Research · 10 min read
A Shortage and a Discontinuation Are Not the Same Thing
One is a condition FDA determines about the whole country. The other is a decision a company makes and reports. They land on the same public list, they read alike at a glance, and only one of them has an agency judgment behind it.
Key takeaways
- A shortage is an FDA determination about national supply; a discontinuation is a company decision that FDA publishes for information.
- Notification duties cover a permanent discontinuance or a meaningful interruption, for the finished drug and for its active ingredient.
- A meaningful disruption is a more than negligible reduction affecting the ability to fill orders, and excludes routine maintenance.
- Notice is due six months ahead, or as soon as practicable, and no later than five business days after the event for a finished drug.
- A missed notification produces an FDA letter, a thirty-day company response, and publication of both within forty-five days.
- Resolved carries an FDA determination; Available reflects the manufacturer's own most current information and does not.
Answer first: different authors, different meanings
A shortage is FDA's determination that demand or projected demand for a drug in the United States exceeds its supply. The agency reaches that conclusion after weighing information from manufacturers, providers, patients and others.
A discontinuation is a company's decision to stop making a product permanently, reported to FDA because federal law requires the report. FDA publishes it, but the underlying call belongs to the manufacturer.
FDA is explicit about the difference in status. It states that the discontinuations listed in its drug shortage database reflect information received from manufacturers and are for informational purposes only.
The two can also cause one another. Discontinuation of the manufacture of a drug is one of the reasons FDA may cite for a shortage, so a company's exit can produce an agency determination weeks or months later.
What a manufacturer is required to tell FDA
The obligation sits in section 506C of the Federal Food, Drug, and Cosmetic Act, and it does not cover every product. It applies to a drug that is life-supporting, life-sustaining, or intended for use in preventing or treating a debilitating disease or condition, including one used in emergency medical care or during surgery.
Within that scope, four events trigger a notification. A permanent discontinuance in the manufacture of the drug. An interruption in its manufacture likely to lead to a meaningful disruption in United States supply. And the same two events for the active pharmaceutical ingredient of that drug.
The notification is not a bare heads-up. It must disclose the reasons for the discontinuance or interruption, and the expected duration of an interruption.
It goes further where the ingredient is implicated. If the active pharmaceutical ingredient is a reason for or a risk factor in the problem, the manufacturer must state the source of that ingredient and any alternative sources it knows of. The same applies to an associated device used to prepare or administer the drug.
FDA also describes how the scope grew. Manufacturers have been required to notify the agency of certain production changes since legislation in 2012, and the notification requirement was expanded by the Coronavirus Aid, Relief, and Economic Security Act in 2020.
What counts as a meaningful disruption
The trigger phrase is defined, which keeps it from being a matter of opinion. A meaningful disruption is a change in production reasonably likely to reduce a manufacturer's supply of a drug by more than a negligible amount. The reduction has to affect the manufacturer's ability to fill orders or meet expected demand.
The definition then carves out the ordinary. It does not include interruptions from matters such as routine maintenance, or insignificant manufacturing changes, so long as the manufacturer expects to resume operations in a short period.
That boundary is why a plant pausing a line is not automatically reportable. The question is whether the pause is expected to bite on the ability to fill orders.
The timing rule, and the deadline underneath it
The default is six months of warning. A notification must reach FDA at least six months before the discontinuance or interruption, or, where that is not possible, as soon as practicable afterward.
FDA states a hard outer limit on the second half of that. For a finished drug or biological product, a notification about a permanent discontinuance or an interruption must be submitted no later than five business days after it occurs.
The reason for the advance notice is operational rather than ceremonial. FDA says the warning gives its drug shortage staff time to work with manufacturers to prevent or mitigate a potential shortage.
The agency describes what it can do with that time. Where it concludes a shortage exists or is likely, it can prioritize and expedite review of an application or supplement that could mitigate the shortage. It can also prioritize and expedite an inspection or reinspection of an establishment that could help.
What happens when a company does not report
The statute builds in a consequence, and it is publication rather than a penalty. Where a manufacturer fails to submit a required notification on time, FDA must issue a letter informing the company of the failure.
The company then has thirty calendar days to respond in writing, setting out the basis for the noncompliance and providing the information it should have submitted.
Within forty-five calendar days of issuing the letter, FDA must make both the letter and any response public on its website, with redactions to protect trade secrets and confidential information.
There are two exits from that publication step. It does not apply where FDA determines the letter was issued in error, or where, after reviewing the response, the agency concludes the company had a reasonable basis for not notifying.
FDA maintains this as a standing public table, listing the drug, the letter and the manufacturer's response, with an archive of older ones. It is one of the few places where a supply-reporting failure is visible to anyone who looks.
The plan behind the scenes
There is one more obligation that never appears on a public list. Manufacturers of a covered drug, of its active pharmaceutical ingredient, or of an associated medical device used to prepare or administer it, must develop, maintain and implement a redundancy risk management plan as appropriate.
The plan has to identify and evaluate risks to the supply of the drug, for each establishment where the drug or its active ingredient is made.
It is not published, but it is not private either. The statute makes a risk management plan subject to inspection and copying by the agency.
The existence of that requirement is the useful part for a reader. Supply resilience is something a manufacturer is expected to have planned for in writing, not merely to react to.
What a company's own supply statement is worth
Company supply announcements are not worthless, and they are not determinations. The difference shows up inside FDA's own database, where both kinds of statement sit side by side.
FDA defines Resolved as its own determination that supply is no longer exceeded by demand or projected demand. It defines Available differently, saying the term reflects the most current information from the manufacturer and is not an FDA determination that the shortage has been resolved.
