MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 1 of 24

POLICY AND PROCEDURES

OFFICE OF THE CENTER DIRECTOR

Drug Shortage Management

Table of Contents

PURPOSE..............................................................................1

BACKGROUND ...................................................................2

POLICY.................................................................................3

RESPONSIBILITIES...........................................................3

PROCEDURES.....................................................................9

EFFECTIVE DATE............................................................15

CHANGE CONTROL TABLE..........................................15

ATTACHMENT 1: Drug Shortage Process Flowchart.....17

ATTACHMENT 2: Medical Necessity Determination 

Form...................................................................................18

ATTACHMENT 3: Office of Compliance Drug 

Shortage Consult Form ......................................................19

ATTACHMENT 4: Shortage Information Summary 

Form for Requests Initiated by the CDER Drug 

Shortage Staff.....................................................................21

ATTACHMENT 5: Index of Acronyms............................24

PURPOSE

This MAPP establishes CDER’s policy and procedures for notification, evaluation, and 

management of drug1 shortage situations for all CDER products including those 

marketed under new drug applications (NDAs), biologics license applications (BLAs), 

abbreviated new drug applications (ANDAs), and unapproved drugs marketed without an 

approved application.

This MAPP also outlines the responsibilities of the CDER Drug Shortage Staff (DSS).

 1 Refers to all drug and biological products regulated by CDER.
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 2 of 24

This MAPP does not establish procedures for interactions between CDER and other FDA 

centers or offices outside of CDER, with the exception of FDA’s Office of Regulatory 

Affairs (ORA). 

BACKGROUND 

• In 1999, the need to expand and enhance the management of shortage situations 

across the Center resulted in the formal establishment of the DSS. The DSS serves as 

CDER’s focal point for the evaluation and management of drug shortages. Through 

communication, facilitation, and negotiation, the DSS works with internal and 

external stakeholders to prevent, alleviate, and resolve shortages, in support of FDA’s 

mission.

• On October 31, 2011, the President of the United States signed Executive Order 

13588, Reducing Prescription Drug Shortages. This Executive Order highlighted the

serious public health threat of drug shortages and directed the FDA to take steps to

further “help to prevent and reduce current and future disruptions in the supply of life

saving medicines.”

• On December 19, 2011, FDA published an interim final rule (IFR) in the Federal 

Register amending its postmarketing reporting regulations implementing certain 

provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require 

manufacturers who are the sole manufacturers of certain drug products to notify FDA 

at least six months before discontinuance of manufacture of the products. This interim 

final rule modifies the term “discontinuance” and clarifies the term “sole 

manufacturer” with respect to notification of discontinuance requirements. The 

broader reporting resulting from these changes enables FDA to improve its collection 

and distribution of drug shortage information to physician and patient organizations 

and to work with manufacturers and other stakeholders to respond to potential drug 

shortages.

• On July 9, 2012, the Food and Drug Administration Safety and Innovation Act 

(FDASIA) was signed into law. Title X of FDASIA included new drug shortages 

provisions. The new provisions require FDA to submit to Congress an annual report 

on drug shortages and FDA’s efforts to address them. In accordance with section 

506C of the FD&C Act, implemented by 21 CFR 314.81(b)(3)(iii) and 21 CFR 

600.82(a), manufacturers must report all permanent discontinuances of and all 

interruptions of the manufacture of any drug that is life supporting, life sustaining, or 

intended for use in the prevention or treatment of a debilitating disease or condition, 

including any such drug product used in emergency medical care or during surgery 

(excluding radiopharmaceutical products), which are likely to lead to a meaningful 

disruption in the supply of that drug in the United States.

• On February 12, 2013, FDA issued a Federal Register Notice (Vol. 78, No. 29)

requesting comments related to drafting a strategic plan on drug shortages.

• On October 31, 2013, FDA issued its Strategic Plan for Preventing and Mitigating 

Drug Shortages. The plan explains the root causes of drug shortages, FDA’s 
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 3 of 24

procedures for helping to prevent or mitigate shortages, and FDA’s strategy for 

strengthening those procedures. The plan outlined recommended stakeholder actions

to help prevent or mitigate shortages. 

• On October 31, 2013, FDA issued a proposed rule, Permanent Discontinuance or

Interruption in Manufacturing of Certain Drug or Biological Products, which 

proposed to implement certain sections of the FD&C Act as amended by FDASIA. 

On July 8, 2015, FDA published the final rule, which became effective on September 

8, 2015. 

POLICY

• The CDER Deputy Director for Regulatory Programs serves as the Drug Shortage 

Coordinator for the DSS. The DSS resides in the CDER Office of the Center Director, 

Immediate Office.

• The DSS establishes and maintains a network of designated contacts within CDER to 

address drug availability issues comprehensively and proactively. 

• The DSS monitors drug supply and demand, including those used as medical 

countermeasures (MCMs), to ensure availability for emergency situations. 

