Drugs Intended for Human Use That Are Improperly Listed Due to Lack of Annual Certification or Identification of a Manufacturing Establishment Not Duly Registered With the Food and Drug Administration; Action Dates, 40417-40419 [2019-17436]
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: August 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–17398 Filed 8–13–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2374]
Drugs Intended for Human Use That
Are Improperly Listed Due to Lack of
Annual Certification or Identification of
a Manufacturing Establishment Not
Duly Registered With the Food and
Drug Administration; Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of intent.
The Food and Drug
Administration (FDA or Agency) is
announcing its intention to begin
inactivating drug listing records that are
improperly listed in accordance with
FDA requirements because these drug
listings are not certified as being active
and up to date or are associated with a
manufacturing establishment that is not
currently registered with FDA. FDA’s
regulations governing drug
establishment registration and drug
listing require registrants to notify FDA
if commercial distribution of a listed
drug is discontinued. They also require
firms to submit drug listing updates if
any material changes are made to
information previously submitted,
including a change in manufacturing
establishment(s). FDA has found that
listings for many drug products do not
comply with these regulations because
they have not been updated in over a
year, they have not been certified as
being up to date, or they identify within
the listing information at least one
manufacturing establishment that is not
currently registered with FDA. Many of
the drugs that are the subject of these
listings appear to no longer be in
commercial distribution. The purpose of
this notice is to remind registrants of
their legal obligations and announce
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SUMMARY:
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that, if drug listings are not
appropriately updated, certified, or
associated with a registered
establishment, they will be marked by
FDA as ‘‘inactive,’’ and the date of
inactivation will be added to the listing
record. This process will result in the
closure of drug records in all public
drug listing databases maintained by
FDA, including the National Drug Code
(NDC) Directory and the NDC SPL Data
Elements (NSDE) file, until corrections
to the relevant listings are made.
DATES: This notice is applicable
September 13, 2019.
FOR FURTHER INFORMATION CONTACT: Paul
Loebach, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2262, Silver Spring,
MD 20993–0002, 301–796–2173,
Paul.loebach@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 510 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360) and part 207 (21 CFR part 207) of
FDA’s regulations have long required
owners or operators of drug
manufacturing establishments to register
their establishments with FDA. In this
notice, the term ‘‘manufacture’’ refers to
all activities that trigger the drug
establishment registration obligation
under part 207, including repacking,
relabeling, and salvaging as defined in
part 207. Registrants are also required
by section 510 and part 207 to ‘‘list’’
each drug manufactured at their
establishments for commercial
distribution and submit updated drug
listing information to FDA twice yearly,
in June and December, notifying FDA if
this information has changed.
Specifically, section 510(i)(2) and (j) of
the FD&C Act require registered
establishments to report and
periodically update, among other
information, listing information for each
drug manufactured, prepared,
propagated, compounded, or processed
by them for commercial distribution in
the United States. Under 21 CFR 207.49,
207.53, and 207.54, registrants must
provide listing information that
corresponds to the activity or activities
they engage in for that drug.
As part of the drug listing information
they submit to FDA, registrants must
identify all establishments where a
‘‘listed drug’’ (as the term used in the
context of section 510 of the FD&C Act
and part 207) is manufactured or
provide a source NDC that enables FDA
to identify such establishments.
Registered establishments must also
report to FDA the discontinuation of
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40417
commercial distribution of a listed drug
(section 510(j)(2)(B) of the FD&C Act)
and any material change in drug listing
information previously submitted,
which includes any changes in the
establishment(s) where the drug is
manufactured (section 510(j)(2)(D) of the
FD&C Act and 21 CFR 207.1). On
August 31, 2016, FDA amended part 207
to require drug manufacturers and other
registrants, at the time of registration
renewal, to certify that no changes have
occurred to their listings that were not
submitted or updated during the current
calendar year (81 FR 60170 and § 207.57
(21 CFR 207.57)). The first certifications
under this new requirement were due
during the registration renewal period
from October 1 to December 31, 2017
(81 FR 60170 at 60201 and § 207.57).
Establishments and labeler code holders
are also required to update contact
information (name, telephone number,
and email) submitted to FDA within 30
calendar days of any changes (21 CFR
207.25(g), 207.29(a)(3), and
207.33(c)(2)).
