Division of Supply Chain Integrity
Division of Supply Chain Integrity Mission: To reduce threats to the global drug supply chain through increased transparency and accountability, effective enforcement, and promotion of proactive industry vigilance and voluntary compliance.
Division of Supply Chain Integrity’s two primary goals include:
- Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers; and
- Raising public awareness of drug security threats and vulnerabilities in the supply chain.
On This Page:
- News & Events
- Counterfeit/Unapproved Drugs in U.S. Distribution
- Internet Drug Outlets/Fraudulent Internet Pharmacies
- Prescription Drug Marketing Act (PDMA)
- Supply Chain Security Initiatives
- Cargo Theft/Diversion
- Intentional Adulteration
- Contact Us
- November 28, 2016: Iowa Oncologist Fined $176,000 To Settle False Claims Act Allegations
- November 18, 2016: Palm Harbor Oncologist Convicted Of Buying Unapproved Cancer Medications From Foreign Sources And Defrauding Medicare
- November 10, 2016: Nurse Who Operated Spa in Laguna Niguel Agrees to Plead Guilty to Illegally Dispensing Botox Not Approved for Use in United States
- June 2, 2016: President of Pharmaceutical Companies Sentenced to 60 Months in Prison
- April 26, 2016: Federal Court Orders Seizure of 67 Website Domains
- March 4, 2016: First of Seven Defendants Who Operated Illegal Online Pharmacy Sentenced to Prison
- April 16, 2015: Counterfeit Version of Botox Found in the United States
Counterfeit/Unapproved Drugs in U.S. Distribution
- April 1, 2015: More than 39 Unapproved Drugs Purchased from Gallant Pharmaceutical International or Gallant Medical International
- July 11, 2013: Fraudulent Versions of Botox Sold by Online Botox Pharmacy, Onlinebotox.com, and Onlinebotox
- May 13, 2013: Counterfeit Altuzan distributed by a U.S. company Pharmalogical, Inc., d/b/a Medical Device King
- November 30, 2012: Unapproved Botox Distributed by Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care
- September 10, 2012: Unapproved Prolia and Aclasta Sold by Distributors Owned and Operated by Canada Drugs
- June 28, 2012: Unapproved Altuzan Distributed or Sold Richards Pharma, Quality Special Products, Volunteer Distribution, Clinical Care, and Bridgewater Medical
- February 10, 2012: Counterfeit Avastin Sold by Quality Special Products (QSP), also known as Montana Health Care Solutions
- Counterfeit Medicine
Internet Drug Outlets/Fraudulent Internet Pharmacies
Prescription Drug Marketing Act (PDMA)
- Prescription Drug Marketing Act of 1987
- Verify Wholesale Drug Distributor Licenses
- Guidance for Industry -- Prescription Drug Marketing Act (PDMA) Requirements -- Questions and Answers
We have an electronic mailbox for PDMA reports which we encourage you to use: PDMAREPORTS@fda.hhs.gov.
If you would prefer to mail your reports, please use the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
White Oak Building 51, PDMA Reports Mailbox
10903 New Hampshire Avenue
Silver Spring, MD 20993
Supply Chain Security Initiatives
- Know Your Source: Protecting Patients from Unsafe Drugs
- September 2014: “Importing Injectables,” Journal of Drugs in Dermatology, Kenneth Beer & Karen Rothschild
- FDA Preliminary Report: Review of Counterfeit and Diversion Criminal Case Information-September 2011 (PDF - 140KB)
- Standards Development for Prescription Drug Supply Chain Security
- Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop
Cargo Theft/Diversion
- Cargo Thefts
- Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion to the FDA in the Aftermath of a Natural Disaster
- FDA Urges Industry to Take Additional Steps to Prevent Cargo Theft
Supply Chain issues related to drugs and components:
DrugSupplyChainIntegrity@fda.hhs.gov
Track and Trace:
Drug.trackandtrace@fda.hhs.gov
Report suspected criminal activity:
Inspections, Compliance, Enforcement, and Criminal Investigations
Office of Drug Security, Integrity, and Response
(301) 796-3130
Return to Main Page: Office of Drug Security, Integrity, and Response