The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments, 63648-63651 [2018-26725]
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Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
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[FR Doc. 2018–26790 Filed 12–10–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket No. FDA–2018–N–4087]
The Food and Drug Administration’s
Proposed Current Good Manufacturing
Practice Policies for Outsourcing
Facilities: Considerations Regarding
Access to Office Stock; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
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The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting
entitled ‘‘FDA’s Proposed Current Good
Manufacturing Practice Policies for
Outsourcing Facilities: Considerations
Regarding Access to Office Stock.’’
Stakeholders, including healthcare
providers (HCPs) and medical specialty
groups, have expressed concerns
regarding the availability of certain
compounded drug products from
outsourcing facilities that they would
like to have on-hand as in-office
supplies of non-patient-specific
compounded drugs (‘‘office stock’’). The
purpose of the public meeting is to
provide HCPs, outsourcing facilities,
entities considering becoming
outsourcing facilities, and other
interested parties with an opportunity to
present to FDA their perspectives
concerning access to office stock from
outsourcing facilities in light of FDA’s
enforcement policies as proposed in the
revised draft guidance on current good
manufacturing practice (CGMP) for
human drug compounding outsourcing
facilities.
SUMMARY:
The public meeting will be held
on May 21, 2019, from 9 a.m. to 5 p.m.
Submit either electronic or written
comments on this public meeting by
June 21, 2019. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
DATES:
The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before June 21, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 21, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
ADDRESSES:
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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 Docket No. FDA–2018–N–
4087 for ‘‘FDA’s Proposed Current Good
Manufacturing Practice Policies for
Outsourcing Facilities: Considerations
Regarding Access to Office Stock.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ are 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
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Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Bronwen Blass, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993–0002, 301–796–5092.
SUPPLEMENTARY INFORMATION:
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I. Background
A. Drug Compounding
Drug compounding is often regarded
as the process of combining, mixing, or
altering ingredients to create a
medication tailored to the needs of an
individual patient. Compounded drug
products serve an important role for
patients whose clinical needs cannot be
met by an FDA-approved drug product,
such as for a patient who has an allergy
to a certain dye contained in an FDAapproved drug product and needs a
medication compounded without that
dye, or an elderly patient or a child who
cannot swallow a pill and needs a
medicine in a liquid form that is not
available in an approved product. Drug
products can be compounded consistent
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with section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353a) by licensed pharmacists in
State-licensed pharmacies and Federal
facilities, or by licensed physicians, or
consistent with section 503B of the
FD&C Act (21 U.S.C. 353b) by
compounders known as outsourcing
facilities.
Sometimes, it is necessary for HCPs in
hospitals, clinics, offices, or other
settings to have a certain compounded
drug product on hand, so they can
administer it to a patient who presents
with an immediate need for the
compounded drug product. Such drug
products are often known as ‘‘office
stock,’’ and outsourcing facilities are
uniquely permitted to supply these
compounded products in accordance
with the law.
For example, if a patient presents at
an ophthalmologist’s office with a
fungal eye infection, timely
administration of a compounded
antifungal medication may be critical to
preventing vision loss. In such a case,
the ophthalmologist may need to inject
the patient with a compounded drug
product immediately, rather than
writing a prescription and waiting for
the drug product to be compounded and
shipped to the prescriber. In other cases,
compounded drug products may need to
be administered by a healthcare
practitioner in his or her office because
it would not be safe for the patient to
take the drug home for selfadministration, and it would be
preferable for the physician to have the
drug in his or her office to administer
immediately upon diagnosis, rather than
asking the physician to order the drug
and have the patient return to the
healthcare practitioner for
administration.
Although compounded drugs can
serve an important role for certain
patients in cases such as these, they also
can pose a higher risk to patients than
FDA-approved drugs. Compounded
drug products are not FDA-approved,
which means they have not undergone
FDA premarket review for safety,
effectiveness, and quality. Because
compounded drug products are subject
to a lower regulatory standard than
FDA-approved drug products, they
present a greater risk to patients and
should not be administered to patients
unless their medical needs cannot be
met by FDA-approved drug products.
B. Compounding Under the FD&C Act
Sections 503A and 503B of the FD&C
Act address human drug compounding.
