81 FR 37500 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 112 (June 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37500-37502 | |
| FR Document | 2016-13798 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Rules and Regulations] [Pages 37500-37502] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13798] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2015-D-3539] Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 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 guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 [[Page 37501]] 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-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B 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 http://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 http://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 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: http://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 http://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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' A new section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug Quality and Security Act in 2013, describes the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility does not compound drug products using a bulk drug substance unless: It appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (see section 503B(a)(2)(A)(i) of the FD&C Act); or the drug compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act). This guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product from a bulk drug substance that does not appear on a list of bulk drug substances that can be used in compounding and is not used to compound a drug product that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding pursuant to section 503B(a)(2)(A)(i) of the FD&C Act (503B bulks list).\1\ --------------------------------------------------------------------------- \1\ Elsewhere in this issue of the Federal Register, the Agency is making available a guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act,'' which describes the conditions under which FDA does not intend to take action against a licensed pharmacist in a State-licensed pharmacy or Federal facility, or a licensed physician, for compounding a drug product from a bulk drug substance that cannot otherwise be used in compounding under section 503A of the FD&C Act while FDA develops the list of bulk drug substances that can be used in compounding under section 503A(b)(1)(A)(i)(III). --------------------------------------------------------------------------- The guidance also describes FDA's process to establish the 503B bulks list, and it describes categories of substances that were nominated for inclusion on the 503B bulks list. These categories include: 503B Category 1--Bulk Drug Substances Under Evaluation: These bulk drug substances may be eligible for inclusion on the 503B bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list. 503B Category 2--Bulk Drug Substances That Raise Significant Safety Risks: These bulk drug substances were nominated with sufficient supporting information to permit FDA to evaluate them and they may be eligible for inclusion on the 503B bulks list. However, FDA has identified significant safety risks relating to the use of these bulk substances in compounding, and therefore does not intend to adopt the policy described for the bulk substances in Category 1. 503B Category 3--Bulk Drug Substances Nominated Without Adequate Support: These bulk drug substances may be eligible for inclusion on the 503B bulks list but were nominated with insufficient supporting information for FDA to evaluate them. These substances can be re-nominated with sufficient supporting information [[Page 37502]] through a docket that FDA has established. In the Federal Register of October 27, 2015 (80 FR 65768), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on December 28, 2015. FDA received 11 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes to the guidance to clarify particular points. In addition, FDA has made the following updates to the lists on its Web site of bulk drug substances that were nominated for inclusion on the 503A bulks list: \2\ --------------------------------------------------------------------------- \2\ In the future, if FDA makes changes to the categories of bulk drug substances on its Web site, we intend to follow the procedure identified in the guidance. --------------------------------------------------------------------------- 503B Category 2: FDA has added one bulk drug substances to Category 2, germanium sesquioxide, because FDA identified significant safety risks relating to the use of this bulk drug substance in compounding. 503B Category 4: The draft interim guidance included a fourth category of bulk drug substances that would have identified substances that FDA evaluated for inclusion on the 503B bulks list but, after obtaining and considering public comments, decided not to place on the 503B bulks list. In the final interim guidance, FDA removed this fourth category because the Agency intends to identify the bulk drug substances that will not be placed on the 503B bulks list in the Federal Register notice that establishes the 503B bulks list. Therefore, we do not believe it is necessary to also include them in the categories identified in this guidance. II. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13798 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
![37500 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
is codifying the classification of the collections of information are subject to DEPARTMENT OF HEALTH AND
device by adding 21 CFR 886.5838. review by the Office of Management and HUMAN SERVICES
The device is assigned the generic Budget (OMB) under the Paperwork
name nasolacrimal compression device, Reduction Act of 1995 (44 U.S.C. 3501– Food and Drug Administration
and it is identified as a prescription 3520). The collections of information in
device that is fitted to apply mechanical part 807, subpart E, regarding premarket 21 CFR Chapter I
pressure to the nasal aspect of the notification submissions, have been [Docket No. FDA–2015–D–3539]
orbital rim to reduce outflow through approved under OMB control number
the nasolacrimal ducts. 0910–0120; the collections of Interim Policy on Compounding Using
The risks to health that may be information in 21 CFR part 820, Bulk Drug Substances Under Section
associated with use of the nasolacrimal regarding the quality system regulation, 503B of the Federal Food, Drug, and
compression device are improper fit of have been approved under OMB control Cosmetic Act; Guidance for Industry;
the device (extended or aggressive use number 0910–0073; and the collections Availability
of this device may cause sequelae such of information in 21 CFR part 801,
as bruising and/or soreness) and regarding labeling, have been approved AGENCY: Food and Drug Administration,
improper use of the device (for the under OMB control number 0910–0485. HHS.
uncoordinated, a corneal abrasion may ACTION: Notice of availability.
