30054 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

The DSCSA (Title II of Pub. L. 113– 

54) was signed into law on November 

27, 2013. The DSCSA outlines critical 

steps for building an electronic, 

interoperable system by November 27, 

2023, that will identify and trace certain 

prescription drugs as they are 

distributed within the United States. 

Section 202 of the DSCSA added section 

582 to the FD&C Act (21 U.S.C. 360eee– 

1), which established product tracing, 

product identifier, authorized trading 

partner, and verification requirements 

for manufacturers, repackagers, 

wholesale distributors, and dispensers 

to facilitate the tracing of products 

through the pharmaceutical distribution 

supply chain. Section 582 of the FD&C 

Act also imposed requirements for 

enhanced drug distribution security that 

go into effect on November 27, 2023. 

Trading partners, along with Federal 

and State authorities, have a role in 

ensuring the quality of prescription 

drugs and protecting the integrity of the 

pharmaceutical distribution supply 

chain. The DSCSA requirements, which 

have been phased in since 2013, 

improve the oversight of trading 

partners in the supply chain that are 

involved in the manufacturing, 

repackaging, wholesale distribution, 

warehousing or logistical activities, or 

dispensing of prescription drugs. The 

gradual implementation of the DSCSA 

requirements for product tracing, 

product identification, authorized 

trading partners, and verification 

facilitates the development of an 

electronic, interoperable system to 

enhance the security of the 

pharmaceutical distribution supply 

chain. 

Section 582(g)(1) of the FD&C Act sets 

forth the general requirements for 

enhanced drug distribution security, 

including: 

• The exchange of transaction 

information and transaction statements 

in a secure, interoperable, electronic 

manner; 

• transaction information that 

includes the product identifier at the 

package level for each package included 

in the transaction; 

• systems and processes for 

verification of product at the package 

level; and 

• systems and processes needed to 

promptly respond in the event of a 

recall or to investigate suspect and 

illegitimate products. 

This draft guidance clarifies the 

enhanced drug distribution 

requirements and describes 

recommendations for system attributes 

necessary for enhanced product tracing 

and enhanced verification, including 

when the use of aggregation and 

inference may be appropriate. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the current thinking of 

FDA on enhanced drug distribution 

security at the package level under the 

DSCSA. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this draft guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 211.132 for 

tamper-evident packaging of a drug 

product have been approved under 

OMB control number 0910–0139. The 

collections of information in 21 CFR 

201.57 for establishing 

anticounterfeiting technologies, such as 

physical-chemical identifiers, have been 

approved under 0910–0572. The 

collections of information for 

identifying suspect drug product have 

been approved under OMB control 

number 0910–0806. The collections of 

information for establishing: (1) An 

electronic, interoperable system and (2) 

system attributes necessary for enabling 

the secure tracing of drug product have 

been approved under OMB control 

number 0910–0859. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://

www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11734 Filed 6–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0609] 

Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Drug 

Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification.’’ The 

guidance addresses provisions in the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the Drug 

Supply Chain Security Act (DSCSA). 

The guidance is intended to aid certain 

trading partners (manufacturers, 

repackagers, wholesale distributors, and 

dispensers) in identifying a suspect 

product and specific scenarios that 

could significantly increase the risk of a 

suspect product entering the 

pharmaceutical distribution supply 

chain. The guidance also describes how 

trading partners should notify FDA of 

illegitimate product and sets forth a 

process for terminating notifications of 

illegitimate product in consultation 

with FDA. In addition, this guidance 

describes when manufacturers should 

notify FDA of a high risk that a product 

is illegitimate. This guidance responds 

to comments from stakeholders in order 

to clarify certain points and finalizes the 

remaining draft portion of the final 

guidance for industry entitled ‘‘Drug 

Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification,’’ 

issued in December 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 4, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 30055 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–D–0609 for ‘‘Drug Supply Chain 

Security Act Implementation: 

