Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability, 44881-44883 [2016-16361]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
44881
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Type of reporting
Consultation between the outsourcing facility and prescriber or health care facility, and the notation on the
prescription or order documenting the prescriber’s determination of clinical difference.
Checking FDA’s drug shortage list and documenting on
the prescription that the drug is in shortage.
1 There
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16362 Filed 7–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1309]
Compounded Drug Products That Are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for
Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Compounded Drug Products That Are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ To qualify for
exemptions under section 503A of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), a drug product must be
compounded by a licensed pharmacist
or physician who does not compound
regularly or in inordinate amounts any
drug products that are essentially copies
of a commercially available drug
product. This guidance sets forth FDA
policies regarding this provision of
SUMMARY:
sradovich on DSK3GDR082PROD with NOTICES
Total annual
disclosures
Average
burden per
disclosure
Total hours
40
100
4,000
3 minutes .......
200
30
100
3,000
2 minutes .......
100
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
AGENCY:
Number of
disclosures
per
respondent
VerDate Sep<11>2014
16:55 Jul 08, 2016
Jkt 238001
section 503A, including the terms
‘‘commercially available,’’ ‘‘essentially a
copy of a commercially available drug,’’
and ‘‘regularly or in inordinate
amounts.’’
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 to
finalize the guidance, submit either
electronic or written comments on this
draft guidance by October 11, 2016.
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:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–1309 for ‘‘Compounded Drug
Products That Are Essentially Copies of
a Commercially Available Drug Product
Under Section 503A of the Federal
Food, Drug, and Cosmetic 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
Division of Dockets Management
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
E:\FR\FM\11JYN1.SGM
11JYN1
44882
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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. 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: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD, 301–796–3110.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GDR082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Compounded Drug Products That Are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ Section 503A (21 U.S.C.
353a), added to the FD&C Act by the
Food and Drug Administration
Modernization Act in 1997, 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 current good
manufacturing practice requirements);
• section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of
VerDate Sep<11>2014
16:55 Jul 08, 2016
Jkt 238001
drugs with adequate directions for use);
and
• section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)).
One of the conditions that must be
met for a compounded drug product to
qualify for the exemptions under section
503A of the FD&C Act is that it must be
compounded by a licensed pharmacist
or a licensed physician that does not
compound regularly or in inordinate
amounts (as defined by the Secretary)
any drug products that are essentially
copies of a commercially available drug
product (see section 503A(b)(1)(D)).
The statute further states that the term
‘‘essentially a copy of a commercially
available drug product’’ does not
include a drug product in which there
is a change, made for an identified
individual patient, which produces for
that patient a significant difference, as
determined by the prescribing
practitioner, between the compounded
drug and the comparable commercially
available drug (see section 503A(b)(2)).
This draft guidance sets forth the
FDA’s proposed policies regarding this
provision of section 503A, including the
terms ‘‘commercially available,’’
‘‘essentially a copy of a commercially
available drug,’’ and ‘‘regularly or in
inordinate amounts.’’
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 the compounded drug products that
are essentially copies of a commercially
available drug product under section
503A of the FD&C Act. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this
document, FDA invites comments on
the following topics: (1) Whether the
proposed collection of information is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the draft guidance, pursuant to
section 503A(b)(2) of the FD&C Act, a
compounded drug product is not
essentially a copy of a commercially
available drug product if a change is
made for an identified individual
patient, and the prescribing practitioner
has determined that the change will
produce a significant difference for that
patient. If a compounder intends to rely
on such a determination to establish
that a compounded drug is not
essentially a copy of a commercially
available drug product, the compounder
should ensure that the determination is
documented on a prescription.
If a prescription does not make clear
that the prescriber made the
determination required by section
503A(b)(2), or a compounded drug is
substituted for the commercially
available product at the pharmacy, the
compounder may contact the prescriber
and if the prescriber confirms it, make
a notation on the prescription that the
compounded product contains a change
that makes a significant difference for
the patient. The notations should be as
specific as those described in this
document, and the date of the
conversation with the prescriber should
be included on the prescription.
We estimate that annually a total of
approximately 3,444 compounders
(‘‘number of respondents’’ in table 1,
line 1) will consult a prescriber to
determine whether he or she has made
a determination that the compounded
drug has a change that produces a
significant difference for a patient as
compared to the comparable
commercially available drug, and that
the compounders will document this
determination on approximately
E:\FR\FM\11JYN1.SGM
11JYN1
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
172,200 prescription orders for
compounded drugs (‘‘total annual
disclosures’’ in table 1, line 1). We
estimate that the consultation between
the compounder and the prescriber and
adding a notation to each prescription
that does not already document this
determination will take approximately 3
minutes per prescription order.