Complete, accurate, and up-to-date
establishment registration and drug
listing information is essential to FDA’s
mission. FDA relies on establishment
registration and drug listing information
in administering several key programs,
including drug establishment
inspections, postmarketing surveillance,
counterterrorism, recalls, drug quality
reports, adverse event reports,
monitoring of drug shortages and
availability, supply chain security, and
identification of products that are
marketed without an approved
application. If registration and listing
information is outdated or otherwise
unreliable (such as inaccurate,
superfluous, incomplete, or missing),
the integrity of the drug establishment
registration and listing database—and
FDA’s ability to rely on the reported
information for these programs—is
compromised. Drug registration and
listing information is also widely used
outside FDA for several purposes,
including electronic drug prescribing,
prescription drug reimbursement, and
patient education. A review of our data
shows that the types of errors discussed
in this notice affect tens of thousands of
records. Therefore, the inclusion of such
incorrect or outdated information in
FDA’s NDC Directory, the NSDE file, or
other public drug listing databases can
negatively affect public health.
II. Circumstances Under Which Certain
Drug Listing Information Becomes
Inaccurate
Each registrant must list all drugs it
manufactures for commercial
distribution within 3 days of initial
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14AUN1
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
registration (21 CFR 207.45).
Establishment registration must be
renewed annually between October 1
and December 31 (21 CFR 207.29). Each
registrant must in June and December
each year: (1) Update its drug listing
information to provide FDA with
information about any drugs introduced
for U.S. commercial distribution not
previously listed, (2) report the
discontinuation of any listed drug, and
(3) report any material changes in drug
listing information submitted previously
(including any updates in the
manufacturing establishments)
(§ 207.57). If there are no changes to
listing information to report in June or
December, then the registrant must
certify that there have been no changes
to the listing information previously
submitted, during the October 1 and
December 31 registration renewal and
listing certification period (§ 207.57). By
December 31 of each calendar year,
registrants should review their current
files of listed human drugs to determine
whether any data elements in their drug
listing records are no longer accurate
and submit updated listing files or
listing certifications.
While a new drug listing submission
transmitted to FDA electronically will
not be accepted if the listing
information identifies a manufacturing
establishment that is not registered in
accordance with FDA’s requirements,
previously submitted establishment and
listing information may become
outdated for a variety of reasons. In
some cases, establishments that have
discontinued manufacturing let their
registration expire by not renewing their
annual establishment registration at the
end of the year but fail to update their
drug listing information to report
discontinuation of their listed drug(s).
The result is that listing information for
certain drugs may be certified to be
current but potentially identifies one or
more establishments that are not
currently registered with FDA in
accordance with FDA’s requirements.
In other cases, registrants may
incorrectly include additional
establishments in their drug listing
submissions (for example, in
anticipation of a future business
relationship with a contract
manufacturer). Consistent with the
applicable regulatory requirements in
part 207, FDA expects all
establishments identified in a drug
listing submission to reflect current
manufacturing facilities for the listed
drug at the time of the listing
submission or at the time of the update
so that the Agency can rely on the
information when submitted as an
accurate picture of the supply chain.
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There are also cases in which a
registrant fails to review and update its
previously reported drug listing
information as required in June and
December of each year. Similarly, a
registrant may neglect to certify to FDA
that its listings are still up to date and
accurate. (See section IV of this
document for links to FDA’s NDC
Directory and other resources that may
help registrants determine whether any
data elements in their drug listing
records are no longer accurate and
correct inaccurate drug listings.)
III. FDA’s Intended Response
To address the above registration and
listing problems, FDA is encouraging
firms that are required to register drug
establishments and list human drugs
under part 207 to review their currently
listed human drugs and determine
whether any information in their drug
listings, including drug establishments
identified, is no longer accurate. Any
active drug listing submissions that are
inaccurate should be updated as soon as
possible.