Identification of Suspect Product and 

Notification; Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Drug 

Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification.’’ The 

guidance addresses provisions in the 

FD&C Act, as amended by the DSCSA 

(Pub. L. 113–54). Section 202 of the 

DSCSA adds section 582(h)(2) to the 

FD&C Act (21 U.S.C. 360eee–1(h)(2)), 

which requires FDA to issue guidance to 

aid certain trading partners 

(manufacturers, repackagers, wholesale 

distributors, and dispensers) in 

identifying a suspect product and 

terminating notifications. The guidance 

identifies specific scenarios that could 

significantly increase the risk of a 

suspect product entering the 

pharmaceutical distribution supply 

chain and provides recommendations 

on how trading partners can identify 

such product and determine whether 

the product is a suspect product as soon 

as practicable. 

Beginning January 1, 2015, section 

582 of the FD&C Act required trading 

partners, upon determining that a 

product in their possession or control is 

illegitimate, to notify: (1) FDA and (2) 

all immediate trading partners that they 

have reason to believe may have 

received the illegitimate product, not 

later than 24 hours after making the 

determination. Manufacturers are 

additionally required under section 

582(b)(4)(B)(ii)(II) of the FD&C Act to 

notify FDA and any immediate trading 

partners that the manufacturer has 

reason to believe may possess a product 

manufactured by (or purported to be 

manufactured by) the manufacturer, not 

later than 24 hours after the 

manufacturer determines or is notified 

by FDA or a trading partner that there 

is a high risk that a product is 

illegitimate. The guidance also 

addresses how trading partners should 

notify FDA using Form FDA 3911. In 

addition, in accordance with section 

582(h)(2) of the FD&C Act, the guidance 

sets forth the process by which trading 

partners must terminate the 

notifications using Form FDA 3911, in 

consultation with FDA, regarding 

illegitimate product and, for a 

manufacturer, a product with a high risk 

of illegitimacy, under section 

582(b)(4)(B), (c)(4)(B), (d)(4)(B), and 

(e)(4)(B) of the FD&C Act. 

This guidance finalizes the remaining 

draft portion of the guidance for 

industry entitled ‘‘Drug Supply Chain 

Security Act Implementation: 

Identification of Suspect Product and 

Notification,’’ issued in December 2016. 

In particular, this guidance finalizes 

section III.C, which was issued for 

comment purposes in the December 

2016 guidance. This guidance will now 

be final in its entirety and replaces the 

December 2016 guidance. 

In Federal Register of June 11, 2014 

(79 FR 33564), FDA announced the 

availability of a draft guidance entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification.’’ In 

response to comments received on that 

guidance, in the Federal Register of 

December 9, 2016 (81 FR 89112) FDA 

announced the availability of a guidance 

30056 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

of the same title. This guidance was 

published as a final guidance for 

industry with the exception of Section 

C entitled ‘‘For Manufacturers: High 

Risk of Illegitimacy Notifications’’. This 

new section was published as a draft 

guidance for industry and was added in 

response to comments and questions 

received about the 2014 guidance. In 

addition, based on comments on the 

2014 guidance, Form FDA 3911, and the 

instructions for completing the form, 

were slightly revised. 

FDA received comments on the 2016 

guidance from various stakeholders 

(e.g., pharmacy groups, wholesale 

distributor trade groups). In response to 

these comments, FDA has made some 

changes for clarity to the December 2016 

version of the guidance. The changes 

include: Clarifying what FDA believes 

an ‘‘immediate trading partner’’ to be; 

replacing ‘‘suspicious’’ with 

‘‘questionable’’ throughout the 

document; deleting the reference to 

‘‘pedigree’’ in section III.A.1; clarifying 

that trading partners should consider 

whether product has been subject to a 

public alert or announcement of drug 

quality when considering scenarios that 

could increase the chances that a 

suspect product could enter the supply 

chain; in section III.B, clarifying that 

FDA’s recommendations apply only ‘‘as 

applicable’’ to the individual trading 

partners; clarifying that trading partners 

only work with authorized trading 

partners in section III.B; and stating that 

trading partners should consult with 

manufacturers when conducting an 

investigation of suspect product. 

