Global Market Intelligence Service Serialization … Market Intelligence Service Serialization Regulation Report United States April 13, 2015 ... 2023 Interoperable System) .....15

Global Market Intelligence Service Serialization Regulation Report

United States

April 13, 2015 Version 5.0

Proprietary and Confidential 2

TABLE OF CONTENTS

Executive Summary ................................................................................................................................... 3

Timeline for Compliance ........................................................................................................................... 4

Transaction Documents (Phase I – Lot Traceability) ................................................................................. 4

Transaction History ............................................................................................................................... 4

Transaction Information ....................................................................................................................... 4

Transaction Statement .......................................................................................................................... 5

Methods of Compliance ........................................................................................................................ 5

Exemptions (Trading Conditions and Products) ................................................................................ 5

Reporting Requirements ....................................................................................................................... 8

Wholesaler Reporting Requirements ................................................................................................ 8

3PL Reporting Requirements ............................................................................................................ 8

Timing of Submissions ....................................................................................................................... 9

Preferred Submission Format and Method ...................................................................................... 9

Database ......................................................................................................................................... 10

Additional 2015 Requirements ........................................................................................................... 10

Labeling and Data Carriers (Phase II – Serialization) ............................................................................... 10

Satisfying SNI through the use of ‘Widely Recognized International Standards’ ............................... 11

Converting NDCs to GTIN .................................................................................................................... 12

Labeling at the Saleable Unit .............................................................................................................. 13

Labeling at Intermediate Packaging Levels ......................................................................................... 13

18 Digit Serialized Shipping Container Code (SSCC18) ........................................................................ 14

Modulo 10 Algorithm Calculation for Check Digit .............................................................................. 15

Aggregation and Inference (Phase III – 2023 Interoperable System) ..................................................... 15

Future FDA Guidance .............................................................................................................................. 17

References .............................................................................................................................................. 18


Executive Summary H.R. 3204 is a bicameral bill stemmed from H.R. 1919 and S. 959. The bill enacts regulations over a

phased in time line, with the goal of increasing traceability throughout the pharmaceutical supply

chain in the United States. The legislation is also known as the Drug Quality and Security Act of 2013,

or DQSA. Title II of the DQSA is the section of the act that specifically addresses traceability of the

pharmaceutical supply chain and is also known as the Drug Supply Chain Security Act, or DSCSA.

The DQSA officially became law as a result of the following actions by the federal government:

September 28, 2013: Passed House by unanimous consent

November 18, 2013: Passed Senate by a voice vote

November 27, 2013: Signed by President Obama

Prior to the DSCSA, the industry had been tracking towards California Board of Pharmacy (CABoP)

State Pedigree Law, the DSCSA pre-empts all state legislation regarding pharmaceutical pedigree and

traceability. As a result, stakeholders in the pharmaceutical supply chain are reevaluating their

serialization programs based on the new federal law. While initially the federal law seems to extend

timelines for serialization compliance, the first phase of the regulation came into effect only 13

months after the bill’s enactment (January 1, 2015).

The DSCSA establishes a phased timeline for compliance. Initial requirements, effective January 1,

2015, include the passing of transaction history (TH), transaction statement (TS), and transaction

information (TI) including lot level information from the manufacturer through the supply chain to the

dispensary. The second phase, in addition to the requirements included in phase 1, will require

serialization at the unit level and the ability to verify the same by all supply chain participants. The

ultimate goal of the DSCSA is to establish an interoperable system to track and trace pharmaceutical

product. This will eventually be accomplished through input from the industry, public meetings, and

pilot projects overseen by the FDA. The Guidance documents that have been released are included in

this summary and cited. This document will be updated to include future guidance documents as they

are officially released by the FDA for each phase in a staggered timeline.

Moving forward, it will be the responsibility of the manufacturers (November 2017 deadline) and

repackagers (November 2018 deadline) to affix the unique product identifier to each drug package.

Wholesalers (November 2019 deadlines) and dispensers (November 2020 deadlines) may not engage

in transactions unless product has a product identifier. Additionally, wholesalers and dispensers

must have the ability to verify product at the package level (saleable unit) and must verify saleable

returns including SNI (standardized numerical identifier) for sealed cases or at the package level.

Wholesalers and dispensers may satisfy this requirement by means of electronic database.