• The DSS serves as a liaison to private industry, other FDA centers, and other 

government organizations, including but not limited to the Centers for Disease 

Control and Prevention (CDC) and the Department of Defense (DoD).

• The DSS receives and evaluates information regarding potential or actual drug 

shortages from additional sources, such as the American Society of Health-System 

Pharmacists (ASHP) and other external entities, including health care professionals 

and patients.

• When the DSS confirms a drug shortage exists, the DSS posts this information on the 

Drug Shortage Website. 

RESPONSIBILITIES

The DSS Drug Shortage Coordinator will:

• Supervise the DSS activities.

• Provide guidance on policy issues related to shortages. 

• Provide guidance on shortage management.
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The DSS will (see Attachment 1 and the Procedures section for detailed procedures): 

• Receive reports from all sources (including industry, other FDA offices, the ASHP

and other external entities, health care professionals, and patients) related to drug 

shortages and discontinuations. A manufacturer must provide notice at least 6 months 

in advance, or as soon as practicable, but in no case later than five business days after 

the permanent discontinuance or interruption in manufacturing occurs. If applicable, 

shortages and discontinuances also should be reported to the review office or division 

that regulates the application. 

• Verify that a shortage or discontinuation exists through communications with 

manufacturers, other FDA offices, and external entities such as the ASHP, and 

through the use of market research data.

• Search the drug shortage database and other available databases for drug history,

information on other drugs in the same class, related CDER Office of Compliance 

(OC) activity, any existing medical necessity determination, and status as a critical, 

emergency, or MCM drug.

• Request a new or updated Medical Necessity Determination Form from the Office of 

New Drugs’ (OND) clinical division with expertise on that drug product.

• Work with CDER offices and staff with defined drug shortage management 

responsibilities, other FDA offices, industry, and outside entities to share information 

on a drug shortage, including the medical necessity of the drug, to develop a risk 

versus benefit profile for impacted products and a drug shortage management plan.

• Identify, review related information, and monitor the supply of products from 

alternate sources related to drug shortages, when necessary.

• After verififying the shortage, post shortage issues and discontinuation information

provided by firms on CDER’s Drug Shortage Website. 

• Monitor each drug shortage situation from first report to resolution. 

• Communicate information in a timely manner to the appropriate stakeholders both 

within and outside of the Agency.

• Include CDER stakeholders and stakeholders from other centers in discussions with 

industry related to drug shortage situations, as appropriate.

2

• Ensure the CDER Drug Shortage Website contains an up-to-date list of drugs that are 

determined to be in shortage. Information on this Website includes current drug 

shortages, resolved situations, and discontinuances.

• Manage and update information on current shortages, pending issues, resolved 

shortages, averted shortages, and information requests in the drug shortage database. 

 2 CDER’s OC or Office of Pharmaceutical Quality (OPQ) or both should be included in discussions with 

industry that have Current Good Manufacturing Practices (CGMP) issues, drug quality issues, or other 

manufacturing issues related to drug shortages.
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

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• Maintain the DSS email account (drugshortages@fda.hhs.gov) listed on the CDER 

Drug Shortage Website. Respond to drug shortage inquiries received through the DSS 

email account or by phone to 240-402-7770.

• Submit the Annual Report on Drug Shortages, which includes FDA’s efforts to 

address shortages, to Congress.

• Notify CDER’s Counter-Terrorism and Emergency Coordination Staff (CTECS) of 

issues relating to possible shortages or supply problems of any MCM drugs.

• Provide CDER’s Office of Communications (OCOMM) with materials, as 

appropriate. 

CDER OND will:

• Provide staff to work with the DSS when drug shortages are for innovator products

without a generic product, or there is not enough generic product available to meet 

demand. The appropriate OND Office Directors, Division Directors, Team Leaders, 

Medical Officers, and Project Managers will assist in the assessment of the shortage, 

in particular, the clinical implicaitons of the shortage.

• Complete the Medical Necessity Determination Form when requested by the DSS, 

btain the necessary clearance, and return the form to the DSS. 

CDER Office of Pharmaceutical Quality (OPQ) will: 

• Facilitate prevention, mitigation, and resolution of drug shortage situations that 

involve drug quality (i.e., chemistry, manufacturing, and controls (CMC)) related 

issues. Quality disciplines include, but are not limited to, drug substance, drug 

product, microbiology, biopharmaceutics, and manufacturing sites regarding nonenforcement-related issues.

• Participate in regulatory and compliance discussions with industry that involve an 

actual or likely drug shortage that is related to drug quality, including facility issues.

• Immediately forward all notifications of a drug shortage or potential drug shortage 

received by OPQ staff to the OPQ Drug Shortage Coordinator (OPQ DSC).

• Appoint an OPQ DSC and any additional points of contact within OPQ sub-offices to 

act as liaisons between OPQ staff and the OPQ DSC.

