to 24 hours if a microbial challenge study is conducted and shows that “microbial growth will not progress to unacceptable levels within the period of the BUD.” 

The FDA asserts in the Draft Guidance that repackaging Avastin is manufacturing, not compounding: “For purposes of this guidance, repackaging means taking a licensed biological product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the product.”   

The FDA Draft Guidance allows a comment period of 90 days that will conclude in mid-April.  The FDA will consider the comments that are submitted and a final Guidance document will be published. 

It is my belief that most pharmacists have considered repackaging injectable medications to be a pharmacy compounding function, using USP <797> standards as the guide.  This Draft Guidance, as well as the Draft Guidance on Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities, will have a major impact on pharmacy practice due to the strict BUDs that are imposed. 

The FDA is justifiably concerned about safety and quality.  There are many competing interests to consider related to repackaging drugs and biologicals. If these draft guidance documents become final, I am very concerned the cost of healthcare will skyrocket even faster, patients will be undertreated or untreated, and the drug companies will sell more of their preferred (i.e. expensive) drugs. 

Disclaimer:  The opinions expressed below belong to Bill Mixon, RPh, MS, FIACP, FACA.  He is not speaking for any organization with which he may be affiliated.  This is not legal advice. 

Topics: Sterile Compounding

About the Author

Bill Mixon RPh, MS, FIACP, FACA, is the owner of The Compounding Pharmacy in Hickory, North Carolina. He received his BS degree from the Medical University of South Carolina in 1977, and his MS degree from UNC in 1983. He has completed two hospital pharmacy residencies, has been a Certified Diabetes Educator and a Certified Geriatric Pharmacist. Mr. Mixon is a fellow of the International Academy of Compounding Pharmacists, and his pharmacy is one of about 170 nationwide that is accredited by the Pharmacy Compounding Accreditation Board. Mr. Mixon serves on the USP Expert Committee for Compounding. He was elected to the NC Board of Pharmacy in May of 2011, and is the Board representative of the Pharmacy Compounding Work Group that is tasked with revising the rules for compounding in North Carolina, and was recently appointed to the FDA Pharmacy Compounding Advisory Committee as the Industry representative. Mr. Mixon’s professional memberships include NCAP, APhA, NCPA, NABP, and ACVP. Mr. Mixon is the pharmacist member of the Catawba County Board of Health. His 35 years of experience in hospital and community pharmacy, long-term care, and hospice care have prepared him to serve the pharmacists of North Carolina. His broad practice experience gives him insight into a very diverse group of practice settings, as well as many of the issues facing pharmacists today.