The role of outsourcing facilities in overcoming drug shortages.
Level 4 - case-series / case-control
Cross-sectional comparison of FDA drug shortage databases and 503B compounding reports (by design analogy, not clinical CEBM)
PubMed 32943335 · doi:10.1016/j.japh.2020.08.027
What was done
The authors compared all current and resolved FDA-reported drug shortages through January 27, 2020, against 503B product reports submitted to the FDA by outsourcing facilities between July 2018 and June 2019. They assessed the active pharmaceutical ingredient (API) and dosage form for each product on shortage to determine the proportion compounded by 503B outsourcing facilities.
What was found
There were 344 unique APIs on the FDA drug shortage list and 774 unique APIs on the 503B product reports. Of the shortage APIs, 27% (74 of 272) appeared on both lists, and 18% (50 of 272) were compounded by outsourcing facilities in the same dosage form as what was on shortage.
Why it matters
Although 503B outsourcing facilities are legally positioned to compound medications at scale during drug shortages, minimal overlap exists between shortage lists and actively compounded products.
Limits
The study is descriptive and cross-sectional without measuring compounding volume, facility capacity, or clinical access outcomes. There was a temporal misalignment between shortage tracking (through January 2020) and 503B report windows (July 2018 to June 2019), and reasons for lack of compounding were not evaluated.
Cited by
- supports Under FDA compounding rules, compounded medications can be prepared either during an official shortage or to meet a unique clinical need of an individual patient.