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DisclosureThe speaker declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

Drug Supply Chain Security Act (DSCSA): How to Comply with

the Law

CAPT Connie Jung, RPh, PhDSenior Policy Advisory for Policy

CDER/Office of ComplianceOffice of Drug, Security, Integrity and Response

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CDER’s Office of Compliance

www.fda.gov

Center for Drug Evaluation and Research

Office of Compliance

Office of Drug Security,

Integrity, & Response

Office of Manufacturing

Quality

Office of Program & Regulatory Operations

Office of Scientific

Investigations

Office of Unapproved Drugs and Labeling

Compliance

ODSIR

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Compliance & Enforcement

Priorities

Quality Safety Initiatives

Data Integrity Assurance

CompoundingSupply Chain Integrity

Unapproved Drugs

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Disclaimer

This presentation is intended only to provide a general overview. It is not intended to be comprehensive nor does it

constitute legal advice. Please refer to the appropriate guidances, regulations, or law for specific information.

FDA documents or notices summarized in this presentation can be found on our

Drug Supply Chain Security Act webpage.

www.fda.gov

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Objectives

• Describe illegitimate product and threats to the drug supply chain

• Describe current responsibilities under the DSCSA for pharmacies (product tracing, verification, and authorized trading partners)

• Discuss common misconceptions and questions about DSCSA requirements

www.fda.gov

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Pharmaceutical Distribution Supply Chain

Who touches the drug before it reaches the patient?

www.fda.gov

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Threats to the Pharmaceutical Supply Chain

www.fda.gov

Unscrupulous players• Distribute illegitimate product• Don’t maintain quality of the product• Don’t maintain security or integrity of the supply chain

(examples: are not authorized or do business with entities that are not authorized)

Illegitimate product Counterfeit, diverted, stolen, intentionally adulterated, subject to a fraudulent transaction, or otherwise unfit for distribution that would result in serious adverse health consequences or death to humans

Weakness in the drug supply chain can be anywhere

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Overview of the DSCSA

Drug Quality and Security

Act

Title I: The Compounding

Quality Act

Title II: Drug Supply Chain Security Act

Product Tracing

WDD and 3PL Licensing and

Standards

• 581 – Definitions• 582 – Requirements

(product tracing, product identification, verification)

• 583 – Standards for licensure of wholesale distributors

• 584 – Standards for licensure of third-party logistics providers (3PLs)

• 585 – Uniform national policy

Title II: Drug Supply Chain Security Act (DSCSA) adds new sections in the Federal Food, Drug and Cosmetic Act (FD&C Act)

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DSCSA Goals

1. Implement an interoperable, electronic tracing of products at the package level by 2023 that will:

1. Implement an interoperable, electronic tracing of products at the package level by 2023 that will:

Enable secure tracing of

product at the package level

Use product identifiers to

verify product at the package

level

Enable prompt response to suspect and illegitimate

products when found

Improve efficiency of

recalls

www.fda.gov

2. Establish national standards for licensure for wholesale distributors and third-party logistics providers

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The DSCSA Path

Licensure standards for 3PLs

and WDDs

3PL and WDD

reporting to FDA

2014-2015

Product tracing,Verification

andAuthorized

trading partners

2015

Product identification (serialization)

2017-2018

Product verification

(down to package

level) 2019+

Electronic, interoperable

system (product tracing

down to package level)

2023

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Trading partners under DSCSA

Manufacturers

Repackagers

Wholesale Distributors (WDDs)

Dispensers (Pharmacies)

Third-party logistics providers (3PLs)

www.fda.gov

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Who is a Dispenser?

• A retail pharmacy, hospital pharmacy, or a group of chain pharmacies under common ownership or control, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities.

• Excludes:– if such entity acts as a wholesale distributor; – a person who only dispenses products used with animals.

www.fda.gov

Refer to definition for “dispenser” in section 581(3) of the FD&C Act.

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Products

• What’s covered: – Prescription drug in finished dosage form for administration to a

patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution)

• What’s not covered:‒ Blood or blood components intended for transfusion‒ Radioactive drugs or biologics‒ Imaging drugs‒ Certain IV products‒ Medical gas‒ Homeopathic drugs‒ Lawfully compounded drugs

Refer to the definition for “product” in section 581(13) of the FD&C Act for specific information regarding exceptions.

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Transactions• Involve transfers of product where a change of ownership occurs• Excludes:

– Intracompany distributions– Distribution among hospitals under common control– Public health emergencies– Dispensed pursuant to a prescription– Product sample distribution– Blood and blood components for transfusion– Minimal quantities by a licensed pharmacy to a licensed practitioner– Certain activities by charitable organizations – Distributions pursuant to a merger or sale – Certain combination products– Certain medical kits– Certain IV products– Medical gas distribution– Approved animal drugs

Refer to the definition for “transaction” in section 581(24) of the FD&C Act for specific information regarding exclusions.

