82 FR 30868 - Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 126 (July 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 126 (July 3, 2017)
| Page Range | 30868-30870 | |
| FR Document | 2017-13979 |
[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)] [Notices] [Pages 30868-30870] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13979] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2232] Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy.'' This draft guidance describes FDA's intention with regard to enforcement of requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). Specifically, this guidance addresses manufacturers' product identifier and verification requirements, which begin November 27, 2017. This guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 1, 2017. ADDRESSES: You may submit comments 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 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-2017-D-2232 for ``Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy; Draft Guidance for Industry; Availability.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as [[Page 30869]] ``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. 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.thefederalregister.org/fdsys/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. Submit written requests for single copies of the draft 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; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Connie Jung, 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The DSCSA (Title II of Pub. L. 113-54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360eee- 1). This section established product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain. Failure to comply with the requirements of section 582 is also a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)). Beginning November 27, 2017, manufacturers are required, under section 582(b)(2)(A) of the FD&C Act, to ``affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce.'' Also beginning on November 27, 2017, section 582(b)(4)(A)(i)(II) of the FD&C Act requires manufacturers to verify the product at the package level, including the standardized numerical identifier, which is part of the product identifier, when they determine that the product in their possession or control is suspect or they receive a verification request from FDA. Section 582(b)(4)(C) of the FD&C Act requires a manufacturer, upon receiving a request from an authorized trading partner that believes a product in its possession or control was manufactured by the manufacturer, to verify whether the product identifier on a product corresponds with the product identifier affixed or imprinted by the manufacturer. Section 582(b)(4)(E) of the FD&C Act requires manufacturers to verify the product identifier of a package or a sealed homogenous case of a saleable returned product before the manufacturer further distributes such product. In addition, under section 582(e)(2)(A)(iii) of the FD&C Act, beginning on November 27, 2018, repackagers may engage in transactions involving a product only if such product is encoded with a product identifier, unless the product is grandfathered under section 582(a)(5) of the FD&C Act. This same requirement applies to wholesale distributors beginning on November 27, 2019, under section 582(c)(2) of the FD&C Act, and to dispensers beginning on November 27, 2020, under section 582(d)(2) of the FD&C Act. Additionally, under section 582(c)(4)(A)(i)(II), (d)(4)(A)(ii)(II), and (e)(4)(A)(i)(II) of the FD&C Act, wholesale distributors, dispensers, and repackagers are required to verify the product at the package level, including the standardized numerical identifier, which is part of the product identifier, to investigate a suspect product. For a saleable returned product, the wholesale distributor or repackager must verify the product identifier, including the standardized numerical identifier, of each package or sealed homogenous case of such product before it further distributes such product, under section 582(c)(4)(D) and (e)(4)(E) of the FD&C Act, respectively. As described in the draft guidance, FDA has received comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers and describing challenges they face. Given the concerns expressed, FDA recognizes that some manufacturers may need additional time beyond November 27, 2017, to ensure that products are properly labeled with a product identifier. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA has adopted the compliance policy described in the guidance. Under this compliance policy, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to their packages and homogenous cases of product that are intended to be introduced in a transaction into commerce between November 27, 2017, and November 26, 2018. For such product that does not contain a product identifier and was first introduced in a transaction into commerce by the manufacturer between November 27, 2017, and November 26, 2018, FDA also does not intend to take action against manufacturers who do not use the product identifier to verify a product at the package level when investigating suspect product, upon receiving a verification request from FDA, after receiving a request from an authorized trading partner, or for a saleable returned product. This guidance also explains