occur inadvertently). General controls of IV. Reference
the FD&C Act, including compliance SUMMARY: The Food and Drug
The following reference is on display Administration (FDA or the Agency) is
with the labeling requirements in 21 in the Division of Dockets Management
CFR part 801 and the Quality System announcing the availability of a
(HFA–305), Food and Drug guidance for industry entitled ‘‘Interim
Regulation (21 CFR part 820), are Administration, 5630 Fishers Lane, Rm.
sufficient to mitigate these risks and Policy on Compounding Using Bulk
1061, Rockville, MD 20852, and is Drug Substances Under Section 503B of
reasonably assure safety and available for viewing by interested
effectiveness. FDA believes that the the Federal Food, Drug, and Cosmetic
persons between 9 a.m. and 4 p.m., Act.’’ The guidance describes FDA’s
general controls provide reasonable Monday through Friday; it is also
assurance of safety and effectiveness. interim regulatory policy regarding
available electronically at http:// outsourcing facilities that compound
The nasolacrimal compression device www.regulations.gov.
is not safe for use except under the human drug products using bulk drug
supervision of a practitioner licensed by 1. DEN140022: De novo request from substances while FDA develops the list
Innovatex, Inc., dated June 27, 2014. of bulk drug substances that can be used
law to direct the use of the device. As
such, the device is a prescription device List of Subjects in 21 CFR Part 886 in compounding under the Federal
and must satisfy prescription labeling Food, Drug, and Cosmetic Act (the
Medical devices, Ophthalmic goods FD&C Act).
requirements (see 21 CFR 801.109, and services.
Prescription devices). DATES: Submit electronic or written
Section 510(l) of the FD&C Act Therefore, under the Federal Food, comments on Agency guidances at any
provides that a class I device is not Drug, and Cosmetic Act and under time.
subject to the premarket notification authority delegated to the Commissioner ADDRESSES: You may submit comments
requirements under section 510(k) of the of Food and Drugs, 21 CFR part 886 is as follows:
FD&C Act, unless the device is of amended as follows:
Electronic Submissions
substantial importance in preventing
impairment of human health or presents PART 886—OPHTHALMIC DEVICES Submit electronic comments in the
a potential unreasonable risk of illness following way:
■ 1. The authority citation for 21 CFR • Federal eRulemaking Portal: http://
or injury. FDA has determined that the part 886 continues to read as follows:
device does meet these criteria and, www.regulations.gov. Follow the
therefore, premarket notification is not Authority: 21 U.S.C. 351, 360, 360c, 360e, instructions for submitting comments.
required for the device. Thus, persons 360j, 371. Comments submitted electronically,
who intend to market this device need ■ 2. Add § 886.5838 to subpart F to read including attachments, to http://
not submit a premarket notification as follows: www.regulations.gov will be posted to
containing information on the the docket unchanged. Because your
nasolacrimal compression device they § 886.5838 Nasolacrimal compression comment will be made public, you are
intend to market prior to marketing the device. solely responsible for ensuring that your
device, subject to the limitations on (a) Identification. A nasolacrimal comment does not include any
exemptions in 21 CFR 886.9. compression device is a prescription confidential information that you or a
device that is fitted to apply mechanical third party may not wish to be posted,
II. Analysis of Environmental Impact pressure to the nasal aspect of the such as medical information, your or
The Agency has determined under 21 orbital rim to reduce outflow through anyone else’s Social Security number, or
CFR 25.34(b) that this action is of a type the nasolacrimal ducts. confidential business information, such
that does not individually or (b) Classification. Class I (general as a manufacturing process. Please note
cumulatively have a significant effect on controls). The device is exempt from the that if you include your name, contact
the human environment. Therefore, premarket notification procedures in information, or other information that
asabaliauskas on DSK3SPTVN1PROD with RULES
neither an environmental assessment subpart E of part 807 of this chapter, identifies you in the body of your
nor an environmental impact statement subject to the limitations in § 886.9. comments, that information will be
is required. posted on http://www.regulations.gov.
Dated: June 6, 2016. • If you want to submit a comment
III. Paperwork Reduction Act of 1995 Leslie Kux, with confidential information that you
This final order refers to previously Associate Commissioner for Policy. do not wish to be made available to the
approved collections of information [FR Doc. 2016–13788 Filed 6–9–16; 8:45 am] public, submit the comment as a
found in other FDA regulations. These BILLING CODE 4164–01–P written/paper submission and in the
VerDate Sep<11>2014 16:32 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\10JNR1.SGM 10JNR1](https://thefederalregister.org/doc/81_FR_37612/page/1.svg)
![37502 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Rules and Regulations
through a docket that FDA has DEPARTMENT OF HEALTH AND public, submit the comment as a
established. HUMAN SERVICES written/paper submission and in the
In the Federal Register of October 27, manner detailed (see ‘‘Written/Paper
Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
2015 (80 FR 65768), FDA issued a notice
announcing the availability of the draft 21 CFR Chapter I Written/Paper Submissions
version of this guidance. The comment Submit written/paper submissions as
period on the draft guidance ended on [Docket No. FDA–2015–D–3517]
follows:
December 28, 2015. FDA received 11
Interim Policy on Compounding Using • Mail/Hand delivery/Courier (for
comments on the draft guidance. In written/paper submissions): Division of
Bulk Drug Substances Under Section
response to received comments or on its 503A of the Federal Food, Drug, and Dockets Management (HFA–305), Food
own initiative, FDA made several Cosmetic Act; Guidance for Industry; and Drug Administration, 5630 Fishers
changes to the guidance to clarify Availability. Lane, Rm. 1061, Rockville, MD 20852.