OPQ Drug Shortage Coordinator (DSC) will:

• Act as liaison and provide guidance and expertise to OPQ management and staff, the 

DSS, and other CDER offices for drug shortage matters related to drug quality,

including facility issues.
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• Coordinate with OPQ sub-offices regarding quality, including facility issues, if the 

shortage involves more than one OPQ office.

• Immediately forward all notifications of a drug shortage or potential drug shortage to 

the DSS and, as appropriate, to the Office of Generic Drugs (OGD) Drug Shortage 

Coordinator (OGD DSC). 

• Obtain confirmation from the DSS that the drug is in shortage, or there is likely to be 

a shortage, before expediting the review of a supplement in response to an applicant’s

request claiming drug shortage-related reasons.

• Coordinate with the DSS for an NDA, BLA, ANDA,or supplement to an NDA or 

BLA to prevent, mitigate, or resolve a drug shortage.

o When there is a need to expedite the quality review of an application or 

supplement to prevent, mitigate, or resolve a drug shortage.

o Before taking a complete response action on a manufacturing supplement 

to determine if the action could cause or exacerbate a drug shortage.

o If an active pharmaceutical ingredient (API) supplier has a discontinuance 

or interruption to determine whether any drug products that use the API 

supplier are in shortage or likely to be in shortage.

• Coordinate with DSS, OGD DSC, OC, and ORA, as appropriate, when there is a need 

to expedite the review of a manufacturing supplement, for which an inspection is 

needed, to prevent, mitigate, or resolve a drug shortage.

• Coordinate with the DSS, OGD DSC, OC, and ORA, as appropriate, on a 

manufacturing site with compliance-related issues to determine if any of the drugs 

manufactured at the site are in shortage or are likely to be in shortage.

• Provide required data elements to the DSS for submission of the Annual Report on 

Drug Shortages that is submitted to Congress.

CDER Office of Compliance (OC) will:

• Assign a point of contact from the Recall and Shortages Branch (RSB) in OC, Office 

of Drug Security, Integrity, and Recalls to coordinate OC program actions for 

managing a shortage.

• Participate in any compliance and regulatory discussions when compliance actions, 

recalls, or drug withdrawals are under discussion and involve an actual or potential 

drug shortage.

• Consult (see Attachment 3) with the DSS, through the RSB, before any enforcement 

action or issuance of a warning letter to determine if the action or letter could cause or 

exacerbate a shortage. If it is determined an action or warning letter could lead to or 
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

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exacerbate a shortage, OC will work with the DSS and other appropriate offices to 

evaluate the risks to patients. Such consults are requested through the RSB.

• When appropriate, evaluate the need for distribution of drug products that would 

otherwise violate the FD&C Act and consider exercising enforcement discretion.

• Evaluate proposed actions from a manufacturer to help prevent, mitigate, or resolve a 

drug shortage. 

• Help identify alternate drug sources for drugs in shortage, as needed.

• Provide registration and listing guidance to firms providing alternate sources of drugs 

to alleviate a shortage.

• Inform FDA’s ORA regarding drugs in shortage. 

• Facilitate the U.S. entry process for drugs in shortage, as needed.

• Collaborate with ORA and develop options required to facilitate expedited 

inspections. 

CDER Office of Generic Drugs (OGD) will:

• Facilitate prevention, mitigation, and resolution of regulatory and scientific issues for

drug shortages related to a generic drug and for drug shortages related to situations 

where availability of a generic drug could address shortage related issues.

• Immediately forward all notifications of a drug shortage or potential drug shortage to 

the OGD DSC.

• Participate in any regulatory and compliance discussions with industry that involve an 

actual or likely drug shortage that is related to a generic drug.

• Appoint an OGD DSC.

OGD Drug shortage Coordinator (DSC) will: 

• Act as liaison and provide guidance and expertise to OGD management and staff, the

DSS, and other CDER offices on drug shortages related to generic drugs; provide 

advice on how generic drugs currently available can address the shortage; and provide 

advice on and expedite ANDAs that are currently under review and may resolve a 

drug shortage.

• Notify the DSS when a medical necessity determination for a generic drug is needed.

• Coordinate with the DSS and the OPQ DSC, as appropriate, when there is a need to 

expedite an ANDA or a supplement to an ANDA to prevent, mitigate, or resolve a 

drug shortage.

• Immediately forward all notifications of a drug shortage or potential drug shortage to 

the appropriate OGD Regulatory Project Manager (RPM), the DSS, and as 

appropriate, the OPQ DSC.
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

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• In collaboration with the DSS, and, as needed, the OPQ DSC, participate in any 

regulatory and compliance discussions that involve an actual or potential shortage

that is related to a generic drug.

• Apprise the DSS of all ANDA approvals and discontinuances of drugs in shortage.

• Serve as the liaison to generic drug applicants and, in coordination with the OPQ 

DSC, with generic drug manufacturers for drug shortage issues.