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Authorized Trading Partners

Verification

Product Tracing Product Identification (Serialization)

DSCSA

www.fda.gov

Key Requirements*

*The requirements under section 582 of the FD&C Act apply to manufacturers, repackagers, wholesale distributors, and dispensers (pharmacies).

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Trading partners must be authorized

Manufacturers and Repackagers

• Have valid registration with FDA

• Check FDA’s drug establishment current registration site database (DECRS)

WDDs and 3PLs

• Have valid State or Federal license and compliance with reporting requirements

• Check FDA’s WDD/3PL database

Dispensers (Pharmacies)

• Have valid State license

• Check respective state authorities

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FDA’s Drug Establishment Current Registration Site (DECRS)

• can be used to check for valid registration by manufacturers and repackagers

• publishes currently registered establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S.

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Wholesale Distributor and 3PL Reporting Database

• Reporting licensure to FDA started in 2014 for 3PLs and in 2015 for wholesale distributors

• Single national database

• Self reported information by Wholesale Distributors and 3PLs

• Search capability (by facility name, type, State, or license)

• File download capability

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Guidance: Identifying Trading Partners

Manufacturing establishments, application holders, co-licensed partners, affiliatesManufacturers

Does not include a pharmacy solely engaged in packaging/labeling for an identified patient after receipt of a valid Rx

Repackagers

Differences in the definition of wholesale distribution in PDMA and DSCSA, some entities are now 3PLsWDDs

• “Other logistic services”• Not brokers, solution providers, common carriers, etc.3PLs

No product tracing requirements if product is dispensed to a patient or if it is a dispenser to dispenser sale to fulfill a specific patient need

Dispensers

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Only accept prescription drugs with product tracing information: 1) Transaction Information (TI)2) Transaction History (TH)3) Transaction Statement (TS)

Receive

--Generate and provide product tracing information with each transaction if you sell a prescription drug to another trading partner. --You do not need to provide product tracing information when you dispense a prescription drug to a patient or you sell to a pharmacy for dispensing to a specific patient.

Provide

Respond to a request for information within 2 business days, in the event of a recall or to investigate a suspect or illegitimate product.Respond

Store product tracing information you receive in paper or electronic format for at least 6 years.Store

Return product to the trading partner that you bought the drug fromReturn

Product Tracing Requirement

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Guidances: Standards for product tracing

Standards for the Interoperable Exchange of Information…How to Exchange Product Tracing Information• Can use or build on current systems and processes to comply with requirements• Paper- or electronic-based• Examples of methods that could be used include, but are not limited to:

Invoices, packing slips and electronic data interchange standards (ex. Advance Ship Notice and Electronic Product Code Information Services)

• Email or web-based platforms are acceptable, as long as the information that is captured, maintained, and provided is in compliance with the law

Standardization of Data and Documentation Practices for Product Tracing

• Recommends how to standardize the data contained in product tracing information (TI, TH, TS)• Describes data elements that should be including in product tracing information, including situations where

it is permitted by law for certain data to be omitted‒ Dispenser to dispenser sales to fulfill a specific patient need‒ Drop shipments to a dispenser‒ Grandfathered product

• Use of third-party agreements

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Suspect Product: reason to believe that product potentially is:

• counterfeit, diverted, stolen

• subject of fraudulent transaction

• intentionally adulterated or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

Illegitimate Product: credible evidence shows that the product is:

• counterfeit, diverted, stolen

• subject of fraudulent transaction

• intentionally adulterated or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

Investigate and properly handle suspect and illegitimate products

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Identifying suspect product:Examples of what to look for…

www.fda.gov

Altered product

info

Missing info on label

Bubbling on the label

No “Rx only”

symbol

Missing or wrong package inserts

Damaged, broken

seal, open package

Lot numbers or expiration dates do not

match the outer/inner container

Looks different

than product on shelf

Different product name

than FDA approved

version

Foreign language

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Suspect prescription drugs to determine if illegitimateQuarantine and

Investigate

--Must include validating applicable transaction information and transaction history

--Starting 2020: Verify lot number and product identifierInvestigation

If the product is illegitimate, notify FDA and immediate trading partners within 24 hoursNotify

If the product is illegitimate, work with manufacturer to take steps to prevent it from reaching patientsRespond

Store records of investigation of suspect product and the disposition of illegitimate product for at least 6 yearsStore

Verification Requirements

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Guidances: Verification

Identification of Suspect Product and Notification

Describes scenarios that increase risk of suspect product entering the supply chain:• recommendations on how to identify and make determination of suspect product• sets forth process to notify FDA and consult with FDA to termination notifications

about illegitimate product

Definitions of Suspect Product and Illegitimate Product for Verification Requirements

Clarifies FDA interpretations of terms with in the definitions:• counterfeit, diverted, subject of fraudulent transaction, unfit for distribution• aids in determining when to report an illegitimate product to FDA

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Notify FDA if you have illegitimate product

www.fda.gov

Notify FDA within 24 hours using Form FDA 3911

Notify other trading partners within 24

hours

Request notification termination using

Form FDA 3911

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Product identifier - Serialization

November 2018: Manufacturers/Repackagers• Place product identifiers on prescription drug

packages---Determine smallest individual saleable unit---Human and machine readable format

November 2020: Dispensers• Can only buy/sell product that s serialized

What is the Product Identifier?• National Drug Code (NDC)• Serial Number• Lot Number• Expiration Date

Barcode: 2D data matrix

www.fda.gov

NDC: XXXX-XXXX-XXSERIAL: XXXXXXXXLOT: XXXXXXXEXP: YYYY-MM-DD

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Not all prescription drugs are required to have a product identifier and are excluded.