particular points. In addition, FDA has • For written/paper comments
made the following updates to the lists AGENCY: Food and Drug Administration, submitted to the Division of Dockets
on its Web site of bulk drug substances HHS. Management, FDA will post your
that were nominated for inclusion on ACTION: Notice of availability. comment, as well as any attachments,
the 503A bulks list: 2 except for information submitted,
SUMMARY: The Food and Drug marked and identified, as confidential,
• 503B Category 2: FDA has added Administration (FDA or Agency) is if submitted as detailed in
one bulk drug substances to Category 2, announcing the availability of a ‘‘Instructions.’’
germanium sesquioxide, because FDA guidance for industry entitled ‘‘Interim Instructions: All submissions received
identified significant safety risks Policy on Compounding Using Bulk must include the Docket No. FDA–
relating to the use of this bulk drug Drug Substances Under Section 503A of 2015–D–3517 for ‘‘Interim Policy on
substance in compounding. the Federal Food, Drug, and Cosmetic Compounding Using Bulk Drug
• 503B Category 4: The draft interim Act.’’ The guidance describes FDA’s Substances Under Section 503A of the
interim regulatory policy regarding the Federal Food, Drug, and Cosmetic Act.’’
guidance included a fourth category of
use of bulk drug substances by licensed Received comments will be placed in
bulk drug substances that would have
pharmacists in State-licensed the docket and, except for those
identified substances that FDA pharmacies or Federal facilities and by submitted as ‘‘Confidential
evaluated for inclusion on the 503B licensed physicians to compound Submissions,’’ publicly viewable at
bulks list but, after obtaining and human drug products while FDA http://www.regulations.gov or at the
considering public comments, decided develops the list of bulk drug substances Division of Dockets Management
not to place on the 503B bulks list. In that can be used in compounding under between 9 a.m. and 4 p.m., Monday
the final interim guidance, FDA section 503A of the Federal Food, Drug, through Friday.
removed this fourth category because and Cosmetic Act (the FD&C Act). • Confidential Submissions—To
the Agency intends to identify the bulk DATES: Submit electronic or written submit a comment with confidential
drug substances that will not be placed comments on Agency guidances at any information that you do not wish to be
on the 503B bulks list in the Federal time. made publicly available, submit your
Register notice that establishes the 503B ADDRESSES: You may submit comments comments only as a written/paper
bulks list. Therefore, we do not believe as follows: submission. You should submit two
it is necessary to also include them in copies total. One copy will include the
the categories identified in this Electronic Submissions information you claim to be confidential
guidance. Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
II. Electronic Access • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
www.regulations.gov. Follow the Agency will review this copy, including
Persons with access to the Internet the claimed confidential information, in
instructions for submitting comments.
may obtain the document at either its consideration of comments. The
Comments submitted electronically,
http://www.fda.gov/Drugs/Guidance including attachments, to http:// second copy, which will have the
ComplianceRegulatoryInformation/ www.regulations.gov will be posted to claimed confidential information
Guidances/default.htm or http:// the docket unchanged. Because your redacted/blacked out, will be available
www.regulations.gov. comment will be made public, you are for public viewing and posted on http://
Dated: June 7, 2016. solely responsible for ensuring that your www.regulations.gov. Submit both
Leslie Kux, comment does not include any copies to the Division of Dockets
confidential information that you or a Management. If you do not wish your
Associate Commissioner for Policy.
third party may not wish to be posted, name and contact information to be
[FR Doc. 2016–13798 Filed 6–9–16; 8:45 am]
such as medical information, your or made publicly available, you can
BILLING CODE 4164–01–P
anyone else’s Social Security number, or provide this information on the cover
confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
asabaliauskas on DSK3SPTVN1PROD with RULES
that if you include your name, contact information as ‘‘confidential.’’ Any
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
2 In the future, if FDA makes changes to the posted on http://www.regulations.gov. applicable disclosure law. For more
categories of bulk drug substances on its Web site, • If you want to submit a comment information about FDA’s posting of
we intend to follow the procedure identified in the with confidential information that you comments to public dockets, see 80 FR
guidance. do not wish to be made available to the 56469, September 18, 2015, or access
VerDate Sep<11>2014 16:32 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\10JNR1.SGM 10JNR1](https://thefederalregister.org/doc/81_FR_37612/page/3.svg)
Document Created: 2018-02-08 07:36:01
Document Modified: 2018-02-08 07:36:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notice of availability. | |
| Dates | Submit electronic or written comments on Agency guidances at any time. | |
| Contact | Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110. | |
| FR Citation | 81 FR 37500 |
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