that, for a product that does not have a product identifier and that was first introduced [[Page 30870]] in a transaction into commerce by the manufacturer between November 27, 2017, and November 26, 2018, FDA does not intend to take action against: (1) Repackagers who accept ownership of such product in a transaction; (2) wholesale distributors who engage in transactions involving such product; and (3) dispensers who engage in transactions involving such product, or repackagers, wholesale distributors, and dispensers who do not verify the product at the package level, using the product identifier, when investigating suspect product or for a saleable returned product as applicable. In addition, the guidance explains that FDA does not intend to take action against a manufacturer, repackager, or wholesale distributor who engages in certain prohibited acts involving products that are misbranded based on lack of product identifier alone, where the package and/or homogeneous case of product that lacks a product identifier was introduced in a transaction into commerce by a manufacturer between November 27, 2017, and November 26, 2018. The guidance document explains the scope of the compliance policy in further detail. FDA invites comment on the compliance policy, including comments on how manufacturers can indicate the date they initially introduced the product in a transaction into commerce and how downstream trading partners can determine that product was initially introduced by manufacturers in a transaction into commerce during that time period. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy.'' 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. This is not a significant regulatory action subject to Executive Order 12866. II. Electronic Access Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: June 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13979 Filed 6-30-17; 8:45 am] BILLING CODE 4164-01-P
![30868 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
Medical Necessity Disclosure Under Disclosure Request Form DATES: Although you can comment on
MHPAEA Group health plan participants, any guidance at any time (see 21 CFR
MHPAEA section 512(b) specifically beneficiaries, covered individuals in the 10.115(g)(5)), to ensure that the Agency
amends the Public Health Service (PHS) individual market, or persons acting on considers your comment on this draft
Act to require plan administrators or their behalf, may use this optional guidance before it begins work on the
health insurance issuers to provide, model form to request information from final version of the guidance, submit
upon request, the criteria for medical plans regarding NQTLs that may affect either electronic or written comments
necessity determinations made with patients’ MH/SUD benefits or that may on the draft guidance by September 1,
respect to MH/SUD benefits to current have resulted in their coverage being 2017.
or potential participants, beneficiaries, denied. Form Number: CMS–10307; ADDRESSES: You may submit comments
or contracting providers. The Interim Frequency: On Occasion; Affected as follows:
Final Rules Under the Paul Wellstone Public: State, Local, or Tribal Electronic Submissions
and Pete Domenici Mental Health Parity Governments, Private Sector,
Submit electronic comments in the
and Addiction Equity Act of 2008 (75 Individuals; Number of Respondents:
following way:
FR 5410, February 2, 2010) and the 267,538; Number of Responses: • Federal eRulemaking Portal:
Final Rules under the Paul Wellstone 1,081,929; Total Annual Hours: 43,327. https://www.regulations.gov. Follow the
and Pete Domenici Mental Health Parity (For policy questions regarding this instructions for submitting comments.
and Addiction Equity Act of 2008 set collection contact Usree Comments submitted electronically,
forth rules for providing criteria for Bandyopadhyay at 410–786–6650). including attachments, to https://
medical necessity determinations. CMS Dated: June 28, 2017. www.regulations.gov will be posted to
oversees non-Federal governmental William N. Parham, III, the docket unchanged. Because your
plans and health insurance issuers. comment will be made public, you are
Director, Paperwork Reduction Staff, Office
Claims Denial Disclosure Under of Strategic Operations and Regulatory solely responsible for ensuring that your
MHPAEA Affairs. comment does not include any
[FR Doc. 2017–13973 Filed 6–30–17; 8:45 am] confidential information that you or a
MHPAEA section 512(b) specifically
BILLING CODE 4120–01–P third party may not wish to be posted,
amends the PHS Act to require plan
such as medical information, your or
administrators or health insurance
anyone else’s Social Security number, or
issuers to supply, upon request, the
DEPARTMENT OF HEALTH AND confidential business information, such
reason for any denial or reimbursement
HUMAN SERVICES as a manufacturing process. Please note
of payment for MH/SUD services to the
that if you include your name, contact
participant or beneficiary involved in Food and Drug Administration information, or other information that
the case. The Interim Final Rules Under
[Docket No. FDA–2017–D–2232] identifies you in the body of your
the Paul Wellstone and Pete Domenici
comments, that information will be
Mental Health Parity and Addiction
Product Identifier Requirements Under posted on https://www.regulations.gov.