The agency extends that caution to the fine detail. It states that all of the presentation information posted under individual product shortages is provided by the manufacturer and can change daily.
Read alongside the non-compliance letters, this gives a manufacturer statement a fair weight. It is the best current information from the party that knows most, published by an agency that neither wrote it nor endorsed it.
So a company saying supply has improved is telling you something real about its own capacity and plans. It is not telling you that a shortage has ended, because that is a different sentence written by someone else.
Where the two words behave differently on the list
The retention windows differ. FDA states that resolved shortages remain on the page for six months, while discontinued products remain for one year.
The authority behind them differs, as described above. One entry records an agency conclusion; the other records a company notification.
And the consequences differ. A shortage listing has been the hinge for other rules elsewhere in this area, while a discontinuation entry is published for information.
One thing they share is a limit. Neither word describes your pharmacy. FDA says local supply problems are usually temporary and often involve distribution issues that resolve when the pharmacy can reorder from its distributor.
Reading a supply announcement without over-reading it
Ask who is speaking. An agency determination, a manufacturer statement and a reseller's summary of either are three different documents, and only the first two have a defined meaning.
Ask what is being claimed. Improved capacity, resumed production and a resolved national shortage are separate claims, and a press release may support the first without touching the third.
Ask when. FDA updates the shortage list daily, and manufacturer-supplied detail on it can change daily too, so a status quoted in a marketing page is a snapshot of an unknown date.
And check the primary source before acting on any of it. The database carries the current position, and it takes a search by generic name or active ingredient to read it yourself.
Sources
- 21 U.S.C. 356c — Discontinuance or interruption in the production of life-saving drugsThe scope of covered drugs as life-supporting, life-sustaining or intended for preventing or treating a debilitating disease or condition, including drugs used in emergency medical care or during surgery; the four triggering events covering the finished drug and its active pharmaceutical ingredient; the requirement to disclose reasons, expected duration, the active ingredient source and known alternative sources where the ingredient is a reason or risk factor, and whether an associated device is implicated; the six-month advance timing and the as-soon-as-practicable alternative; the definition of meaningful disruption and its exclusion of routine maintenance and insignificant changes; the non-compliance letter process with its thirty-day response and forty-five-day publication windows, the redaction of trade secret and confidential information, and the two exceptions for a letter issued in error or a reasonable basis; the expedited review and expedited inspection authorities; and the redundancy risk management plan requirement and its subjection to inspection and copying.
- Frequently Asked Questions about Drug ShortagesThe definitions of Resolved, Discontinuation and Available and the statement that discontinuations reflect manufacturer information for informational purposes only; the statement that Available is not an FDA determination that a shortage has been resolved; the statement that presentation information is provided by the manufacturer and can change daily; the six-month and one-year retention windows; the expansion of the notification requirement by 2012 legislation and by the Coronavirus Aid, Relief, and Economic Security Act in 2020; the five-business-day outer deadline for a finished drug or biological product; discontinuation as one of the citable shortage reasons; daily updating of the list; and the note that local supply problems often involve distribution issues that resolve on reorder.
- Drug Shortages: Non-Compliance With Notification RequirementThe restatement of the section 506C requirement and its timing, including the five-business-day outer limit; the statement that the Act requires FDA to send a non-compliance letter to firms that fail to notify; the purpose of advance notification as time for the drug shortage staff to collaborate with manufacturers; and the existence of a standing public table listing the drug, FDA's letter and the manufacturer's response letter, with an archive of earlier letters.
Frequently asked questions
If a drug is discontinued, does that mean it is in shortage?
Not by itself. A discontinuation is a manufacturer's decision to stop making a product permanently, reported to FDA under section 506C and published for information. A shortage is FDA's determination that demand or projected demand in the United States exceeds supply. The two are connected, because discontinuation of the manufacture of a drug is one of the reasons FDA may cite for a shortage. But other companies may still make the same drug, in which case one firm's exit changes very little about national supply.
How much warning does a company have to give before stopping production?
Six months, where that is possible. Federal law requires notification at least six months before a permanent discontinuance or an interruption, or as soon as practicable afterward if six months' notice cannot be given. FDA adds a firm outer limit for the second case. A notification about a finished drug or biological product must be submitted no later than five business days after the discontinuance or interruption occurs. The notification must include the reasons, the expected duration of an interruption, and information about the active ingredient source where the ingredient is implicated.
What happens if a manufacturer misses that notification?
FDA is required to send a non-compliance letter. The company then has thirty calendar days to respond in writing, explaining the basis for the noncompliance and supplying the missing information. Within forty-five calendar days of issuing the letter, FDA must publish both the letter and any response on its website, with redactions protecting trade secrets and confidential information. Publication is skipped only where the agency finds the letter was issued in error, or concludes after reading the response that the company had a reasonable basis for not notifying. FDA keeps a standing public table of these letters.
Should I trust a manufacturer's statement that supply has improved?
Treat it as the best current information from the party closest to the facts, and not as a determination. FDA's own database keeps the two apart. Resolved is defined as an FDA determination that supply is no longer exceeded by demand or projected demand. Available is defined as the most current information from the manufacturer and explicitly not an FDA determination that a shortage has been resolved. FDA also notes that the presentation-level detail on a listing comes from the manufacturer and can change daily.
Does a manufacturer have to plan for supply problems in advance?
Yes, in writing. Manufacturers of a covered drug, of its active pharmaceutical ingredient, or of an associated medical device used to prepare or administer it, must develop, maintain and implement a redundancy risk management plan as appropriate. The plan identifies and evaluates risks to the supply of the drug for each establishment where the drug or its active ingredient is manufactured. The plan is not published, but the statute makes it subject to inspection and copying by the agency.