Excluded Products

Some products will be in the supply chain before the product identifier requirement took effect.

Grandfathered

Some products were granted a waiver or exemption from the product identifier requirement.

Waiver or Exempt

Packages Without Product Identifiers

If you are unsure whether a product should have a product identifier, verify with the manufacturer or repackager.

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Protect your patients

www.fda.gov

Prevent harmful drugs from entering the supply chain.

Detect harmful drugs if they enter the supply chain.

Respond rapidly when harmful drugs are found.

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The DSCSA Path

Licensure standards for 3PLs

and WDDs

3PL and WDD

reporting to FDA

2014-2015

Product tracing,Verification

andAuthorized

trading partners

2015

Product identification (serialization)

2017-2018

Product verification

(down to package

level) 2019+

Electronic, interoperable

system (product tracing

down to package level)

2023

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Challenge QuestionBy 2023, the electronic, interoperable system for product tracing at the package-level established by the Drug Supply Chain Security Act (or DSCSA) will:

A. Facilitate electronic exchange of transaction information for each sale of prescription drugB. Use product identifiers to verify product at the package levelC. Enable prompt response to suspect and illegitimate products when foundD. Improve the efficiency of recallsE. All of the above

www.fda.gov

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Challenge QuestionBy 2023, the electronic, interoperable system for product tracing at the package-level established by the Drug Supply Chain Security Act (or DSCSA) will:

A. Facilitate electronic exchange of transaction information for each sale of prescription drugB. Use product identifiers to verify product at the package levelC. Enable prompt response to suspect and illegitimate products when foundD. Improve the efficiency of recallsE. All of the above

www.fda.gov

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Common Misconceptions and Questions (1)

“Pharmacies are at the end of the supply chain, we don’t need to do anything for DSCSA.”False: DSCSA applies to dispensers (primarily pharmacies).- Review these presentation for product tracing, verification, and authorized trading partner

requirements- Review the law (the Drug Supply Chain Security Act)- Check FDA’s Identifying Trading Partner Guidance and other guidances- Check FDA’s DSCSA website for updates

“DSCSA requirements don’t go into effect for a long time, so we don’t need to think about them now.”False: Product tracing and verification requirements went into effect in 2015. More requirements will be phased in over the next few years with the goal of getting to electronic, unit-level tracing by 2023.

www.fda.gov

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Common Misconceptions and Questions (2)

“As a pharmacy, I can sell to another trading partner and do not need to provide any DSCSA product tracing documentation to the next trading partner.”It depends: Dispensers are not required to provide the product tracing information if the product is dispensed to a patient or if it is a sale by a dispenser to another dispenser to fulfill a “specific patient need.”However, any other transfer of product to another trading partner constitutes wholesale distribution, and you would be subject to the section 582 and 583 requirements for wholesale distributors. - Check FDA’s Identifying Trading Partner Guidance and other guidances- Review the law (the Drug Supply Chain Security Act)

www.fda.gov

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Common Misconceptions and Questions (3)

“DSCSA requirements don’t go into effect for a long time, so we don’t need to think about them now.”False: Product tracing and verification requirements went into effect in 2015. Verification requirements will change for dispensers in 2020. Enhanced product tracing and verification will go into effect in 2023.- Review the law (the Drug Supply Chain Security Act)- Check FDA’s DSCSA guidances- Check FDA’s DSCSA website for updates

www.fda.gov

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Common Misconceptions and Questions (4)

“All prescription drug packages will have a 2D data matrix barcode on them by November 2018.”False: Certain prescription drugs that meet the definition of “product” (section 581(13) of the FD&C Act) are required to have a product identifier, which includes a 2D data matrix barcode. If you not sure, check with the manufacturer or repackager of the product.- Check FDA’s DSCSA guidances- Check FDA’s DSCSA website for updates

www.fda.gov

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Resources• DSCSA webpage

– https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm

• DSCSA regulatory documents (i.e., regulations, guidances, federal register notices, pilot programs)– https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSe

curity/DrugSupplyChainSecurityAct/ucm424963.htm

www.fda.gov

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Key takeaway messages

Confirm that the entities that you do business with are registered or licensed

Receive, store, and provide product tracing documentation

Investigate and properly handle suspect and illegitimate drugs

Be vigilant and diligent!!

www.fda.gov

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Thank You!

www.fda.gov

QUESTIONS?