Section 503A, added to the FD&C Act by
the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
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63649
115), describes the conditions that must
be satisfied for human drug products
compounded by a licensed pharmacist
in a State-licensed pharmacy or Federal
facility, or by a licensed physician, to be
exempt from the following three
sections of the FD&C Act:
• Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning CGMP
requirements);
• section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
drugs with adequate directions for use);
and
• section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications or abbreviated
new drug applications).
A compounded drug product may be
eligible for the exemptions under
section 503A of the FD&C Act only if it
is, among other things, compounded for
an identified individual patient based
on the receipt of a valid prescription
order or a notation, approved by the
prescribing practitioner, on the
prescription order that a compounded
product is necessary for the identified
patient. Among other conditions, to
qualify for the exemptions under section
503A, the drug product must be
compounded by a licensed pharmacist
in a State-licensed pharmacy or a
Federal facility, or by a licensed
physician (section 503A(a)).
New section 503B, added to the FD&C
Act by the Drug Quality and Security
Act in 2013, created a new category of
compounders called outsourcing
facilities. Section 503B defines
outsourcing facility, in part, as a facility
that is engaged in the compounding of
sterile drugs (section 503B(d)(4)(A)(i)).
An outsourcing facility may engage in
nonsterile compounding provided that
it also engages in the compounding of
sterile drugs, and provided that it
compounds all of its drugs (both sterile
and nonsterile) in accordance with the
conditions of section 503B.
Section 503B of the FD&C Act
describes the conditions that must be
satisfied for human drug products
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility to qualify for
exemptions from three sections of the
FD&C Act:
• Section 502(f)(1);
• section 505; and
• section 582 (21 U.S.C. 360eee–1)
(concerning drug supply chain security
requirements).
In contrast to compounders
compounding in accordance with
section 503A of the FD&C Act,
outsourcing facilities may, but need not,
obtain prescriptions for identified
individual patients for their
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compounded drug products (section
503B(d)(4)(C)). Outsourcing facilities are
subject to CGMP requirements in
section 501(a)(2)(B). They must also be
inspected by FDA according to a riskbased schedule and are subject to
specific adverse event reporting
requirements and other conditions that
help to mitigate the risks of the drug
products they compound.
C. CGMP Requirements for Outsourcing
Facilities
Elsewhere in this issue of the Federal
Register, FDA announced the
availability of a revised draft guidance
for industry entitled ‘‘Current Good
Manufacturing Practice—Guidance for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
FD&C Act.’’ (revised draft guidance).
FDA previously issued a draft guidance
for industry on this subject in July 2014
(79 FR 37743). This guidance, once
final, will provide for conditions under
which FDA generally does not intend to
take regulatory action against an
outsourcing facility regarding certain
CGMP requirements in 21 CFR parts 210
and 211 during the interim period
before FDA issues regulations specific to
outsourcing facilities. In developing
policies pertaining to CGMP
requirements for outsourcing facilities,
FDA seeks to recognize the differences
between outsourcing facilities and
conventional drug manufacturers and to
develop policies that reflect the specific
compounding operations conducted by
outsourcing facilities. The revised draft
guidance proposes a risk-based
approach to enforcement of CGMP
requirements, tailored to the size and
scope of outsourcing facilities’
operations. The policies are aimed at
making it more feasible for entities to
register as outsourcing facilities to
compound drugs for office stock in
accordance with CGMP requirements,
while maintaining the minimum
standards necessary to protect patients
from the risks of contaminated or
otherwise substandard drug products.
In the revised draft guidance, FDA
made a number of revisions to address
comments submitted on the 2014 draft.
For example, the revised draft guidance
differentiates between CGMP
requirements applicable to sterile drug
products and nonsterile drug products
where appropriate. Among other
changes, FDA made revisions to address
comments on (1) stability testing,
including the assignment of a beyond
use date (BUD) as an expiration date; (2)
a clear definition of ‘‘in-use time,’’
distinguishing it from ‘‘BUD’’ and
‘‘expiration date’’; (3) testing batches
before release for distribution; and (4)
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collection and use of samples retained
from distributed batches, known as
reserve samples. For a more
comprehensive discussion of the
policies proposed in the revised draft
guidance, please see the revised draft
guidance (available at: https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov) and associated
notice of availability, which FDA is
publishing elsewhere in this issue of the
Federal Register. In the docket for the
revised draft guidance, FDA is seeking
comment on whether the conditions
outlined appropriately balance the risks
and needs associated with compounded
drugs produced for office stock.