In response to stakeholder comments, 

FDA has also made some changes to the 

newly final section, III.C. These include: 

Clarifying that while manufacturers 

need not notify FDA of suspect product, 

they must do so if the circumstances 

surrounding the suspect product 

include at least one of three types of 

high risk factors; clarifying that 

manufacturers can learn of product with 

a high risk of illegitimacy either through 

their own investigation of suspect 

product, or through information they 

receive from a variety of other sources, 

including from within their own 

company, from their trading partners, 

from the FDA, or from other domestic 

and/or foreign regulatory authorities; 

clarifying that a manufacturer must 

make a notification to FDA where it is 

investigating the validity of the claim 

that a product has been stolen or 

diverted, and the manufacturer has 

reason to believe that an immediate 

trading partner has the potentially 

stolen or diverted product in its 

possession; and clarifying that while not 

a requirement, FDA does suggest that 

manufacturers inform trading partners 

of ‘‘specific high risk[s]’’. 

Finally, while FDA received a few 

comments on section IV of this 

guidance, which addresses notifications 

for illegitimate products and products 

with a high risk of illegitimacy, along 

with termination of those notifications, 

FDA did not incorporate the feedback 

from comments on response times 

because we feel that a 10-day response 

time is a reasonable amount of time for 

the Agency to review and evaluate such 

requests for the termination of 

notification of illegitimate product. 

Similarly, FDA did not add language on 

disclosure because the information 

submitted to FDA using Form FDA 3911 

is treated like all other records obtained 

by FDA in regard to disclosure. FDA did 

make some revisions for clarity 

however, which include adding a brief 

discussion and footnote to FDA’s 

guidance document Definitions of 

Suspect Product and Illegitimate 

Product for Verification Obligations 

Under the Drug Supply Chain Security 

Act. In addition, editorial changes were 

made throughout the entire guidance for 

clarity and references to section III.C 

being published for comment purposes 

only were removed. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Drug Supply Chain 

Security Act Implementation: 

Identification of Suspect Product and 

Notification.’’ It does not establish any 

rights for any person and, with the 

exception of section IV.B, is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

As noted, section IV.B of this 

guidance, which sets forth the process 

by which trading partners must 

terminate notifications of illegitimate 

product and products with a high risk 

of illegitimacy in consultation with 

FDA, has binding effect, where 

indicated by the use of the words must, 

shall, or required. Such binding effect is 

authorized by section 582(h)(2)(A) of the 

FD&C Act, wherein Congress granted 

authorization to FDA to implement the 

process for terminating notifications of 

illegitimate product in consultation 

with FDA through guidance. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collection of 

information in this guidance has been 

approved under OMB control number 

0910–0806. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

https://www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11732 Filed 6–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–0338] 

Definitions of Suspect Product and 

Illegitimate Product for Verification 

Obligations Under the Drug Supply 

Chain Security Act; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

draft guidance for industry entitled 

‘‘Definitions of Suspect Product and 

Illegitimate Product for Verification 

Obligations Under the Drug Supply 

Chain Security Act.’’ The draft guidance 

is intended to help industry better 

understand the definitions of ‘‘suspect’’ 

and ‘‘illegitimate’’ product as defined in 

the Drug Supply Chain Security Act 

(DSCSA). The draft guidance lays out 

FDA’s current understanding of the 

following key terms used to define 

‘‘suspect’’ and ‘‘illegitimate’’ product: 

‘‘Counterfeit,’’ ‘‘diverted,’’ ‘‘stolen,’’ 

‘‘fraudulent transaction,’’ and ‘‘unfit for 

distribution.’’ This revised draft 

guidance clarifies certain points of the 

draft guidance for industry ‘‘Definitions 

of Suspect Product and Illegitimate 

Product for Verification Obligations 

Under the Drug Supply Chain Security 

Act’’ issued in March 2018 (March 2018