While the regulations for sale of pharmaceutical products in the United States has been defined by

this legislation, it still is imperative to coordinate with trading partners to determine if specific

business requirements are being satisfied by implementing serialization solutions. Guidance from the

Healthcare Distribution Management Association (HDMA) and GS1 standards should also be strongly

considered when implementing solutions to satisfy this law.

Timeline for Compliance

Transaction Documents (Phase I – Lot Traceability) By January 1, 2015, every participant which engages in a transaction that changes ownership of a

pharmaceutical product must provide the downstream trading partner with transaction history,

transaction information, and a transaction statement, in a single document in a paper or electronic

format. Each supply chain entity must maintain a record of transaction documentation for six years

after the date of the transaction. The Secretary shall publish the standards within one year after the

date of enactment of the DQSA. The Secretary shall gather comments for a period of at least 60 days

from all stakeholders before issuing guidance. In November 2017 (4 years after enactment) the

transaction documents are required to be in electronic format – paper will no longer be acceptable.

Transaction History

The term ‘transaction history’ means a statement in paper or electronic form, including the

transaction information for each prior transaction going back to the manufacturer of the product.

Transaction Information

Transaction Information – The term ‘transaction information’ means:


The proprietary or established name or names of the product

The strength and dosage form of the product

The National Drug Code number of the product

The container size

The number of containers

The lot number of the product

The date of the transaction

The date of the shipment, if more than 24 hours after the date of the transaction

The business name and address of the person from whom ownership is being transferred

The business name and address of the person to whom ownership is being transferred

Transaction Statement

Transaction Statement – The ‘transaction statement’ is a statement, in paper or electronic form, that

the entity transferring ownership in a transaction:

Is authorized as required under the Drug Supply Chain Security Act

Received the product from a person that is authorized as required under the Drug Supply

Chain Security Act

Received transaction information and a transaction statement from the prior owner of the

product

Did not knowingly ship a suspect or illegitimate product

Had systems and processes in place to comply with verification requirements

Did not knowingly provide false transaction information

Did not knowingly alter the transaction history

Methods of Compliance

Paper or electronic versions of invoices

Paper versions of packing slips

EDI standards, such as an 856 ASN

EPCIS

Portal (web)

Exemptions (Trading Conditions and Products)

Exemptions 1-5 are exempt from the term ‘transaction,’ the remaining exemptions are product

related. In general, the term ‘transaction’ means the transfer of product between persons in which a

change of ownership occurs. The following items are exempt from transaction history:

1. Intracompany distribution of any product between members of an affiliate or within a

manufacturer

2. The distribution of a product among hospitals or other health care entities that are under

common control


3. The distribution of a product for emergency medical reasons including a public health

emergency declaration pursuant to section 319 of the Public Health Service Act, except that a

drug shortage not caused by a public health emergency shall not constitute an emergency

medical reason

4. The dispensing of a product pursuant to a prescription executed in accordance with section

503(b)(1)

5. The distribution of product samples by a manufacturer or a licensed wholesale distributor in

accordance with section 503(d)

6. The distribution of blood or blood components intended for transfusion;

7. The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed

practitioner for office use

8. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a

charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986 to

a nonprofit affiliate of the organization to the extent otherwise permitted by law

9. The distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a

wholesale distributor or wholesale distributors, except that any records required to be

maintained for the product shall be transferred to the new owner of the pharmacy or

pharmacies or wholesale distributor or wholesale distributors

10. The dispensing of a product approved under section 512(c) (Veterinary Drugs)

11. Products transferred to or from any facility that is licensed by the Nuclear Regulatory

Commission or by a State pursuant to an agreement with such Commission under section 274

of the Atomic Energy Act of 1954 (42 U.S.C. 2021)

12. A combination product that is not subject to approval under section 505 or licensure under

section 351 of the Public Health Service Act, and that is—

A. A product comprised of a device and 1 or more other regulated components (such as

a drug/device, biologic/device, or drug/device/biologic) that are physically,

chemically, or otherwise combined or mixed and produced as a single entity;

B. 2 or more separate products packaged together in a single package or as a unit and

comprised of a drug and device or device and biological product; or

C. 2 or more finished medical devices plus one or more drug or biological products that

are packaged together in what is referred to as a ‘medical convenience kit’ as

described in clause (xiii)

13. The distribution of a collection of finished medical devices, which may include a product or

biological product, assembled in kit form strictly for the convenience of the purchaser or user