II. Topics for Discussion at the Public
Meeting
FDA is seeking public input regarding
outsourcing facilities supplying
compounded drugs for office stock in
light of the CGMP policies described in
the revised draft guidance, if finalized
as written. FDA has developed a list of
topics to facilitate a productive
discussion at the public meeting. This
list is not intended to be exhaustive, and
FDA encourages comments on the
potential implications of the policies
pertaining to compliance with CGMP
requirements described in the revised
draft CGMP guidance, if finalized as
written, for outsourcing facilities
supplying drugs compounded for office
stock. Policies include, but are not
limited to, those related to stability
studies, beyond use dating, and release
testing. Issues that are of specific
interest to the Agency include the
following:
• Perspectives related to demand and
supply of office stock, including:
Æ Ways in which HCPs seek to
identify outsourcing facilities that
compound the drugs they want for
office stock, as well as issues, if any,
with this process.
Æ Communications between HCPs
and outsourcing facilities to address
potential issues related to requested
formulations, timing, and order size.
Æ Coordination or consolidation of
orders among providers for same or
similar compounded drug products.
Æ HCPs’ experiences with the
availability of office stock products from
outsourcing facilities.
• Perspectives related to orders for
drug products that an outsourcing
facility has not made or does not
routinely make.
Æ Factors outsourcing facilities
consider before deciding whether to fill
an order for a requested compounded
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drug product that it has not previously
made or does not routinely make.
Æ The impact that FDA’s policies
proposed in the revised draft guidance
would have on outsourcing facilities
filling orders for requested products not
previously or routinely made.
• Perspectives related to small
volume orders of office stock products,
including:
Æ HCPs’ experiences seeking small
volume orders from outsourcing
facilities.
Æ Factors outsourcing facilities
consider before determining whether to
produce small batches of compounded
drug products for office stock.
Æ The impact that FDA’s policies
proposed in the revised draft guidance
would have on outsourcing facilities’
decisions regarding filling small volume
orders and/or producing small batches
of compounded drug products for office
stock.
Æ Whether/how the revisions
proposed in the revised draft guidance
would affect registration of
compounders engaged in smaller-scale
production as outsourcing facilities.
• Perspectives related to beyond use
dating for office stock products,
including:
Æ How long HCPs seek to keep office
stock drug products before use.
Æ The impact that FDA’s policies
proposed in the revised draft guidance
would have on outsourcing facilities’
production of compounded drug
products for office stock with beyond
use dating desired by HCPs.
FDA will post the agenda and other
meeting materials at least 5 days before
the meeting on the public meeting
website. More information regarding the
meeting, including the public meeting
website address, will be posted at:
https://www.fda.gov/Drugs/NewsEvents/
ucm132703.htm.
III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register online by May 7, 2019. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. More information regarding
the meeting, including the public
meeting website address and
registration instructions, will be posted
at: https://www.fda.gov/Drugs/
NewsEvents/ucm132703.htm.
Registration is free and in-person
attendance is based on space
availability, with priority given to early
registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
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organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8:30 a.m. We will post
information at https://www.fda.gov/
Drugs/NewsEvents/ucm132703.htm if
registration closes before the day of the
public meeting.
If you need special accommodations
due to a disability, please contact
CompoundingPublicMeeting@
fda.hhs.gov no later than May 14, 2019.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session and which
topic(s) you wish to address. All
requests to make oral presentations
must be received by March 1, 2019. You
will also be asked to send
CompoundingPublicMeeting@
fda.hhs.gov a brief summary your
comments by March 1, 2019.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to present.
For more information on oral
presentation requests, visit https://
www.fda.gov/Drugs/NewsEvents/ucm13
2703.htm. Following the close of
registration, we will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin. We
will do our best to accommodate all
stakeholders who wish to speak;
however, the duration of comments may
be limited by time constraints,
including time allowances for each
topic. Presenters will be notified of their
selection no later than May 7, 2019. If
selected for presentation, any
presentation materials must be emailed
to the CompoundingPublicMeeting@
fda.hhs.gov no later than May 14, 2019.
No commercial or promotional material
will be permitted to be presented or
distributed at the public meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Further information
regarding the webcast, including the
address for the webcast, will be made
available at least 2 days in advance of
the meeting on the public meeting
website. More information regarding the
meeting, including the public meeting
website address, will be posted at:
https://www.fda.gov/Drugs/NewsEvents/
ucm132703.htm. FDA has verified the
website addresses in this document, as
of the date this document publishes in
the Federal Register, but websites are
subject to change over time.