Equity Act of 2008 (75 FR 5410, • If you want to submit a comment
the Drug Supply Chain Security Act—
February 2, 2010) and the Final Rules with confidential information that you
Compliance Policy; Draft Guidance for
under the Paul Wellstone and Pete do not wish to be made available to the
Industry; Availability
Domenici Mental Health Parity and public, submit the comment as a
Addiction Equity Act of 2008 AGENCY: Food and Drug Administration, written/paper submission and in the
implement 45 CFR 146.136(d)(2), which HHS. manner detailed (see ‘‘Written/Paper
sets forth rules for providing reasons for ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’).
claims denial. CMS oversees non-
Federal governmental plans and health SUMMARY: The Food and Drug Written/Paper Submissions
insurance issuers, and the regulation Administration (FDA or Agency) is Submit written/paper submissions as
provides a safe harbor such that non- announcing the availability of a draft follows:
Federal governmental plans (and issuers guidance for industry entitled ‘‘Product • Mail/Hand delivery/Courier (for
offering coverage in connection with Identifier Requirements Under the Drug written/paper submissions): Dockets
such plans) are deemed to comply with Supply Chain Security Act— Management Staff (HFA–305), Food and
requirements of paragraph (d)(2) of 45 Compliance Policy.’’ This draft Drug Administration, 5630 Fishers
CFR 146.136 if they provide the reason guidance describes FDA’s intention Lane, Rm. 1061, Rockville, MD 20852.
for claims denial in a form and manner with regard to enforcement of • For written/paper comments
consistent with ERISA requirements requirements related to product submitted to the Dockets Management
found in 29 CFR 2560.503–1. Section identifiers under the Drug Supply Chain Staff, FDA will post your comment, as
146.136(d)(3) of the final rule clarifies Security Act (DSCSA). Specifically, this well as any attachments, except for
that PHS Act section 2719 governing guidance addresses manufacturers’ information submitted, marked, and
internal claims and appeals and external product identifier and verification identified, as confidential, if submitted
review as implemented by 45 CFR requirements, which begin November as detailed in ‘‘Instructions.’’
147.136, covers MHPAEA claims 27, 2017. This guidance also addresses Instructions: All submissions received
denials and requires that, when a non- certain requirements for repackagers, must include the Docket No. FDA–
quantitative treatment limitation wholesale distributors, and dispensers 2017–D–2232 for ‘‘Product Identifier
sradovich on DSK3GMQ082PROD with NOTICES
(NQTL) is the basis for a claims denial, to only engage in transactions involving Requirements Under the Drug Supply
that a non-grandfathered plan or issuer products with product identifiers and to Chain Security Act—Compliance Policy;
must provide the processes, strategies, verify the product identifier when Draft Guidance for Industry;
evidentiary standard, and other factors investigating suspect product, in Availability.’’ Received comments,
used in developing and applying the addition to repackager and wholesale those filed in a timely manner (see
NQTL with respect to med/surg benefits distributor requirements related to DATES), will be placed in the docket and,
and MH/SUD benefits. saleable returned products. except for those submitted as
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![30870 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices
in a transaction into commerce by the Dated: June 28, 2017. 375(b)) gives FDA authority to
manufacturer between November 27, Anna K. Abram, disseminate information concerning
2017, and November 26, 2018, FDA Deputy Commissioner for Policy, Planning, suspected or imminent danger to public
does not intend to take action against: Legislation, and Analysis. health by any regulated product. Section
(1) Repackagers who accept ownership [FR Doc. 2017–13979 Filed 6–30–17; 8:45 am] 1701(a)(4) of the Public Health Service
of such product in a transaction; (2) BILLING CODE 4164–01–P Act (42 U.S.C. 300u(a)(4)) also
wholesale distributors who engage in authorizes FDA to conduct research
transactions involving such product; relating to health information.
and (3) dispensers who engage in DEPARTMENT OF HEALTH AND
transactions involving such product, or HUMAN SERVICES FDA’s Center for Devices and
repackagers, wholesale distributors, and Radiological Health (CDRH) carries out
dispensers who do not verify the Food and Drug Administration FDA’s regulatory responsibilities
product at the package level, using the [Docket No. FDA–2009–N–0360]
regarding medical devices and
product identifier, when investigating radiological products. CDRH must be
suspect product or for a saleable Agency Information Collection able to effectively communicate risk to
returned product as applicable. In Activities; Submission for Office of health care practitioners, patients,
addition, the guidance explains that Management and Budget Review; caregivers, and consumers when there is
FDA does not intend to take action Comment Request; Food and Drug a real or suspected threat to the public’s
against a manufacturer, repackager, or Administration Safety Communication health. CDRH uses safety
wholesale distributor who engages in Readership Survey communications to transmit information
certain prohibited acts involving concerning these risks to user
products that are misbranded based on AGENCY: Food and Drug Administration,
HHS. communities. Safety communications
lack of product identifier alone, where are released and available to
the package and/or homogeneous case ACTION: Notice.