• Provide required data elements to the DSS for the Annual Report on Drug Shortages 

that is submitted to Congress.

• With respect to pending ANDA applications related to a drug shortage, ensure that 

review of all pending applications and supplemental applications has been 

appropriately prioritized in accordance with OGD’s MAPP regarding Prioritization of 

the Review of Original ANDAs, Amendments, and Supplements (MAPP 5240.3).

CDER Office of Communications (OCOMM) Director will:

• Appoint coordinators within OCOMM’s Division of Online Communications (DOC) 

and Division of Drug Information (DDI) to work with the DSS.

CDER OCOMM will: 

• Provide assistance to the DSS by responding to inquiries regarding known drug 

shortage issues.

• Forward new drug shortage inquiries and notifications received by DDI to the DSS.

• Assist with development and dissemination of information regarding shortages.

OCOMM Division of Drug Information (DDI) Coordinator will: 

• Collaborate with the DSS to handle shortage reports received by DDI.

OCOMM Division of Online Communications (DOC) Coordinator will: 

• Collaborate with the DSS to post drug shortage information on the FDA Website.

CDER Counter-Terrorism and Emergency Coordination Staff (CTECS) will:

• Work with the DSS on issues related to the Strategic National Stockpile (SNS) and 

emergency preparedness and response activities.

• Serve as CDER’s principal liaison with the SNS and other strategic emergency 

stockpiles.

• Notify the DSS of issues relating to possible shortages or supply problems of any 

MCM drugs.

• Collaborate with the DSS when shortages of CDER-regulated products may be 

anticipated during incidents coordinated by CTECS.
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CDER Office of Executive Programs (OEP) will:

• Report important drug shortage and discontinuance information to the Center 

Director, CDER, and the Office of the Commissioner.

• Consult with the DSS and obtain clearance on press releases and internal background 

documents and talking points relating to shortages.

• Obtain clearance on correspondence relating to shortages that require Center-level 

clearance.

CDER Office of Strategic Programs (OSP), International Program will: 

• Provide shortage management expertise to non-U.S. regulatory authorities.

• Assist with identifying potential non-U.S. sources of drug products in shortage when 

no alternative products are available in the U.S.

• Notify the DSS of potential or actual shortages in non-U.S. countries, which may 

impact the drug product supply in the U.S.

FDA Office of Regulatory Affairs (ORA) Coordinators will: 

• Provide shortage management expertise to FDA District Offices.

• Notify RSB of potential shortage situations discovered during inspections.

• Notify Imports Exports Compliance Branch (IECB) of potential shortage situations 

due to product being held at a port. IECB will work with RSB to determine CDER 

recommendations for such shipments.

• In conjunction with IECB, facilitate the entry process for drugs from alternate sources 

to alleviate drug shortages.

PROCEDURES

The following steps are to be taken when a potential or actual drug shortage is reported

from a manufacturer, FDA office, or an external entity:

The DSS will determine whether an actual drug shortage exists by: 

1. Determining if the current product demand is stable or increasing based on 

historical data using a market research database.

2. Contacting product manufacturer(s) to provide accurate inventory information, 

manufacturing schedules, and any changes in ordering patterns.

3. Evaluating product distribution at the wholesale level, if needed.

4. Assessing information obtained from market research, manufacturer(s), and 

wholesaler(s) to determine if an actual drug shortage exists.
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5. Requesting a new or updated Medical Necessity Determination Form from the 

division(s) with the requisite expertise on that drug product, if needed.

6. Collecting the same information as in steps 1 – 4, above, for acceptable 

alternative drug product(s), if acceptable alternative drug product(s) exist.

7. Establishing a risk versus benefit profile related to an OC or OPQ action and the 

potential for a resulting drug shortage, when applicable. This profile will be 

established with input from the DSS and any other organizational entity 

mentioned in the Responsibilities section of this MAPP. 

8. Monitoring the shortage situation until resolution.

The DSS will consider that a product is in shortage if:

1. Historic national demand for product within the U.S. is not being met.

2. The manufacturer of the product and those making alternative products are not 

able to meet demand or to increase production to cover the shortfall.

3. There is notice from the public or practitioners about the lack of product available 

in the market.

Exploration of Alternative Sources: 

When a potential or actual shortage might be resolved by obtaining a drug from an 

alternate source, the DSS will:

• Contact CDER OSP, International Programs (i.e., OSP and IP) to identify a potential 

drug supplier. If a drug supplier is identified, request relevant information from the 

drug supplier(s).

• Coordinate an internal review of relevant information with other Agency offices. 

Meet with the potential supplier to discuss compliance requirements.

• Notify the Centers for Medicare and Medicaid Services (CMS) of the product(s) to be 

obtained from the alternate source.

• Coordinate issuance and clearance of a Dear Healthcare Provider Letter, if known 

risks regarding the product should be communicated to healthcare professionals.

