In March, the Food and Drug Administration (FDA) announced a drastic downturn in the nation’s supply of Albuterol Sulfate 0.5% inhalation solution due to issues with the manufacturers. To return stability to the market, Ritedose Corp.’s 503B outsourcing facility will be distributing Albuterol 0.5% in blow-fill-seal (BFS) containers by early May.
Albuterol Sulfate, which is used with a nebulizer as a breathing treatment for asthma and certain types of chronic obstructive pulmonary disease, is considered an essential medication by the FDA. With an annual demand of nearly 20 million doses per year, the solution was being produced in two dosage forms: Akorn Inc. produced 300,000 glass bottles annually, while Nephron produced 20 million BFS vials annually. Both were in 0.5 milliliter fill volume. Akorn has since declared bankruptcy, and Nephron has been cited by FDA for cross-contamination of drug product and failure to follow up with an adequate investigation.
While products produced through the 503B manufacturing process are prohibited from being sold and distributed via wholesalers, Ritedose will compound the 5mg/ml concentration of Albuterol Sulfate and distribute it exclusively to healthcare facilities until the FDA deems the shortage is no longer in effect.
Ritedose worked with several of the large hospital systems in the nation to accelerate development from a typical six-month timeframe to a record timeline of only four months as the need for quality supply outpaced the desire for a longer shelf life. The shelf life is determined based on real-time stability testing, meaning that if six months of shelf life is required then the product would need to be tested under the proposed storage conditions for six months. Ritedose will launch the product with 60 days of beyond-use dating (BUD), extending the BUD as additional real-time stability data comes in and the product passes all stability testing requirements.
For long-term supply chain continuity, Ritedose will submit an additional abbreviated new drug application (ANDA) in other BFS container sizes in the second half of 2023.