(referred to in this clause as a ‘medical convenience kit’) if—

A. The medical convenience kit is assembled in an establishment that is registered with

the Food and Drug Administration as a device manufacturer in accordance with

section 510(b)(2)


B. The medical convenience kit does not contain a controlled substance that appears in

a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of

1970

C. In the case of a medical convenience kit that includes a product, the person that

manufacturers the kit—

i. Purchased such product directly from the pharmaceutical manufacturer or

from a wholesale distributor that purchased the product directly from the

pharmaceutical manufacturer; and

ii. Does not alter the primary container or label of the product as purchased

from the manufacturer or wholesale distributor

D. In the case of a medical convenience kit that includes a product, the product is

i. An intravenous solution intended for the replenishment of fluids and

electrolytes

ii. A product intended to maintain the equilibrium of water and minerals in the

body

iii. A product intended for irrigation or reconstitution;

iv. An anesthetic

v. An anticoagulant

A vasopressor

vi. A sympathomimetic

14. The distribution of an intravenous product that, by its formulation, is intended for the

replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories

(such as dextrose and amino acids)

15. The distribution of an intravenous product used to maintain the equilibrium of water and

minerals in the body, such as dialysis solutions

16. The distribution of a product that is intended for irrigation, or sterile water, whether intended

for such purposes or for injection

17. The distribution of a medical gas (as defined in section 575)

18. The distribution or sale of any licensed product under section 351 of the Public Health Service

Act that meets the definition of a device under section 201(h)

19. Radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title

21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or

by a State pursuant to an agreement with such Commission under section 274 of the Atomic

Energy Act of 1954 (42 U.S.C. 2021)

20. Imaging drugs

21. Homeopathic drugs marketed in accordance with applicable guidance under this Act

22. A drug compounded in compliance with section 503A or 503B of H.R. 3204


Reporting Requirements

Wholesaler Reporting Requirements

Under Section 503(e)(2)(A)&(B), as amended by the DSCSA, beginning January 1, 2015, wholesale

distributors must report to the FDA (http://www.fda.gov/wdd3plreporting):

Identification of each facility

Name of company (same as on license; recommended)

Address of Facility

Contact Information (name, email address and phone number)

All trading names that the company does business

Licensure information for each state:

State

State license number

Significant Disciplinary action

FDA recommends any action within the last 12 months

Identify the type of disciplinary action

State where disciplinary action occurred

Each facility should provide:

Unique Facility Identifier

Expiration date for the license

Documents associated with the disciplinary action, such as consent decree, final State

Board ruing, etc.

3PL Reporting Requirements

Under section 584(b) of the Federal Food, Drug and Cosmetic Act, as amended by the DSCSA,

beginning November 27, 2014, 3PLS must report to the FDA (http://www.fda.gov/wdd3plreporting):

Name of company (FDA recommends providing the company name in the same form as it

appears on the license)

Address of the facility

All trading names that the company does business as

Licensure information for each State

State

State license number (identification number)

Each Facility should provide:

Contact Information (name, email address and phone number)

Unique facility identifier – D-U-N-S (obtain a DUNS @ http://www.dnb.com)

Expiration Date for the license

http://www.fda.gov/wdd3plreporting


http://www.dnb.com/


Significant disciplinary action by any State or Federal agency that occurred in the 12 months

preceding the initial report

State the disciplinary action occurred

Date of Final Action

Type of disciplinary action

Description of violation

Documents associated with the disciplinary action such as consent decree, final state

Board ruling, etc.

Wholesale distributors and 3PLs will be licensed by the State from which the drug is distributed or by

the FDA if that State does not have a licensure program. State licensure information must be provided

for each State in which distribution occurs and are distributed with State licensure programs and for

each State that requires a license to ship product. 3PLS, until regulation changes become effective,

may not have to report to FDA about specific state licensure programs unless otherwise required by a

State 3PL license program. If a facility is both a Wholesale Distributor and a 3PL provider, they should

submit both sets of information to the FDA separately.

Timing of Submissions

Initial report:

Wholesale Distributors: January 1, 2015 – March 31, 2015

3PLs: November 27, 2014 – March 31, 2015

Wholesale distributor and 3PL facilities that are newly licensed after the dates noted above

should initially report within 30 days of obtaining a State or Federal License.

Subsequent Annual Reports:

Wholesale distributors: January 1, 2015 – March 31, 2015 annually.