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Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26725 Filed 12–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0779]
Current Good Manufacturing
Practice—Guidance for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the FD&C Act;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a revised
draft guidance entitled ‘‘Current Good
Manufacturing Practice—Guidance for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
FD&C Act.’’ This revised draft guidance
describes FDA’s policies regarding
compounders registered under section
503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as outsourcing
facilities and the current good
manufacturing practice (CGMP)
requirements in FDA regulations. Based
on feedback from stakeholders and
comments received on the initial draft
guidance, the guidance is being revised,
in part, to reflect further consideration
of how CGMP requirements should be
applied in light of the size and scope of
an outsourcing facility’s operations.
DATES: Submit either electronic or
written comments on the revised draft
guidance by February 11, 2019 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 concerning the
collection of information under the
Paperwork Reduction Act of 1995 (PRA)
proposed in the revised draft guidance
by February 11, 2019.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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://
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63651
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–
2014–D–0779 for ‘‘Current Good
Manufacturing Practice—Guidance for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
FD&C Act.’’ 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.
• 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
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]]>Agencies
[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63648-63651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26725]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4087]
The Food and Drug Administration's Proposed Current Good
Manufacturing Practice Policies for Outsourcing Facilities:
Considerations Regarding Access to Office Stock; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``FDA's Proposed Current Good
Manufacturing Practice Policies for Outsourcing Facilities:
Considerations Regarding Access to Office Stock.'' Stakeholders,
including healthcare providers (HCPs) and medical specialty groups,
have expressed concerns regarding the availability of certain
compounded drug products from outsourcing facilities that they would
like to have on-hand as in-office supplies of non-patient-specific
compounded drugs (``office stock''). The purpose of the public meeting
is to provide HCPs, outsourcing facilities, entities considering
becoming outsourcing facilities, and other interested parties with an
opportunity to present to FDA their perspectives concerning access to
office stock from outsourcing facilities in light of FDA's enforcement
policies as proposed in the revised draft guidance on current good
manufacturing practice (CGMP) for human drug compounding outsourcing
facilities.
DATES: The public meeting will be held on May 21, 2019, from 9 a.m. to
5 p.m. Submit either electronic or written comments on this public
meeting by June 21, 2019. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 21, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 21, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
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 Docket No. FDA-
2018-N-4087 for ``FDA's Proposed Current Good Manufacturing Practice
Policies for Outsourcing Facilities: Considerations Regarding Access to
Office Stock.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' are 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
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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.gpo.gov/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.
FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-5092.
SUPPLEMENTARY INFORMATION:
I. Background
A. Drug Compounding
Drug compounding is often regarded as the process of combining,
mixing, or altering ingredients to create a medication tailored to the
needs of an individual patient. Compounded drug products serve an
important role for patients whose clinical needs cannot be met by an
FDA-approved drug product, such as for a patient who has an allergy to
a certain dye contained in an FDA-approved drug product and needs a
medication compounded without that dye, or an elderly patient or a
child who cannot swallow a pill and needs a medicine in a liquid form
that is not available in an approved product. Drug products can be
compounded consistent with section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) by licensed pharmacists in
State-licensed pharmacies and Federal facilities, or by licensed
physicians, or consistent with section 503B of the FD&C Act (21 U.S.C.
353b) by compounders known as outsourcing facilities.
Sometimes, it is necessary for HCPs in hospitals, clinics, offices,
or other settings to have a certain compounded drug product on hand, so
they can administer it to a patient who presents with an immediate need
for the compounded drug product. Such drug products are often known as
``office stock,'' and outsourcing facilities are uniquely permitted to
supply these compounded products in accordance with the law.
For example, if a patient presents at an ophthalmologist's office
with a fungal eye infection, timely administration of a compounded
antifungal medication may be critical to preventing vision loss. In
such a case, the ophthalmologist may need to inject the patient with a
compounded drug product immediately, rather than writing a prescription
and waiting for the drug product to be compounded and shipped to the
prescriber. In other cases, compounded drug products may need to be
administered by a healthcare practitioner in his or her office because
it would not be safe for the patient to take the drug home for self-
administration, and it would be preferable for the physician to have
the drug in his or her office to administer immediately upon diagnosis,
rather than asking the physician to order the drug and have the patient
return to the healthcare practitioner for administration.