In addition, if the drug was
compounded because the approved
product was not commercially available
because it was on the FDA drug shortage
list, the prescription or a notation on the
prescription should note that it was on
the drug shortage list and the date the
list was checked. We estimate that a
total of approximately 6,888
compounders (‘‘number of respondents’’
in table 1, line 2) will document this
information on approximately 344,400
prescription orders for compounded
drugs (‘‘total annual disclosures’’ in
table 1, line 2). We estimate that
checking FDA’s drug shortage list and
documenting this information will take
approximately 2 minutes per
prescription order.
Compounders under section 503A
should maintain records of the
frequency in which they have
compounded drug products that are
essentially copies of commercially
available drug products and the number
of prescriptions that they have filled for
compounded drug products that are
essentially copies of commercially
available drug products to document
that such compounding has not been
done ‘‘regularly’’ or in ‘‘inordinate
amounts.’’ We estimate that a total of
approximately 3,444 compounders
(‘‘number of recordkeepers’’ in table 1)
will keep approximately 165,312
records (‘‘total annual records’’). We
estimate that maintaining the records
will take approximately 2 minutes per
record.
A licensed pharmacist or physician
seeking to compound a drug product
44883
under section 503A should also
maintain records of prescriptions for
identified individual patients including
notations that a prescriber has
determined that the compounded drug
has a change that produces a significant
difference for the identified patient.
Because the time, effort, and financial
resources necessary to comply with this
collection of information would be
incurred by licensed pharmacists and
licensed physicians in the normal
course of their activities, it is excluded
from the definition of ‘‘burden’’ under 5
CFR 1320.3(b)(2). FDA understands that
maintaining records of prescriptions for
compounded drug products is part of
the usual course of the practice of
compounding and selling drugs and is
required by States’ pharmacy laws and
other state laws governing
recordkeeping by health care
professionals and health care facilities.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Type of reporting
Consultation between the compounder and prescriber and
the notation on the prescription documenting the prescriber’s determination of significant difference.
Checking FDA’s drug shortage list and documenting on
the prescription that the drug is in shortage.
1 There
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
6,888
50
344,400
3 minutes .......
17,220
6,888
50
344,400
2 minutes .......
11,480
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of recordkeeping
Records of frequency and number of prescriptions filled
for compounded drugs that are essentially a copy.
1 There
3,444
48
Total annual
records
165,312
Average
burden per
recordkeeping
2 minutes .......
Total hours
5,510
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
sradovich on DSK3GDR082PROD with NOTICES
Number of
records per
recordkeeper
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16361 Filed 7–8–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1673]
Updating Abbreviated New Drug
Application Labeling After the
Marketing Application for the
Reference Listed Drug Has Been
Withdrawn; Draft Guidance for
Industry; Availability
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:55 Jul 08, 2016
Jkt 238001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
announcing the availability of a draft
guidance for industry entitled
‘‘Updating ANDA Labeling After the
Marketing Application for the Reference
Listed Drug Has Been Withdrawn.’’ This
draft guidance describes a process for
updating labeling for abbreviated new
drug applications (ANDAs) in cases
where FDA has withdrawn approval of
the new drug application (NDA) for the
ANDA’s reference listed drug (RLD) for
reasons other than safety or
effectiveness. The process described in
this guidance is intended to
complement existing Agency authorities
and processes.
Although you can comment on
any guidance at any time (see 21 CFR
DATES:
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44881-44883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1309]
Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' To qualify for exemptions under section
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug
product must be compounded by a licensed pharmacist or physician who
does not compound regularly or in inordinate amounts any drug products
that are essentially copies of a commercially available drug product.
This guidance sets forth FDA policies regarding this provision of
section 503A, including the terms ``commercially available,''
``essentially a copy of a commercially available drug,'' and
``regularly or in inordinate amounts.''
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 to finalize the guidance, submit
either electronic or written comments on this draft guidance by October
11, 2016.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1309 for ``Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic 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 Division of Dockets Management 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 Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can
[[Page 44882]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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. 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: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD, 301-796-3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), added to
the FD&C Act by the Food and Drug Administration Modernization Act in
1997, 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
current good manufacturing practice 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 (NDAs) or abbreviated new drug
applications (ANDAs)).