• Discuss shipping logistics with the alternate source, including entry information.

• Notify RSB of the product port location and entry information for communication to 

the district and port.

• Monitor the shortage situation. Determine when product from the alternate source is 

no longer needed.

• Communicate with appropriate Agency offices to ensure the proper controls are in 

place when product from the alternate source is no longer needed.
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Originating Office: Office of the Center Director

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When the DSS identifies a firm willing and able to divert existing product into the U.S. 

market to address a shortage, the DSS will ask for the following information from the 

firm to start the review of the alternate source product:

• Amount of product available for supply. Product should be currently manufactured

because there is not enough time to dedicate a new manufacturing line to address 

shortage need. 

• Product strength(s), dosage form(s), presentation(s), and expiration date(s) for the 

batch(es) and lot(s). 

• Addresses for all drug substance and finished dosage form manufacturing and testing 

sites, and inspectional histories, including the relevant regulatory authority. 

• Batch records, Certificates of Analysis, tests, and release specifications for the 

batch(es) and lot(s). 

• Copies of the current labels and label inserts and English translations, if necessary. 

• Draft of the Dear Healthcare Provider letter (to outline to physicians and practitioners 

any differences between the alternate source product and the U.S. marketed product

in shortage).

• Distribution plan for the product. All costs associated with procurement of the 

product, shipment, and distribution are covered by the sponsor. The DSS may request

sensitivity to the price, in light of the drug shortage; however, the DSS will not advise 

the firm or manufacturer on distribution or price.

Requests for Expedited Review or Expedited Inspection:

If the DSS is requesting an expedited review or expedited inspection, the DSS will notify 

OND, OGD, OPQ, or OC, as appropriate, that such expedited action is requested. The 

request will be accompanied by information to justify the expedited review or inspection 

or both, such as the extent and severity of the shortage. 

Shortages of Controlled Substances and Requests for Adjustment in Drug 

Enforcement Agency (DEA) Quotas: 

When the DSS receives notification of a potential or actual shortage of a Schedule II 

controlled substance subject to a product quota, the DSS will:

1. Determine if the shortage notification is related to Drug Enforcement Agency 

(DEA) quota allocation (notification either from an API manufacturer or a 

finished dosage form manufacturer). 

2. If the shortage notification is related to a DEA quota allocation, assess whether an 

increase in quota allocation is necessary to help prevent or mitigate a shortage. In 

making this assessment, request from the manfacturer the expected timeframe 

when manufacturing will cease and when a shortage may begin if additional quota 

is not granted. As appropriate, the DSS assessment will also take account 

whether other manufacturers have sufficient quota and could cover the market in 

the absence of an increase in quota allocation. 
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3. If a shortage is confirmed for the Schedule II product, the product and related 

shortage information will be posted on the FDA CDER Drug Shortage website 

under current shortages.

4. If the DSS determines that an increase in quota is necessary to help prevent or 

mitigate a shortage, contact the DEA to facilitate the manufacturer’s request to the 

DEA for an increase in quota. In particular, provide the DEA information related 

to the potential or actual shortage and the expected market impact if the 

manufacturer’s quota request were to be denied in part or in full. 

5. If the DEA denies the manufacturer’s request for an increase in quota and 

provides the denial letter to the DSS, post the denial letter on the Drug Shortage 

Website.

6. If the DSS’s work to facilitate the manufacturer’s request for additional quota 

does not yield a sufficient increase in quota allocation to address the shortage, 

FDA will submit a formal written request to the DEA to increase the quota 

allocation, taking into consideration the levels determined necessary by the 

manufacturer.

7. If the formal FDA request to the DEA to increase the quota allocation is denied,

post the denial letter on the FDA CDER Drug Shortage Website.

MCM Drug Shortages: 

When a potential or actual shortage of an MCM drug is reported, the DSS will:

• Notify CTECS of all potential or actual shortages and discontinuances related to 

drugs with known MCM uses or that involve the SNS or the US military. 

Note: Information on this group of drugs (MCMs) may not be posted on the 

CDER Drug Shortage Website because of national security considerations.

• Enter MCM drug shortage information in the drug shortage database.

Outsourcing Facilities:

When CDER OC becomes aware of specific risks or actions that may lead to disruptions 

in supply from an outsourcing facility that compounds or repackages drugs, CDER OC 

will inform DSS.

The DSS will review the drugs made at the outsourcing facility and the risks related to 

the facility to enhance overall understanding of the marketplace involving the identified 

products. The DSS will: 

1. Notify CDER OC if the drugs made at the outsourcing facility are currently in 

shortage or known to be vulnerable to shortage. 

2. Respond to CDER OC if there could be worsening of shortages, at the local or 

national level, for the drugs that are already in shortage taking into consideration 

that actions may need to be taken due to the risks observed at the facility. 
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3. Continue to use all the tools available under FDA’s current authority to address 

the identified potential shortages.

