Drug Shortage Assistance
How might compounding help with drug shortages?
According to the U.S. Food and Drug Administration (FDA), a compounding pharmacy is allowed to compound a human or veterinary pharmaceutical that is on temporary back-order or that is manufacturer discontinued. Such a pharmacy cannot, however, compound a prescription or over-the-counter drug or use any ingredients that have been removed from the marketplace due to safety reasons. Before approaching a compounding pharmacy to ask if they can compound an unavailable pharmaceutical, ask yourself this question: Is the pharmaceutical I seek FDA approved? If so, the compounder might be able to help you by prescription.
Lots of factors contribute to drug shortages, and compounding pharmacies may be able to help provide drug shortage assistance when one or more of these challenges are halting pharmaceutical manufacturing.
- bulk or raw material supply shortage
- production delay or halt due to regulatory infraction uncovered during FDA inspection
- manufacturer’s voluntary recall because of contamination, etc.
- manufacturer or formulation change prompting production delay
- business decision to postpone or cease production because generics are available, patents are expiring, and/or market size is changing [Other factors: drug approval status, regulatory compliance requirements, anticipated clinical demand, and/or reallocation of resources to other products. Note that FDA cannot demand continued production of medically necessary products.]
- manufacturer mergers that narrow product lines, prompt discontinuations, and/or shift production to new facilities, meaning manufacturing delays
- less-than-desirable inventory management practices such as stockpiling prior to price increases and hoarding prompted by rumors of an impending shortage
- unanticipated demand spikes arising from new indications, new therapeutic guidelines, or disease outbreaks
- natural disasters that impact manufacturing facilities or prompt heightened demand to treat disaster victims
If your compounding pharmacy can procure the ingredients and formulation (i.e., “recipe”) for your back-ordered or manufacturer discontinued pharmaceutical of choice, their drug shortage assistance may be able to help you get through the shortage by prescription order.