|
FDA |
ASHP |
|
|
Purpose |
Provides information obtained
from manufacturers about current shortages, estimated duration, and
discontinuations and provides information about FDA’s and other stakeholders’
roles in addressing and preventing shortages |
Notification of new shortages
and status of ongoing shortages; drug shortage management resources |
|
Audience |
Public |
Healthcare practitioners |
|
Scope of Shortage List |
All drugs are listed that are
confirmed to be a national shortage by FDA. A shortage is considered to be
the period of time when the demand for the drug within the United States
exceeds the supply of the drug. Note: A separate shortage
webpage for vaccines and some biologics is maintained by the
Center for Biologics Evaluation and Research. |
All drug and biologic
shortages reported and confirmed with manufacturer that are national in
impact. Note: ASHP frequently lists more shortages than FDA |
|
Source of Shortage Report |
Manufacturers notify FDA of
production disruption and voluntarily provided updates. Reports are also
received from ASHP and from public via drugshortages@cder.fda.gov Note: Manufacturer-provided
information represents shortage status at drug firm level |
Voluntary reports from
practitioners, patients and others |
|
Criteria for Inclusion on List |
Manufacturers cannot meet
current market demand for the drug based on information provided by
manufacturers and market sales research |
(1) Shortage is verified with
manufacturers and (2) affects how pharmacy prepares or dispenses a product,
or (3) requires use of alternative drugs, which may affect patient care |
|
Criteria for Resolving
Shortage |
One or more manufacturers are
in production and able to meet full market demand |
All manufacturers of the drug
restore all formulations and dosage sizes to full availability. Note: Product
are listed despite partial or restricted availability as supply chain
disruptions can result in intermittent shortages at the provider or patient
level |
|
Reason for Shortage |
Provided by manufacturers
using reasons required by legislation. FDA encourages firms to provide
additional information about reasons and other information which, if
proprietary, is nondisclosable without the firms’ permission. |
Provided by manufacturer, if
willing to disclose. Note: May differ from FDA’s due to
different sources of information and legislation requiring FDA to use
specified reasons |
|
Other Information |
Estimated duration, links to
regulatory information such as recalls and Dear Healthcare Provider Letters |
Estimated duration, list of
available products, implications for patient care and safety, shortage
management strategies, therapeutic alternatives |
Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What Are the Differences?