DSS Website Updates:

When the DSS has confirmed an actual drug shortage exists, the DSS will post this 

information on the Drug Shortage Website. 

Note: The Drug Shortage Website is updated daily. DSS does not post products 

until they are in shortage. This is to avoid creating any shortage. All information 

is verified with manufacturers.

Removal of postings from the “Current Drug Shortages” section of the Drug Shortage 

Website and placing of information in the “Resolved Drug Shortages” section of the 

Drug Shortage Website occurs when the DSS determines a shortage has been resolved 

based on drug supply information from applicant(s) or manufacturer(s) and historical 

market data. This information should include:

• The drug name, the drug manufacturer, and contact information for the manufacturer 

of the drug.

• The date of the initial posting on the Drug Shortage Website and the date of the 

resolution.

• Any relevant information related to the shortage resolution.

Updates to the “Discontinuations” section of the Drug Shortage Website with information 

provided by manufacturers regarding products that will no longer be manufactured 

should include:

• The drug name, the drug manufacturer, presentation, dosage form, and contact 

information for the manufacturer of the drug.

• The date of the notification and posting.

• Any relevant information related to the discontinuation.
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REFERENCES

1. The White House, 2011. Executive Order 13588, Reducing Prescription Drug 

Shortages.

2. Food and Drug Administration Safety and Innovation Act, 2012, Title X.

3. Federal Food, Drug, and Cosmetic Act, Sec. 506C.

4. FDA, 2013, Strategic Plan for Preventing and Mitigating Drug Shortages.

5. FDA, 2017, Center for Drug Evaluation and Research, MAPP 5240.3: 

Prioritization of the Review of Original ANDAs, Amendments and Supplements.

6. FDA, 2018, Center for Drug Evaluation and Research, MAPP 5310.3: Requests 

for Expedited Review of New Drug Application and Biological License 

Application Prior Approval Supplements Submitted for Chemistry, 

Manufacturing, and Controls Changes.

7. FDA, 2012, Office of Regulatory Affairs, FMD 15, Product Shortage 

Communication.

8. Federal Register Vol. 78, No. 29. February 12, 2013.

________________________________________________________________________

DEFINITIONS 

Drug shortage: A period of time when the demand or projected demand for the drug 

within the United States exceeds the supply of the drug. In general, the DSS 

focuses on shortages of medically necessary products that have a significant effect 

on public health. 

Drug Shortage Staff (DSS): The program office designated by the CDER Director to 

oversee and facilitate the resolution of all drug shortage situations. The DSS also 

monitors the production and availability of emergency and MCM drug products. 

Medical Countermeasure (MCM): Medical countermeasures, or MCMs, are FDAregulated products (biologics, drugs, devices) that may be used in the event of a 

potential public health emergency stemming from a terrorist attack with a 

biological, chemical, or radiological/nuclear material, or a naturally occurring 

emerging infectious disease. MCMs can be used to diagnose, prevent, protect 

from, or treat conditions associated with chemical, biological, radiological, or 

nuclear (CBRN) threats, or emerging infectious diseases.

Medically necessary drug: Any drug product used to diagnose, treat, or prevent a serious 

disease or medical condition for which there is no other drug that is judged by 

CDER medical staff to be an appropriate substitute or there is an inadequate 

supply of an acceptable alternative as determined by the DSS. Off-label uses of 
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 15 of 24

approved drugs, marketed unapproved drugs, and Investigational New Drug 

(IND) drugs may be considered medically necessary. Patient convenience alone 

is an insufficient reason to classify a drug product as medically necessary.

Medical necessity determination: A formal, written assessment made by a CDER medical 

officer or officers with requisite expertise on the drug, stating whether the drug 

meets the definition of medically necessary. Multiple CDER divisions may be 

asked to make this determination when there are approved indications or off-label 

uses requiring the expertise of more than one division. This determination is 

provided to the DSS on the Medical Necessity Determination Form (see 

Attachment 2). 

Strategic National Stockpile (SNS): A federal (non-FDA) asset of medical supplies, 

including drugs, to be used in response to national emergencies (both natural and 

man-made). The SNS is maintained by the Assistant Secretary for Preparedness 

and Response (ASPR). 

________________________________________________________________________

EFFECTIVE DATE

This MAPP is effective 30 days following publication.

CHANGE CONTROL TABLE

Effective

Date

Revision

Number

Revisions

11/12/95 Initial Posted as CDER MAPP 4730.1. 

9/28/06 1 Office of ownership changed from OC to OCD. MAPP number 

changed from 4730.1 to 6003.1, Rev. 1. 

2/3/12 n/a Document recertified, S. Loewke. No changes made.