3PLs: January 1 – March 31 annually

Significant Disciplinary Action Reports (Dates reflect after a final ruling/action):

Wholesale distributors and 3PLs: within 30 days of final action

Other Voluntary Reports:

A company should notify the FDA if a facility goes out of business or decides to withdraw a

State or Federal license with 30 days.

Preferred Submission Format and Method

The FDA prefers the use of extensible markup language (XML) files in a standard Structured

Product Labeling (SPL) format through the FDA Electronic Submissions Gateway (ESG)


o Outsourced facilities will be expected to register by electronic means unless the FDA

grants a waiver to the facility.

Portal: http://www.fda.gov/wdd3plreporting

o The portal will convert the submissions to the appropriate XML files.

o The portal will allow setup for all a company’s facilities at once.

For alternative methods, email [email protected].

Database

The DSCSA requires the FDA to make a database of authorized wholesale distributor and outsourcing

facilities available to the Public on their website. The FDA also believes that it would be beneficial to

make 3PL information available. The FDA intends to make all of this information available to the

extent of the law. The ultimate goal is to create a single database for all wholesaler and 3PL licensing

and facility information available for download at http://www.fda.gov/wdd3plreporting.

Additional 2015 Requirements

Verification – Beginning not later than January 1, 2015, all supply chain entities must have systems in

place to enable the manufacturer to comply with the following requirements:

• Quarantine suspect product

• Notify the Secretary within 24 hours

• Determine whether a product is illegitimate

• Keep records regarding suspect product from the previous 6 years of suspect product

Labeling and Data Carriers (Phase II – Serialization) Manufacturers (November 2017) and repackagers (November 2018) will be required by the DSCSA to

implement the information in this section as it pertains to labeling and data carriers.

Unless the Secretary allows, through guidance, the use of other technologies for data instead of or in

addition to the technologies the applicable data:

Shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon,

a package

Shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or

imprinted upon, a homogeneous case

Verification of the product identifier may occur by using human-readable or machine-

readable methods

The DSCSA defines the following terms as they pertain to labeling:

Package – a ‘package’ as smallest individual saleable unit of product for distribution by a

manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of

such product.


mailto:[email protected]



Product Identifier —The term ‘product identifier’ means a standardized graphic that includes, in both

human readable form and on a machine-readable data carrier that conforms to the standards

developed by a widely recognized international standards development organization, the

standardized numerical identifier, lot number, and expiration date of the product.

Standardized Numerical Identifier – The term ‘standardized numerical identifier’ means a set of

numbers or characters used to uniquely identify each package or homogenous case that is composed

of the National Drug Code that corresponds to the specific product (including the particular package

configuration) combined with a unique alphanumeric serial number of up to 20 characters.

Additionally, a package that is required to have a standardized numerical identifier is not required to

have a unique device identifier.

While the regulation does not specify, GS1 standards should be anticipated as the ‘widely recognized

international standards’ that will be incorporated to accomplish unit level serialization. In addition to

GS1 standards, repackagers and manufacturers should strongly consider guidance of the HDMA.

While the HDMA adopts the use of GS1 standards, the actual incorporation of guidance differs slightly

between these two organizations in a few instances. While the guidance may differ, business

requirements of trading partners should be the driver for making business decisions regarding

labeling and/or data carriers.

Satisfying SNI through the use of ‘Widely Recognized International Standards’

The text of the regulation explains that a 2D data matrix will be embedded with lot, expiration, date

and the SNI at the saleable. The SNI as described in the previous section is the NDC of the product in

addition to a serial number of up to 20 alphanumeric characters. The example below is derived from

the March 2010 FDA guidance on SNI and is a direct explanation of the guidance.

However, to adopt GS1 standards, the National Drug Code (NDC) will need to be converted to a 14

digit Global Trade Item Number (GTIN). The following section explains this direct conversation. A

GTIN paired with a serial number will satisfy the SNI requirement outlined in DQSA because there is

an NDC embedded within the GTIN.


Converting NDCs to GTIN

Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known

as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler

code, is assigned by the FDA. A labeler is any firm that manufactures (including re-packers or re-

labelers), or distributes (under its own name) the drug. The second segment, the product code,

identifies a specific strength, dosage form, and formulation for a particular firm. The third segment,

the package code, identifies package sizes and types. Both the product and package codes are

assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

There are four steps for creating the 14-digit GTIN with an NDC embedded:

Step 1: Position one is the Indicator digit. This digit is zero through eight. It will vary according to the

packaging level. In the example below the Indicator digit is 0.