Although compounded drugs can serve an important role for certain
patients in cases such as these, they also can pose a higher risk to
patients than FDA-approved drugs. Compounded drug products are not FDA-
approved, which means they have not undergone FDA premarket review for
safety, effectiveness, and quality. Because compounded drug products
are subject to a lower regulatory standard than FDA-approved drug
products, they present a greater risk to patients and should not be
administered to patients unless their medical needs cannot be met by
FDA-approved drug products.
B. Compounding Under the FD&C Act
Sections 503A and 503B of the FD&C Act address human drug
compounding. Section 503A, added to the FD&C Act by the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115), describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist in a State-licensed pharmacy or
Federal facility, or by a licensed physician, to be exempt from the
following three sections of the FD&C Act:
Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
CGMP requirements);
section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate directions for use); and
section 505 (21 U.S.C. 355) (concerning the approval of
drugs under new drug applications or abbreviated new drug
applications).
A compounded drug product may be eligible for the exemptions under
section 503A of the FD&C Act only if it is, among other things,
compounded for an identified individual patient based on the receipt of
a valid prescription order or a notation, approved by the prescribing
practitioner, on the prescription order that a compounded product is
necessary for the identified patient. Among other conditions, to
qualify for the exemptions under section 503A, the drug product must be
compounded by a licensed pharmacist in a State-licensed pharmacy or a
Federal facility, or by a licensed physician (section 503A(a)).
New section 503B, added to the FD&C Act by the Drug Quality and
Security Act in 2013, created a new category of compounders called
outsourcing facilities. Section 503B defines outsourcing facility, in
part, as a facility that is engaged in the compounding of sterile drugs
(section 503B(d)(4)(A)(i)). An outsourcing facility may engage in
nonsterile compounding provided that it also engages in the compounding
of sterile drugs, and provided that it compounds all of its drugs (both
sterile and nonsterile) in accordance with the conditions of section
503B.
Section 503B of the FD&C Act describes the conditions that must be
satisfied for human drug products compounded by or under the direct
supervision of a licensed pharmacist in an outsourcing facility to
qualify for exemptions from three sections of the FD&C Act:
Section 502(f)(1);
section 505; and
section 582 (21 U.S.C. 360eee-1) (concerning drug supply
chain security requirements).
In contrast to compounders compounding in accordance with section
503A of the FD&C Act, outsourcing facilities may, but need not, obtain
prescriptions for identified individual patients for their
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compounded drug products (section 503B(d)(4)(C)). Outsourcing
facilities are subject to CGMP requirements in section 501(a)(2)(B).
They must also be inspected by FDA according to a risk-based schedule
and are subject to specific adverse event reporting requirements and
other conditions that help to mitigate the risks of the drug products
they compound.
C. CGMP Requirements for Outsourcing Facilities
Elsewhere in this issue of the Federal Register, FDA announced the
availability of a revised draft guidance for industry entitled
``Current Good Manufacturing Practice--Guidance for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the FD&C
Act.'' (revised draft guidance). FDA previously issued a draft guidance
for industry on this subject in July 2014 (79 FR 37743). This guidance,
once final, will provide for conditions under which FDA generally does
not intend to take regulatory action against an outsourcing facility
regarding certain CGMP requirements in 21 CFR parts 210 and 211 during
the interim period before FDA issues regulations specific to
outsourcing facilities. In developing policies pertaining to CGMP
requirements for outsourcing facilities, FDA seeks to recognize the
differences between outsourcing facilities and conventional drug
manufacturers and to develop policies that reflect the specific
compounding operations conducted by outsourcing facilities. The revised
draft guidance proposes a risk-based approach to enforcement of CGMP
requirements, tailored to the size and scope of outsourcing facilities'
operations. The policies are aimed at making it more feasible for
entities to register as outsourcing facilities to compound drugs for
office stock in accordance with CGMP requirements, while maintaining
the minimum standards necessary to protect patients from the risks of
contaminated or otherwise substandard drug products.
In the revised draft guidance, FDA made a number of revisions to
address comments submitted on the 2014 draft. For example, the revised
draft guidance differentiates between CGMP requirements applicable to
sterile drug products and nonsterile drug products where appropriate.
Among other changes, FDA made revisions to address comments on (1)
stability testing, including the assignment of a beyond use date (BUD)
as an expiration date; (2) a clear definition of ``in-use time,''
distinguishing it from ``BUD'' and ``expiration date''; (3) testing
batches before release for distribution; and (4) collection and use of
samples retained from distributed batches, known as reserve samples.