9/03/14 2 MAPP number changed from 6003.1 to 4190.1, Rev.2 Attachments 

3 – 5 added. Changed the name of the Drug Shortage Program to the 

Drug Shortage Staff. Added Executive Order 13588, FDASIA, 

Strategic Plan for Mitigating and Preventing Drug Shortages, and the 

proposed rule, Permanent Discontinuance or Interruption in 

Manufacturing of Certain Drug or Biological Products, to the 

Background and References sections. Changed the Drug Shortage 

Coordinator to the CDER Deputy Director for Regulatory Programs 

and accordingly, the residence of the DSS. Added procedures for 

the OBP, ORA, and OEP. Confirmed and, when necessary, revised 

existing procedures. Further delineated Responsibilities and 

Procedures sections.

11/30/18 3 Based on CDER reorganization, added CDER Office of 

Pharmaceutical Quality (OPQ) and revised and expanded other 
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 16 of 24

Office responsibilities, as necessary. Added OPQ Drug Shortage 

Coordinator (DSC). Removed ONDQA Team Leader and CDER 

OPS, OBP Drug Shortage Coordinator responsibilities. Renamed 

OCTEC to CTECS. Confirmed and, when necessary, revised 

existing procedures. Revised Drug Shortage Process Flowchart. 

Added DSS Procedure for Request for Expedited Review or 

Expedited Inspection. Revised DSS Procedure for Shortages of 

Controlled Substances and Requests for Adjustment in Drug 

Enforcement Agency (DEA) Quotas.
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 17 of 24

ATTACHMENT 1: Drug Shortage Process Flowchart

Receive initial notification 

of potential drug shortage

Determine if an actual drug shortage exists 

using available information from market 

research database, manufacturers, 

wholesalers, etc.

Does an actual drug 

shortage exist?

Is the product 

determined to be 

medically necessary?

Yes

Use normal process to 

monitor for changes in 

product supply and demand.

No

Is the product 

sole-source?

No Is the product 

sole-source?

Yes

Contact alternate 

manufacturers for 

potential increase in 

product 

manufacturing. 

Reviews of 

applications may be 

expedited. 

No

Consult outside 

stakeholders to 

verify if potential 

issues will result 

from decrease in 

product supply. If 

potential issues will 

result, reassess as a 

medically 

necessary product

Yes

Contact alternate 

manufacturers for 

potential increase 

in product 

manufacturing. 

Reviews of 

applications may be 

expedited.

No

If sole-source 

manufacturer submits 

a supplement, 

expedite review. If 

sole-source 

manufacturer does 

not submit a 

supplement, explore 

possibilities for 

obtaining product 

from an alternate 

source. 

Yes
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 18 of 24

ATTACHMENT 2: Medical Necessity Determination Form

The writable PDF Medical Necessity Determination Form is attached to this MAPP. 

Click the paper clip icon, called “Attachments: View file attachments,” on the left side of 

this PDF document. Then select the document called “Att 2: Medical Necessity 

Determination Form.” Save a copy of the form to your computer’s hard drive to enter 

data.
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 19 of 24

ATTACHMENT 3: Office of Compliance Drug Shortage Consult Form

TO BE COMPLETED BY OFFICE OF COMPLIANCE

1. Complete list of finished drug products and pending applications that will be 

impacted by the enforcement action or Warning Letter

Whenever possible/applicable, the list should include product name, dosage form, 

strength, and NDC number, as well as a list of who markets and distributes the 

product (i.e., identify ownership or customers for contract manufacturer).

2. Brief summary of the potential impact that the violations found could have on 

product quality or safety, including product specific or site specific findings or 

violations, if applicable

3. Recommended action (regulatory action CDER/OC is likely to take), and whether 

such action will likely stop production, or if the action is intended to stop 

production

4. Timing of action

5. Firm FDA Establishment Identifier (FEI) and site address 

6. If the consult involves expansion of a recall, provide the following information 

when available:

a. Product name, strength, NDC number, dosage form, and NDA, ANDA, or 

BLA number

b. Number of lots impacted and quantity per lot.

c. When affected lots were distributed and how much product is on the 

market. 

d. Availability of replacement product. If replacement product is not 

available, when next batch is being manufactured and released.

e. Ability for product to be manufactured at another site or another line.

f. Current market information 

i. Firm estimated burn rate

ii. Inventory within the firm's control

iii. Anticipated stock out date

g. Estimated time to correct the problem

h. Firm's plans both short and long term to resolve the problem
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 20 of 24

TO BE COMPLETED BY THE DRUG SHORTAGE STAFF

For each product impacted please provide the following (may be provided as a separate 

document that includes the following information):

7. Medical necessity determination (please provide completed forms)

8. Market share breakdown

When the product is also marketed by alternate manufacturers, market share of 

those manufacturers should be included as well.

9. Burn rate

Include comments on alternate manufacturers or therapeutic alternatives with 

significant supply. 

10. Capacity of other firms (in a market research database or in the Orange Book) to 

increase production or cover market demand.