organizations such as hospitals, nursing
of product that lacks a product identifier SUMMARY: The Food and Drug homes, hospices, home health care
was introduced in a transaction into Administration (FDA) is announcing agencies, manufacturers, retail
commerce by a manufacturer between that a proposed collection of
November 27, 2017, and November 26, pharmacies, and other health care
information has been submitted to the providers, as well as patients,
2018. The guidance document explains Office of Management and Budget
the scope of the compliance policy in caregivers, consumers, and patient
(OMB) for review and clearance under advocacy groups. Through a process for
further detail. FDA invites comment on the Paperwork Reduction Act of 1995.
the compliance policy, including identifying and addressing postmarket
DATES: Fax written comments on the safety issues related to regulated
comments on how manufacturers can
collection of information by August 2, products, CDRH determines when to
indicate the date they initially
2017. release safety communications.
introduced the product in a transaction
into commerce and how downstream ADDRESSES: To ensure that comments on
FDA seeks to evaluate the clarity,
trading partners can determine that the information collection are received, timeliness, and impact of safety
product was initially introduced by OMB recommends that written
communications by surveying a sample
manufacturers in a transaction into comments be faxed to the Office of
Information and Regulatory Affairs, of recipients and obtain their voluntary
commerce during that time period. responses to determine the impact of
This draft guidance is being issued OMB, Attn: FDA Desk Officer, FAX:
consistent with FDA’s good guidance 202–395–7285, or emailed to oira_ safety communications on the
practices regulation (21 CFR 10.115). submission@omb.eop.gov. All knowledge of the recipients.
The draft guidance, when finalized, will comments should be identified with the Understanding how the target audiences
represent the current thinking of FDA OMB control number 0910–0341. Also view these publications will aid in
on ‘‘Product Identifier Requirements include the FDA docket number found determining what, if any, changes
Under the Drug Supply Chain Security in brackets in the heading of this should be considered in their content,
Act—Compliance Policy.’’ It does not document. format, and method of dissemination.
establish any rights for any person and FOR FURTHER INFORMATION CONTACT: The collection of this data is an
is not binding on FDA or the public. Amber Sanford, Office of Operations, important step in determining how well
You can use an alternative approach if Food and Drug Administration, Three CDRH is communicating risk. The
it satisfies the requirements of the White Flint North 10A63, 11601 results from this survey will emphasize
applicable statutes and regulations. This Landsdown St., North Bethesda, MD the quality of the safety
is not a significant regulatory action 20852, 301–796–8867, PRAStaff@ communications and customer
subject to Executive Order 12866. fda.hhs.gov. satisfaction. This will enable us to better
II. Electronic Access SUPPLEMENTARY INFORMATION: In serve the public by improving the
compliance with 44 U.S.C. 3507, FDA effectiveness of safety communications.
Persons with access to the Internet
may obtain the draft guidance at https:// has submitted the following proposed In the Federal Register of March 15,
www.fda.gov/Drugs/ collection of information to OMB for 2017 (82 FR 13814), FDA published a
GuidanceComplianceRegulatory review and clearance. 60-day notice requesting public
comment on the proposed collection of
sradovich on DSK3GMQ082PROD with NOTICES
Information/Guidances/default.htm, FDA Safety Communication Readership
https://www.fda.gov/ Survey information. No comments were
BiologicsBloodVaccines/ received.
GuidanceCompliance OMB Control Number 0910–0341—
Extension FDA estimates the burden of this
RegulatoryInformation/Guidances/ collection of information as follows:
default.htm, or https:// Section 705(b) of the Federal Food,
www.regulations.gov. Drug, and Cosmetic Act (21 U.S.C.
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Document Created: 2018-11-14 10:19:29
Document Modified: 2018-11-14 10:19:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 1, 2017. | |
| Contact | Connie Jung, 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, [email protected] | |
| FR Citation | 82 FR 30868 |
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