Thirty days after publication of this
notice, and every January thereafter,
FDA will begin to inactivate human
drug listings that remain uncertified
from the previous renewal period of
October 1 to December 31. In addition,
every July thereafter, FDA will begin to
inactivate human drug listings that
remain active and certified after the
June listing update, but still contain at
least one establishment that is not
currently registered in accordance with
FDA’s requirements. This action taken
by FDA will include listings for finished
drug products, as well as for active
pharmaceutical ingredients and other
unfinished drugs. These listing records,
including their NDCs, will be
inactivated and subject to immediate
removal from FDA’s NDC Directory and
notification of each NDC’s inactivation
date will be included in FDA’s NSDE
file. NDCs that are inactivated by FDA
may be reactivated with an updated and
compliant drug listing submission as
soon as the next business day. If
activated again, the listing will again be
included in the NDC Directory and the
reactivation date will be included in the
NSDE file. If a drug remains in
commercial distribution after it has been
inactivated and removed from the NDC
Directory, the drug may be deemed
misbranded for failure to fulfill
registration or listing obligations under
section 502(o) of the FD&C Act (21
U.S.C. 352(o)), and persons marketing
the drug in the United States or offering
it for import into the United States may
be subject to enforcement.
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Manufacturers and repackagers of
products subject to the new product
identification requirement (see section
582(b)(2) and (e)(2) of the FD&C Act,
respectively (21 U.S.C. 360eee–1(b)(2)
and (e)(2))), and who have incorporated
the new product identifier
(serialization) into their labeling, must
submit such updated labeling with
listing updates (§ 207.57) and not
merely certify that affected listings are
up to date via ‘‘no changes’’
certifications during the registration
renewal period. Such a change requires
that a new and representative sample of
labeling incorporating the new product
identifier requirements be submitted as
an update to listing (§ 207.57). Note that
such an update would satisfy the annual
certification requirement for the drug
listing and not require an additional
‘‘blanket no changes’’ submission to
maintain the listing’s active status.
Firms are required by law to update
their drug listings when they
discontinue marketing their listed drugs
(§ 207.57). To properly discontinue a
listed drug, the listing record must be
updated to include an accurate
marketing end date that corresponds
with the last lot expiration date of the
drug (§ 207.57(b)(ii)). If the listing
record expires without an update,
certification, or discontinuance
submitted, the process described above
will assign an inactivation date that is
different from the actual date of
discontinuance and may have
unintended consequences for
dispensing and reimbursement. Rather
than explicitly discontinuing certain
listings, some firms have notified FDA
that they do not intend to certify or
update those listings. However, listing
certification is a separate requirement
and should not be treated as a
mechanism to discontinue the drug
listing record.
IV. Resources Available To Assist With
Updating or Certifying Drug Listings
The NDC Directory (available at:
https://www.fda.gov/Drugs/Information
OnDrugs/ucm142438.htm) currently
identifies all active, but uncertified,
listings. The online search marks
uncertified listings with a ‘‘(U)’’ in red
font. The online search also marks
active but otherwise deficient or
erroneous listing records with an ‘‘(E)’’.
Listing records marked with an ‘‘(E)’’
have been identified by FDA as having
an error or deficiency associated with
the submission. These include, but are
not limited to, records with at least one
establishment that is not registered in
accordance with FDA’s requirements.
All listing records should be reviewed
for accuracy at least biannually,
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
regardless of whether they have been
marked as deficient or not. Within the
download files for the NDC Directory,
uncertified listings may be identified
using the LISTING CERTIFIED
THROUGH DATE column. Any value
that appears in this date field occurring
in the past identifies a product listing
that has not been certified. Erroneous or
deficient listings are identified by a
value of ‘‘E’’ in the EXCLUDE FLAG
column.
Updates and certifications to listing
information must be provided
electronically in Structured Product
Labeling (SPL) format. Anyone seeking
information on how to update listing
information may visit www.fda.gov/
edrls or contact edrls@fda.hhs.gov.
Additionally, FDA offers two SPL
authoring tools for use in the creation
and submission of SPL: Xforms and
CDER Direct. Xforms is available from
FDA’s SPL web page at: https://
www.fda.gov/ForIndustry/
DataStandards/StructuredProduct
Labeling/default.htm. CDER Direct is
available at: https://direct.fda.gov.
Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17436 Filed 8–13–19; 8:45 am]
BILLING CODE 4164–01–P
Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed—21 CFR
589.2000(e)(1)(iv)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
13, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0339. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–3794, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–0339—
Extension
Section 701(a) (21 U.S.C. 371(a)) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) gives us the authority to
issue regulations for the efficient
enforcement of the FD&C Act. Our
regulation at 21 CFR 589.2000 provides
that animal protein derived from
mammalian tissue (with some
exclusions) is not generally recognized
as safe (GRAS) for use in ruminant feed
and is a food additive subject to certain
provisions of the act (62 FR 30936, June
5, 1997).
