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Key Facts
- Federal level: Federal law requires notice to the Secretary for certain life-saving drug permanent discontinuances or interruptions likely to cause a meaningful disruption in U.S. supply.
- Federal level: “Meaningful disruption” focuses on production changes that reduce supply by more than negligible amounts and affect the ability to fill orders or meet expected demand.
- Federal level: The statute requires notice at least 6 months before the discontinuance or interruption, or as soon as practicable if that 6-month timing is not possible.
- Federal level: FDA’s non-compliance explanation describes a deadline of “in no case later than 5 business days” after the discontinuance or interruption in manufacturing.
- National overview: State pharmacy and prescribing rules can interact with FDA’s drug-shortage framework, and this varies by state.
- State level: State pharmacy and prescribing rules can differ in how shortage-related information is used, and this varies by state.
- Federal level: FDA distinguishes industry notifications about certain discontinuances and interruptions from public information about existing shortages.
- Federal level: FDA states it cannot require firms to increase production and describes other mechanisms such as reviewing expiration-date extensions based on data and seeking FDA-registered foreign manufacturers in medically necessary situations.
Last reviewed: May 2026. Legal rules, forms, deadlines, and procedures can change by jurisdiction, agency, and court system.
- The federal trigger in 21 U.S.C. § 356c for certain life saving drug disruptions
- Notification timing under the statute and FDA’s “5 business days” noncompliance concept
- How FDA describes reporting roles and channels for drug shortages
- What FDA says it can and cannot do when shortages arise
- Where state law fits alongside the federal notice framework
- Why revisiting the 2012 archive post can still be useful
- Sources
In February 2012, an ABA NOW archive post discussed healthcare reform and drug shortages as among the topics at an ABA conference in San Diego and included an email address for Ira Pilchen.
To understand what that archived conversation foreshadowed, it helps to separate the archive’s historical role from the current controlling federal framework: today, FDA’s handling of certain life-saving drug discontinuances and interruptions runs through 21 U.S.C. § 356c and related FDA drug-shortage program materials.
The federal trigger in 21 U.S.C. § 356c for certain life saving drug disruptions
21 U.S.C. § 356c focuses on a narrow category of events: a permanent discontinuance in manufacturing of the drug, or an interruption of manufacturing, that is likely to lead to a meaningful disruption in the supply of that drug in the United States.
The statute also defines “meaningful disruption” to describe the type of supply risk the notice is meant to address: a production change reasonably likely to reduce supply by more than negligible amounts and that affects the ability of the manufacturer to fill orders or meet expected demand.
Notification timing under the statute and FDA’s “5 business days” noncompliance concept
Federal timing has two connected parts under the statute: notice must be submitted to the Secretary at least 6 months prior to the discontinuance or interruption, or (if that 6-month compliance is not possible) as soon as practicable.
FDA’s explanatory non-compliance page frames the timing as required “in no case later than 5 business days after the discontinuance or interruption in manufacturing,” and it also describes that FDA sends a noncompliance letter to firms that fail to notify as required.
FDA also describes a separate guidance purpose for Section 506C notifications, stating that it is intended to help applicants and manufacturers provide the agency with timely and informative notifications about production changes.
How FDA describes reporting roles and channels for drug shortages
FDA’s Drug Shortages materials describe different reporting channels based on who is providing information and what kind of information is being shared.
Reporting channels comparison (industry vs. public)
| Reporter group | What FDA describes they submit | Channel FDA materials name | What it is (and is not) in the federal notice framework |
|---|---|---|---|
| Drug manufacturers/applicants | Notifications about certain discontinuances, interruptions, and related supply events | CDER NextGen Portal | Manufacturer/applicant notice channel tied to the federal discontinuance/interruption framework |
| Patients, healthcare providers, organizations | Information about the status of an existing shortage | Email status reporting | Status information for existing shortages, separate from manufacturer discontinuance/interruption notice |
| Public-facing signals for new shortages | FDA describes a public portal concept for reporting new shortages | Public portal concept | Public-facing reporting concept, not the statutory manufacturer discontinuance/interruption notice |
FDA’s “How to Report a Shortage or Supply Issue” page states that industry can notify FDA Drug Shortage Staff via the CDER NextGen Portal and that the portal is intended ONLY for drug manufacturers/applicants.
FDA’s Drug Shortages program page describes that patients, healthcare providers, organizations, and other interested parties may submit information about the status of an existing shortage by emailing drugshortages@fda.hhs.gov.
What FDA says it can and cannot do when shortages arise
In FDA’s drug-shortage FAQ, the agency describes limits on its authority by stating that FDA cannot require firms to increase production, while also describing mechanisms it can use depending on the shortage situation.
The FAQ explains that FDA can review expiration-date extensions when the company has data to support an extension, and it also states that when U.S. manufacturers cannot resolve a medically necessary drug shortage immediately, FDA may look for an FDA-registered foreign manufacturer willing and able to redirect foreign-approved product into the U.S. market.
Where state law fits alongside the federal notice framework
State pharmacy and prescribing rules can affect how drug shortages show up in dispensing, substitution, and related workflows, while FDA’s federal shortage notice rules address specific manufacturer discontinuance and interruption notice obligations under 21 U.S.C. § 356c; details vary by state.
Why revisiting the 2012 archive post can still be useful
The 2012 archive item is not current law, but it helps modern readers see why the federal drug-shortage notice framework became a legal and policy focus: when certain discontinuances or interruptions are likely to create a meaningful disruption in supply, 21 U.S.C. § 356c and FDA’s program materials describe defined notification concepts, timing, and reporting roles that shape how FDA receives and responds to those covered supply events.
For another example of how ABA annual-meeting materials can serve as historical context without changing current legal obligations, see ABA annual meeting archive context.