Step 2 The next two positions (2 and 3) must be 03 for products identified by NDCs or NHRICs. A

numeric digit 3 in Position three indicates that the 10 digits in Positions four through thirteen are

either a NDC or NHRIC.

Step 3: The NDC or NHRIC number consists of a variable length Labeler Code on the left (assigned by

the FDA; either four or five digits long) and a variable length

Product/Package Code on the right (assigned by the holder of the Labeler Code; either five or six digits

long).

Step 4: Position fourteen is a Check Digit for the entire GTIN. This number is calculated using the 13

preceding digits. In our particular example, the calculated Check Digit 0 is placed in Position fourteen.1

1 www.fda.gov


Note: Conversion of NDC to GS1 standard GTIN does not give a drug manufacturer or repackager the

legal right to use it in trade – the GS1 company prefix must be registered with GS1-US before they can

be legally used in GS1 standard carrier (barcoding) systems.

Labeling at the Saleable Unit

The current FDA requirement is to mark drug packages with a linear bar code. While the regulation

has not yet specified, it is anticipated that the FDA will issue guidance if the 2D data matrix at the

saleable unit will replace the linear bar code, or be in addition to the linear. By Nov 27, 2017, all

saleable units impacted by the regulation will be marked with a 2D data matrix encoded with SNI

(assume GTIN plus serial number), lot, and expiration date as well as display the human readable

information (HRI). The order of the HRI and adoption of application identifiers has not yet been

specified. There may be more than one acceptable format for expressing this data in HRI.

Labeling at Intermediate Packaging Levels

The serialization regulation outlines that homogenous cases should be marked with either a linear

barcode or a 2D data matrix. Note that the HDMA recommendation is to include both a 2D bar code

(GS1 standard Data Matrix) in addition to two linear bar codes (GS1-128 standard). As

shown in the example to the right, the top linear bar code should encode expiration

date, lot, and quantity and the bottom linear bar code

should encode GTIN and serial number (the package’s

serialized GTIN). The same information is encoded in the

data matrix as the two linear bar codes. It should be also

be noted that while quantity is not required by the DQSA

(nor is its use, in this format, in strict compliance with

GS1 rules), it is the recommendation of the HDMA. All

application identifiers should be visible in HRI as well – although the adoption of GS1 application

identifiers is not defined in the regulation, the USFDA SNI guidance document does specifically allow

incorporation of data fields in accordance with GS1 standards.

While there is no requirement in the regulation for non-homogenous (mixed cases), the HDMA

recommendation is to incorporate an SSCC18 label on mixed cases (used as logistics units) should be

considered the industry standard. Again, the requirements of trading partners should be strongly

considered when making determinations regarding labeling that is not clearly specified in the

regulation. Please see the following section for a more detailed explanation of this bar code

structure.


18 Digit Serialized Shipping Container Code (SSCC18)

While no regulation is in effect at this time, it should be anticipated that all logistics units should

labeled with an 18-Digit Serialized Shipping Container Code, or SSCC18, as this is consistent with the

HDMA recommendation. The SSCC18 should also be the data carrier on the package of non-

homogeneous cases (mixed product cases).

Application Identifier: The AI "00" indicates the SSCC-18 data structure will follow.

Extension Digit: The Extension Digit has no defined logic and is used to increase the capacity of the

Serial Reference

GS1 Company Prefix: GS1 Company Prefixes are 7-10 digits. Serial Reference Numbers are 6-9 digits.

The combined length of the GS1 Company Prefix and Serial Reference is always 16 digits.

Serial Number: The Serial Reference number is assigned by the holder of the GS1 Company Prefix to

uniquely identify a shipping container (logistic unit). A Serial Reference cannot be reused for a minimum

of 12 months.

Check Digit: Calculated using the Modulo 10 algorithm.2

2 http://www.gs1-128.info/sscc-18


Modulo 10 Algorithm Calculation for Check Digit

The check digit is a number designed to prevent bar code misreading and improvement of reliability

when designating a drug standard code. This calculation, called the Modulo 10 algorithm, is same for

all GS1 primary identification numbers. Every time a computer decodes a GS1 barcode number it

repeats the calculation and checks its answer against the check digit to verify the data integrity of the

number.3 See the example below to recognize how a check digit is calculated.