This information collection was
established because epidemiological
evidence gathered in the United
Kingdom suggested that bovine
40419
spongiform encephalopathy (BSE), a
progressively degenerative central
nervous system disease, is spread to
ruminant animals by feeding protein
derived from ruminants infected with
BSE. This regulation places general
requirements on persons that
manufacture, blend, process, and
distribute products that contain, or may
contain, protein derived from
mammalian tissue, and feeds made from
such products.
Specifically, this regulation requires
renderers, feed manufacturers, and
others involved in feed and feed
ingredient manufacturing and
distribution to maintain written
procedures specifying the cleanout
procedures or other means and
specifying the procedures for separating
products that contain or may contain
protein derived from mammalian tissue
from all other protein products from the
time of receipt until the time of
shipment. These written procedures are
intended to help the firm formalize their
processes, and then to help inspection
personnel confirm that the firm is
operating in compliance with the
regulation. Inspection personnel will
evaluate the written procedure and
confirm it is being followed when they
are conducting an inspection.
These written procedures must be
maintained as long as the facility is
operating in a manner that necessitates
the record, and if the facility makes
changes to an applicable procedure or
process the record must be updated.
Written procedures required by this
section shall be made available for
inspection and copying by FDA.
Description of Respondents:
Respondents include renderers, feed
manufacturers, and others involved in
feed and feed ingredient manufacturing
and distribution.
In the Federal Register of December
21, 2018 (83 FR 65681), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
in support of the collection of
information.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
589.2000(e)(1)(iv); written procedures ................................
320
1
320
14
4,480
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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]]>Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40417-40419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17436]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2374]
Drugs Intended for Human Use That Are Improperly Listed Due to
Lack of Annual Certification or Identification of a Manufacturing
Establishment Not Duly Registered With the Food and Drug
Administration; Action Dates
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of intent.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
its intention to begin inactivating drug listing records that are
improperly listed in accordance with FDA requirements because these
drug listings are not certified as being active and up to date or are
associated with a manufacturing establishment that is not currently
registered with FDA. FDA's regulations governing drug establishment
registration and drug listing require registrants to notify FDA if
commercial distribution of a listed drug is discontinued. They also
require firms to submit drug listing updates if any material changes
are made to information previously submitted, including a change in
manufacturing establishment(s). FDA has found that listings for many
drug products do not comply with these regulations because they have
not been updated in over a year, they have not been certified as being
up to date, or they identify within the listing information at least
one manufacturing establishment that is not currently registered with
FDA. Many of the drugs that are the subject of these listings appear to
no longer be in commercial distribution. The purpose of this notice is
to remind registrants of their legal obligations and announce that, if
drug listings are not appropriately updated, certified, or associated
with a registered establishment, they will be marked by FDA as
``inactive,'' and the date of inactivation will be added to the listing
record. This process will result in the closure of drug records in all
public drug listing databases maintained by FDA, including the National
Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file,
until corrections to the relevant listings are made.
DATES: This notice is applicable September 13, 2019.
FOR FURTHER INFORMATION CONTACT: Paul Loebach, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993-0002, 301-
796-2173, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360) and part 207 (21 CFR part 207) of FDA's regulations
have long required owners or operators of drug manufacturing
establishments to register their establishments with FDA. In this
notice, the term ``manufacture'' refers to all activities that trigger
the drug establishment registration obligation under part 207,
including repacking, relabeling, and salvaging as defined in part 207.
Registrants are also required by section 510 and part 207 to ``list''
each drug manufactured at their establishments for commercial
distribution and submit updated drug listing information to FDA twice
yearly, in June and December, notifying FDA if this information has
changed. Specifically, section 510(i)(2) and (j) of the FD&C Act
require registered establishments to report and periodically update,
among other information, listing information for each drug
manufactured, prepared, propagated, compounded, or processed by them
for commercial distribution in the United States. Under 21 CFR 207.49,
207.53, and 207.54, registrants must provide listing information that
corresponds to the activity or activities they engage in for that drug.