One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503A of the FD&C
Act is that it must be compounded by a licensed pharmacist or a
licensed physician that does not compound regularly or in inordinate
amounts (as defined by the Secretary) any drug products that are
essentially copies of a commercially available drug product (see
section 503A(b)(1)(D)).
The statute further states that the term ``essentially a copy of a
commercially available drug product'' does not include a drug product
in which there is a change, made for an identified individual patient,
which produces for that patient a significant difference, as determined
by the prescribing practitioner, between the compounded drug and the
comparable commercially available drug (see section 503A(b)(2)).
This draft guidance sets forth the FDA's proposed policies
regarding this provision of section 503A, including the terms
``commercially available,'' ``essentially a copy of a commercially
available drug,'' and ``regularly or in inordinate amounts.''
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 the compounded
drug products that are essentially copies of a commercially available
drug product under section 503A of the FD&C Act. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Under the draft guidance, pursuant to section 503A(b)(2) of the
FD&C Act, a compounded drug product is not essentially a copy of a
commercially available drug product if a change is made for an
identified individual patient, and the prescribing practitioner has
determined that the change will produce a significant difference for
that patient. If a compounder intends to rely on such a determination
to establish that a compounded drug is not essentially a copy of a
commercially available drug product, the compounder should ensure that
the determination is documented on a prescription.
If a prescription does not make clear that the prescriber made the
determination required by section 503A(b)(2), or a compounded drug is
substituted for the commercially available product at the pharmacy, the
compounder may contact the prescriber and if the prescriber confirms
it, make a notation on the prescription that the compounded product
contains a change that makes a significant difference for the patient.
The notations should be as specific as those described in this
document, and the date of the conversation with the prescriber should
be included on the prescription.
We estimate that annually a total of approximately 3,444
compounders (``number of respondents'' in table 1, line 1) will consult
a prescriber to determine whether he or she has made a determination
that the compounded drug has a change that produces a significant
difference for a patient as compared to the comparable commercially
available drug, and that the compounders will document this
determination on approximately
[[Page 44883]]
172,200 prescription orders for compounded drugs (``total annual
disclosures'' in table 1, line 1). We estimate that the consultation
between the compounder and the prescriber and adding a notation to each
prescription that does not already document this determination will
take approximately 3 minutes per prescription order.
In addition, if the drug was compounded because the approved
product was not commercially available because it was on the FDA drug
shortage list, the prescription or a notation on the prescription
should note that it was on the drug shortage list and the date the list
was checked. We estimate that a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 2) will
document this information on approximately 344,400 prescription orders
for compounded drugs (``total annual disclosures'' in table 1, line 2).
We estimate that checking FDA's drug shortage list and documenting this
information will take approximately 2 minutes per prescription order.
Compounders under section 503A should maintain records of the
frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products to document that such compounding has not been done
``regularly'' or in ``inordinate amounts.'' We estimate that a total of
approximately 3,444 compounders (``number of recordkeepers'' in table
1) will keep approximately 165,312 records (``total annual records'').
We estimate that maintaining the records will take approximately 2
minutes per record.
A licensed pharmacist or physician seeking to compound a drug
product under section 503A should also maintain records of
prescriptions for identified individual patients including notations
that a prescriber has determined that the compounded drug has a change
that produces a significant difference for the identified patient.
Because the time, effort, and financial resources necessary to comply
with this collection of information would be incurred by licensed
pharmacists and licensed physicians in the normal course of their
activities, it is excluded from the definition of ``burden'' under 5
CFR 1320.3(b)(2). FDA understands that maintaining records of
prescriptions for compounded drug products is part of the usual course
of the practice of compounding and selling drugs and is required by
States' pharmacy laws and other state laws governing recordkeeping by
health care professionals and health care facilities.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of disclosures Total annual Average burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Consultation between the 6,888 50 344,400 3 minutes......... 17,220
compounder and prescriber
and the notation on the
prescription documenting
the prescriber's
determination of
significant difference.
Checking FDA's drug shortage 6,888 50 344,400 2 minutes......... 11,480
list and documenting on the
prescription that the drug
is in shortage.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of recordkeeping Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of frequency and 3,444 48 165,312 2 minutes......... 5,510
number of prescriptions
filled for compounded drugs
that are essentially a copy.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16361 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P