Prior to requesting that an alternate manufacturing firm increase production, the 

DSS should confirm with OC that the manufacturing site has an acceptable 

compliance status. OC will provide the DSS with current compliance status on 

alternate manufacturing firms.

11. The DSS assessment of additional factors, including population-specific concerns 

(e.g., pediatric strengths), vulnerability to shortage, vulnerability of therapeutic 

alternatives, and feasibility (capacity and timing) of other firms to increase 

production or cover market demand 
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 21 of 24

ATTACHMENT 4: Shortage Information Summary Form for Requests Initiated by the 

CDER Drug Shortage Staff

CDER Drug Shortage Staff Contact: [Name]

Recommendation/input needed from: ☐ Office of Compliance ☐ OPQ

☐ OGD ☐ Clinical Division

Date of request: [Date]

Date Office of Compliance Recommendation Needed: [Date]

The Drug Shortage Staff (DSS) provides the following information as background 

information to the Office of Compliance (OC), via the Recalls and Shortages Branch; the 

Office of Pharmaceutical Quality (OPQ); the Office of Generic Drugs (OGD); and OND 

clinical divisions when assistance is needed to alleviate, prevent, or resolve a drug 

shortage situation. If an office or division cannot make a recommendation or provide 

input by the requested date, then it should contact [Name] via e-mail 

[name]@fda.hhs.gov or phone [301-796-xxxx] to propose a new date.

1. Firm FEI and site address

2. Product name, strength, NDC number, dosage form, and NDA/ANDA/BLA

number

3. Reason for consult/summary (include what is needed from each office or 

division)

4. Number of lots impacted and quantity per lot. (If applicable)

5. When affected lots were distributed. (If applicable)

6. Medically necessary (please provide completed form)

☐ Yes

☐ No 

☐ Medically necessary by outside consult
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 22 of 24

7. Current market information

a. Burn rate

b. Market share breakdown

c. Inventory within firm’s control

d. Anticipated stock out date

e. When will product(s) be available to alleviate, prevent, or resolve the drug 

shortage? What is the FDA regulatory filing status of current product(s)?

8. Approved suppliers: Are there alternate suppliers listed in the Orange Book 

that are not included in a market research database sales data?

☐ Yes; provide application number(s) and any status information available:

☐ No

Comments: 

9. Pending application(s) in-house (if applicable/known):

10. Pending inspection(s) (if applicable/known):

11. Estimated duration of shortage:

12. Firm’s short- and long-term plans to resolve shortage (attach firm proposal):

13. Overall Drug Shortage recommendation/assessment:

------------------------------------------------------------------------------------------------------------

Is an unapproved drug from an alternate source being proposed in order to alleviate 

the shortage?

☐ No

☐ Yes 

a. Site information of every firm involved in the manufacturing process

(name, address, FEI, if available)

i. Finished product

ii. API

iii. Testing

iv. Packaging and labeling

v. Other (specify function)
MANUAL OF POLICIES AND PROCEDURES

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Originating Office: Office of the Center Director

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b. Has the firm submitted an application (NDA/ANDA/BLA)?

☐Yes; date of submission:

☐No; reason for not submitting an application or anticipated date of 

submission: 

c. In what countries is the product marketed?

d. Is the product approved in another country? If so, which countries?
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4190.1 Rev. 3

Originating Office: Office of the Center Director

Effective Date: 11/13/95; 09/28/06; 9/3/14, 11/30/18 Page 24 of 24

ATTACHMENT 5: Index of Acronyms

ANDA — Abbreviated New Drug Application

API — Active Pharmaceutical Ingredient

ASHP — American Society of Health-System Pharmacists

BLA — Biologics License Application

CDC — Centers for Disease Control and Prevention

CDER — Center for Drug Evaluation and Research

CMC — Chemistry, Manufacturing, and Controls

CMS — Centers for Medicare and Medicaid Services

CTECS — Counterterrorism and Emergency Coordination Staff

DDI — Division of Drug Information

DEA — Drug Enforcement Agency

DOC — Division of Online Communications

DoD — Department of Defense

DSC — Drug Shortage Coordinator

DSS — Drug Shortage Staff

FEI — FDA Establishment Identifier

FDASIA — Food and Drug Administration Safety and Innovation Act

IND — Investigational New Drug Application

IECB — Imports Exports Compliance Branch

IP —International Programs

MCM — Medical Countermeasure

NDA — New Drug Application

NDC — National Drug Code

OBP — Office of Biotechnology Products

OC — Office of Compliance

OCD — Office of the Center Director

OCOMM — Office of Communications

ODSIR — Office of Drug Security, Integrity, and Recalls

OEP — Office of Executive Programs

OGD — Office of Generic Drugs

OND — Office of New Drugs

OPQ — Office of Pharmaceutical Quality

ORA — Office of Regulatory Affairs

OSP — Office of Strategic Programs

RSB — Recalls and Shortages Branch

SNS — Strategic National Stockpile