As part of the drug listing information they submit to FDA,
registrants must identify all establishments where a ``listed drug''
(as the term used in the context of section 510 of the FD&C Act and
part 207) is manufactured or provide a source NDC that enables FDA to
identify such establishments. Registered establishments must also
report to FDA the discontinuation of commercial distribution of a
listed drug (section 510(j)(2)(B) of the FD&C Act) and any material
change in drug listing information previously submitted, which includes
any changes in the establishment(s) where the drug is manufactured
(section 510(j)(2)(D) of the FD&C Act and 21 CFR 207.1). On August 31,
2016, FDA amended part 207 to require drug manufacturers and other
registrants, at the time of registration renewal, to certify that no
changes have occurred to their listings that were not submitted or
updated during the current calendar year (81 FR 60170 and Sec. 207.57
(21 CFR 207.57)). The first certifications under this new requirement
were due during the registration renewal period from October 1 to
December 31, 2017 (81 FR 60170 at 60201 and Sec. 207.57).
Establishments and labeler code holders are also required to update
contact information (name, telephone number, and email) submitted to
FDA within 30 calendar days of any changes (21 CFR 207.25(g),
207.29(a)(3), and 207.33(c)(2)).
Complete, accurate, and up-to-date establishment registration and
drug listing information is essential to FDA's mission. FDA relies on
establishment registration and drug listing information in
administering several key programs, including drug establishment
inspections, postmarketing surveillance, counterterrorism, recalls,
drug quality reports, adverse event reports, monitoring of drug
shortages and availability, supply chain security, and identification
of products that are marketed without an approved application. If
registration and listing information is outdated or otherwise
unreliable (such as inaccurate, superfluous, incomplete, or missing),
the integrity of the drug establishment registration and listing
database--and FDA's ability to rely on the reported information for
these programs--is compromised. Drug registration and listing
information is also widely used outside FDA for several purposes,
including electronic drug prescribing, prescription drug reimbursement,
and patient education. A review of our data shows that the types of
errors discussed in this notice affect tens of thousands of records.
Therefore, the inclusion of such incorrect or outdated information in
FDA's NDC Directory, the NSDE file, or other public drug listing
databases can negatively affect public health.
II. Circumstances Under Which Certain Drug Listing Information Becomes
Inaccurate
Each registrant must list all drugs it manufactures for commercial
distribution within 3 days of initial
[[Page 40418]]
registration (21 CFR 207.45). Establishment registration must be
renewed annually between October 1 and December 31 (21 CFR 207.29).
Each registrant must in June and December each year: (1) Update its
drug listing information to provide FDA with information about any
drugs introduced for U.S. commercial distribution not previously
listed, (2) report the discontinuation of any listed drug, and (3)
report any material changes in drug listing information submitted
previously (including any updates in the manufacturing establishments)
(Sec. 207.57). If there are no changes to listing information to
report in June or December, then the registrant must certify that there
have been no changes to the listing information previously submitted,
during the October 1 and December 31 registration renewal and listing
certification period (Sec. 207.57). By December 31 of each calendar
year, registrants should review their current files of listed human
drugs to determine whether any data elements in their drug listing
records are no longer accurate and submit updated listing files or
listing certifications.
While a new drug listing submission transmitted to FDA
electronically will not be accepted if the listing information
identifies a manufacturing establishment that is not registered in
accordance with FDA's requirements, previously submitted establishment
and listing information may become outdated for a variety of reasons.
In some cases, establishments that have discontinued manufacturing let
their registration expire by not renewing their annual establishment
registration at the end of the year but fail to update their drug
listing information to report discontinuation of their listed drug(s).
The result is that listing information for certain drugs may be
certified to be current but potentially identifies one or more
establishments that are not currently registered with FDA in accordance
with FDA's requirements.
In other cases, registrants may incorrectly include additional
establishments in their drug listing submissions (for example, in
anticipation of a future business relationship with a contract
manufacturer). Consistent with the applicable regulatory requirements
in part 207, FDA expects all establishments identified in a drug
listing submission to reflect current manufacturing facilities for the
listed drug at the time of the listing submission or at the time of the
update so that the Agency can rely on the information when submitted as
an accurate picture of the supply chain. There are also cases in which
a registrant fails to review and update its previously reported drug
listing information as required in June and December of each year.
Similarly, a registrant may neglect to certify to FDA that its listings
are still up to date and accurate. (See section IV of this document for
links to FDA's NDC Directory and other resources that may help
registrants determine whether any data elements in their drug listing
records are no longer accurate and correct inaccurate drug listings.)