ID Key

Format Digit positions

GTIN-8 N1 N2 N3 N4 N5 N6 N7 N8

GTIN-12 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12

GTIN-13 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13

GTIN-14 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14

SSCC N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14 N15 N16 N17 N18

Step 1: Multiply value of each position by

x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3

Step 2: Add results together to create sum

Step 3: Subtract the sum from nearest equal or higher multiple of ten = Check Digit

Example

Positions N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13

Number without Check

Digit 6 2 9 1 0 4 1 5 0 0 2 1 -

Step 1: Multiply X X X X X X X X X X X X -

By 1 3 1 3 1 3 1 3 1 3 1 3 -

Step 2: Add results = = = = = = = = = = = = -

to create sum 6 6 9 3 0 12 1 15 0 0 2 3 = 57

Step 3: Subtract the sum from nearest equal or higher multiple of ten = 60- 57 = 3 (Check Digit)

Number with Check Digit 6 2 9 1 0 4 1 5 0 0 2 1 3

Aggregation and Inference (Phase III – 2023 Interoperable System)

The final deadline in 2023 calls for the industry to create an interoperable pharmaceutical supply

chain system that verifies each salable unit as each step in the Supply Chain. In order to comply with

these requirements, Excellis Health Solution recommends that Pharmaceutical Supply Chain

3 http://www.gs1.org/barcodes/support/check_digit_calculator


participants prepare for Aggregation and Inference. Aggregation and Inference are mentioned in the

Drug Supply Chain and Security Act but not defined.

Aggregation is the process of creating, maintaining and transmitting the hierarchical relationships

between each level of packaging, (E.g. Saleable unit to Bundle to Case to Pallet).

Inference is the ability to obtain the hierarchal relationships and encoded data for all of the saleable

units within a shipping container by scanning the label on any level of packaging above the salable

unit (the inference is the connection of the scanned serial identification, for example a case, with the

serial identification for product contained within the case, based on supplied data – this data can be

supplied in hierarchal format in an EPCIS standard XML file).

Aggregation and inference are means of which the industry will be able to verify the contents of any

logistical unit without opening it. These procedures, or similar, will be required to fulfill the 2023

requirements without major disruptions in day-to-day procedures.

This document will be revised to include the guidance on aggregation once the FDA releases it. It is

expected to be titled, “Guidance for Unit Level Traceability.”


Future FDA Guidance The DSCSA has been enacted, but critical details of the regulation have not yet been established.

Accordingly, the FDA plans to issue several additional guidance documents throughout the duration of

this law’s life span. Below are a few key milestones that the FDA has established. While the list may

not be exhaustive, at minimum, the FDA will release these guidance documents within the

timeframes specified:

Guidance for Unit Level Traceability – within 18 months of a public meeting held on inference,

aggregation, and verification.

Guidance for Unit Level Traceability Grandfathering – within 2 years of enactment, guidance for

grandfathering product already in the supply chain that has not been identified with an SNI.

Guidance for Exemptions – within 2 years of enactment, guidance for exemptions to any

requirement. The effective date will be not later than 180 days prior to the date on which

manufacturers are required to affix or imprint a product identifier to each package and homogenous

case of product.

Any revisions to Guidance will be announced by issuing a notice in the Federal Register. Additionally,

each guidance shall be released as draft, with a comment period open to the industry.


References Department of Health and Human Services, US Food and Drug Administration. Drug Quality and

Security Act. USA, 2013.

Department of Health and Human Services, US Food and Drug Administration. DSCSA Standards for

Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:

How to Exchange Product Tracing Information. Guidance for Industry. USA, 2013.

Healthcare Distribution Management Association. HDMA Guidelines for Bar Coding in the

Pharmaceutical Supply Chain. 2011. Print.

http://www.gs1.org/barcodes/support/check_digit_calculator

http://www.gs1-128.info/sscc-18

H.R. 3204, 113 Cong. (2013) (enacted). Print.

Office of the Commissioner (OC), Center for Drug Evaluation and Research (CDER), Center for Biologics

Evaluation and Research (CBER), & Office of Regulatory Affairs (ORA). (2010, March). FINAL

GUIDANCE. Guidance for Industry Standards for Securing the Drug Supply Chain – Standardized

Numerical Identification for Prescription Drug Packages.

www.fda.gov