For a more comprehensive discussion of the policies proposed in the
revised draft guidance, please see the revised draft guidance
(available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov) and associated notice of availability,
which FDA is publishing elsewhere in this issue of the Federal
Register. In the docket for the revised draft guidance, FDA is seeking
comment on whether the conditions outlined appropriately balance the
risks and needs associated with compounded drugs produced for office
stock.
II. Topics for Discussion at the Public Meeting
FDA is seeking public input regarding outsourcing facilities
supplying compounded drugs for office stock in light of the CGMP
policies described in the revised draft guidance, if finalized as
written. FDA has developed a list of topics to facilitate a productive
discussion at the public meeting. This list is not intended to be
exhaustive, and FDA encourages comments on the potential implications
of the policies pertaining to compliance with CGMP requirements
described in the revised draft CGMP guidance, if finalized as written,
for outsourcing facilities supplying drugs compounded for office stock.
Policies include, but are not limited to, those related to stability
studies, beyond use dating, and release testing. Issues that are of
specific interest to the Agency include the following:
Perspectives related to demand and supply of office stock,
including:
[cir] Ways in which HCPs seek to identify outsourcing facilities
that compound the drugs they want for office stock, as well as issues,
if any, with this process.
[cir] Communications between HCPs and outsourcing facilities to
address potential issues related to requested formulations, timing, and
order size.
[cir] Coordination or consolidation of orders among providers for
same or similar compounded drug products.
[cir] HCPs' experiences with the availability of office stock
products from outsourcing facilities.
Perspectives related to orders for drug products that an
outsourcing facility has not made or does not routinely make.
[cir] Factors outsourcing facilities consider before deciding
whether to fill an order for a requested compounded drug product that
it has not previously made or does not routinely make.
[cir] The impact that FDA's policies proposed in the revised draft
guidance would have on outsourcing facilities filling orders for
requested products not previously or routinely made.
Perspectives related to small volume orders of office
stock products, including:
[cir] HCPs' experiences seeking small volume orders from
outsourcing facilities.
[cir] Factors outsourcing facilities consider before determining
whether to produce small batches of compounded drug products for office
stock.
[cir] The impact that FDA's policies proposed in the revised draft
guidance would have on outsourcing facilities' decisions regarding
filling small volume orders and/or producing small batches of
compounded drug products for office stock.
[cir] Whether/how the revisions proposed in the revised draft
guidance would affect registration of compounders engaged in smaller-
scale production as outsourcing facilities.
Perspectives related to beyond use dating for office stock
products, including:
[cir] How long HCPs seek to keep office stock drug products before
use.
[cir] The impact that FDA's policies proposed in the revised draft
guidance would have on outsourcing facilities' production of compounded
drug products for office stock with beyond use dating desired by HCPs.
FDA will post the agenda and other meeting materials at least 5
days before the meeting on the public meeting website. More information
regarding the meeting, including the public meeting website address,
will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by May 7, 2019. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone. More information regarding the meeting,
including the public meeting website address and registration
instructions, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.
Registration is free and in-person attendance is based on space
availability, with priority given to early registrants. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each
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organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public meeting will be provided beginning at 8:30 a.m. We will post
information at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm if
registration closes before the day of the public meeting.
If you need special accommodations due to a disability, please
contact [email protected] no later than May 14,
2019.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. All requests to make oral
presentations must be received by March 1, 2019. You will also be asked
to send [email protected] a brief summary your
comments by March 1, 2019. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to present. For more information on oral
presentation requests, visit https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm. Following the close of registration, we will determine
the amount of time allotted to each presenter and the approximate time
each oral presentation is to begin. We will do our best to accommodate
all stakeholders who wish to speak; however, the duration of comments
may be limited by time constraints, including time allowances for each
topic. Presenters will be notified of their selection no later than May
7, 2019. If selected for presentation, any presentation materials must
be emailed to the [email protected] no later than
May 14, 2019. No commercial or promotional material will be permitted
to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Further information regarding the webcast, including
the address for the webcast, will be made available at least 2 days in
advance of the meeting on the public meeting website. More information
regarding the meeting, including the public meeting website address,
will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.
FDA has verified the website addresses in this document, as of the date
this document publishes in the Federal Register, but websites are
subject to change over time.
Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26725 Filed 12-10-18; 8:45 am]
BILLING CODE 4164-01-P