III. FDA's Intended Response
To address the above registration and listing problems, FDA is
encouraging firms that are required to register drug establishments and
list human drugs under part 207 to review their currently listed human
drugs and determine whether any information in their drug listings,
including drug establishments identified, is no longer accurate. Any
active drug listing submissions that are inaccurate should be updated
as soon as possible.
Thirty days after publication of this notice, and every January
thereafter, FDA will begin to inactivate human drug listings that
remain uncertified from the previous renewal period of October 1 to
December 31. In addition, every July thereafter, FDA will begin to
inactivate human drug listings that remain active and certified after
the June listing update, but still contain at least one establishment
that is not currently registered in accordance with FDA's requirements.
This action taken by FDA will include listings for finished drug
products, as well as for active pharmaceutical ingredients and other
unfinished drugs. These listing records, including their NDCs, will be
inactivated and subject to immediate removal from FDA's NDC Directory
and notification of each NDC's inactivation date will be included in
FDA's NSDE file. NDCs that are inactivated by FDA may be reactivated
with an updated and compliant drug listing submission as soon as the
next business day. If activated again, the listing will again be
included in the NDC Directory and the reactivation date will be
included in the NSDE file. If a drug remains in commercial distribution
after it has been inactivated and removed from the NDC Directory, the
drug may be deemed misbranded for failure to fulfill registration or
listing obligations under section 502(o) of the FD&C Act (21 U.S.C.
352(o)), and persons marketing the drug in the United States or
offering it for import into the United States may be subject to
enforcement.
Manufacturers and repackagers of products subject to the new
product identification requirement (see section 582(b)(2) and (e)(2) of
the FD&C Act, respectively (21 U.S.C. 360eee-1(b)(2) and (e)(2))), and
who have incorporated the new product identifier (serialization) into
their labeling, must submit such updated labeling with listing updates
(Sec. 207.57) and not merely certify that affected listings are up to
date via ``no changes'' certifications during the registration renewal
period. Such a change requires that a new and representative sample of
labeling incorporating the new product identifier requirements be
submitted as an update to listing (Sec. 207.57). Note that such an
update would satisfy the annual certification requirement for the drug
listing and not require an additional ``blanket no changes'' submission
to maintain the listing's active status.
Firms are required by law to update their drug listings when they
discontinue marketing their listed drugs (Sec. 207.57). To properly
discontinue a listed drug, the listing record must be updated to
include an accurate marketing end date that corresponds with the last
lot expiration date of the drug (Sec. 207.57(b)(ii)). If the listing
record expires without an update, certification, or discontinuance
submitted, the process described above will assign an inactivation date
that is different from the actual date of discontinuance and may have
unintended consequences for dispensing and reimbursement. Rather than
explicitly discontinuing certain listings, some firms have notified FDA
that they do not intend to certify or update those listings. However,
listing certification is a separate requirement and should not be
treated as a mechanism to discontinue the drug listing record.
IV. Resources Available To Assist With Updating or Certifying Drug
Listings
The NDC Directory (available at: https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) currently identifies all active, but
uncertified, listings. The online search marks uncertified listings
with a ``(U)'' in red font. The online search also marks active but
otherwise deficient or erroneous listing records with an ``(E)''.
Listing records marked with an ``(E)'' have been identified by FDA as
having an error or deficiency associated with the submission. These
include, but are not limited to, records with at least one
establishment that is not registered in accordance with FDA's
requirements. All listing records should be reviewed for accuracy at
least biannually,
[[Page 40419]]
regardless of whether they have been marked as deficient or not. Within
the download files for the NDC Directory, uncertified listings may be
identified using the LISTING CERTIFIED THROUGH DATE column. Any value
that appears in this date field occurring in the past identifies a
product listing that has not been certified. Erroneous or deficient
listings are identified by a value of ``E'' in the EXCLUDE FLAG column.
Updates and certifications to listing information must be provided
electronically in Structured Product Labeling (SPL) format. Anyone
seeking information on how to update listing information may visit
www.fda.gov/edrls or contact [email protected]. Additionally, FDA
offers two SPL authoring tools for use in the creation and submission
of SPL: Xforms and CDER Direct. Xforms is available from FDA's SPL web
page at: https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. CDER Direct is available at:
https://direct.fda.gov.
Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17436 Filed 8-13-19; 8:45 am]
BILLING CODE 4164-01-P
