80_FR_12549 80 FR 12504 - Compounding of Human Drug Products Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

80 FR 12504 - Compounding of Human Drug Products Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 45 (March 9, 2015)

Page Range12504-12505
FR Document2015-05376

The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets.

Federal Register, Volume 80 Issue 45 (Monday, March 9, 2015) 
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12504-12505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0030]


Compounding of Human Drug Products Under the Federal Food, Drug, 
and Cosmetic Act; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to receive information, recommendations, 
and comments on matters related to the Agency's regulation of 
compounding of human drug products under sections 503A and 503B of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is 
intended for general comments related to human drug compounding that 
are not specific to documents or issues that are the subject of other 
dockets.

DATES: Comments may be submitted to this docket at any time.

ADDRESSES: You may submit comments, identified by Docket No. [FDA-2015-
N-0030], by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. [FDA-2015-N-0030]. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
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 (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philantha Bowen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg.51, Rm. 5175, Silver Spring, MD 20993-0002, 301-
796-2466.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the 
conditions that must be satisfied for human drug products compounded by 
a licensed pharmacist or licensed physician to be exempt from the 
following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); 
(2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of 
drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 
355) (concerning the approval of drugs under new drug applications or 
abbreviated new drug applications). Previously, the conditions of 
section 503A of the FD&C Act also included restrictions on the 
advertising or promotion of the compounding of any particular drug, 
class of drug, or type of drug and the solicitation of prescriptions 
for compounded drugs. These provisions were challenged in court and 
held unconstitutional by the U.S. Supreme Court in 2002.\1\
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    \1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357 
(2002).
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    On November 27, 2013, President Obama signed the Drug Quality and 
Security Act (DQSA) (Pub. L. 113-54), which contains important 
provisions relating to the oversight of human drug compounding. This 
new law removes from section 503A of the FD&C Act the provisions that 
had been held unconstitutional by the U.S. Supreme Court in 2002. By 
removing these provisions, the new law clarifies that section 503A of 
the FD&C Act applies nationwide. In addition, the DQSA adds a new 
section, 503B, to the FD&C Act (21 U.S.C. 353b) that creates a new 
category of ``outsourcing facilities''. Outsourcing facilities, as 
defined in section 503B of the FD&C Act, are facilities that meet 
certain conditions described in section 503B, including registration 
with FDA as an outsourcing facility. If these conditions are satisfied, 
a drug compounded for human use by or under the direct supervision of a 
licensed pharmacist in an outsourcing facility is exempt from three 
sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and 
(3) section 582 (21 U.S.C. 360eee), but not section 501(a)(2)(B).
    Since enactment of the DQSA, FDA has sought public comment on a 
number of specific human drug compounding issues and has published 
several Federal Register notices seeking public input. These have 
included notices inviting comment on the registration process and 
product reporting requirements for human drug compounding outsourcing 
facilities (78 FR 72899 and 78 FR 72897), requesting nominations for 
the list of drugs that present demonstrable difficulties for 
compounding (78 FR 72840), and seeking input on other specific matters. 
A complete list of the human drug compounding policy documents issued 
by the Agency for public comment can be found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm. The Agency will continue to seek public comment on 
specific documents and issues through future Federal Register notices. 
The Agency recognizes, however, that it would be useful to have a 
docket available for submissions of any information related to human 
drug compounding that may be unrelated to the specific issues and 
documents published for public comment.

II. Establishment of a Docket

    FDA is establishing a public docket so that anyone can share 
information, research, and ideas on any matters related to human drug 
compounding that are not specific to the documents or issues addressed 
in other dockets. This information will give the Agency insight into 
stakeholders' experiences and views regarding human drug compounding as 
the Agency works to implement sections 503A and 503B of the FD&C Act.
    This docket will be open for comment simultaneously with a number 
of other dockets that are specific to particular human drug compounding 
documents or issues (see http://www.fda.gov/drugs/

[[Page 12505]]

guidancecomplianceregulatoryinformation/pharmacycompounding/default.htm 
for a list of specific human drug compounding policy documents open for 
public comment). Please do not submit comments to this general docket 
that have already been submitted to specific dockets. Such submissions 
are duplicative and not helpful to the Agency. If comments on 
particular documents or issues are submitted to this docket rather than 
the docket specifically opened for the particular document or issue, 
the comment might not be considered as the specific documents are being 
finalized and issues considered. FDA will not respond to questions or 
requests submitted to this docket but will consider any information 
submitted in its work to implement the law.
    Information in the docket will be publicly available. Therefore, we 
remind commenters not to submit personal or confidential information.
    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in the 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05376 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P

12504 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices will be posted to the docket at http:// Instructions: All submissions received nationwide. In addition, the DQSA adds www.regulations.gov. must include the Agency name and a new section, 503B, to the FD&C Act Docket No. [FDA–2015–N–0030]. All (21 U.S.C. 353b) that creates a new V. Electronic Access comments received may be posted category of ‘‘outsourcing facilities’’. Persons with access to the Internet without change to http:// Outsourcing facilities, as defined in may obtain the document at either www.regulations.gov, including any section 503B of the FD&C Act, are http://www.fda.gov/Drugs/Guidance personal information provided. facilities that meet certain conditions ComplianceRegulatoryInformation/ Docket: For access to the docket to described in section 503B, including Guidances/default.htm or http:// read background documents or registration with FDA as an outsourcing www.regulations.gov. comments received, go to http:// facility. If these conditions are satisfied, Dated: March 3, 2015. www.regulations.gov and insert the a drug compounded for human use by docket number found in brackets in the or under the direct supervision of a Leslie Kux, heading of this document, into the licensed pharmacist in an outsourcing Associate Commissioner for Policy. ‘‘Search’’ box and follow the prompts facility is exempt from three sections of [FR Doc. 2015–05347 Filed 3–6–15; 8:45 am] and/or go to the Division of Dockets the FD&C Act: (1) Section 502(f)(1), (2) BILLING CODE 4164–01–P Management (HFA–305), Food and Drug section 505, and (3) section 582 (21 Administration, 5630 Fishers Lane, Rm. U.S.C. 360eee), but not section 1061, Rockville, MD 20852. 501(a)(2)(B). DEPARTMENT OF HEALTH AND Since enactment of the DQSA, FDA FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES Philantha Bowen, Center for Drug has sought public comment on a Evaluation and Research, Food and number of specific human drug Food and Drug Administration Drug Administration, 10903 New compounding issues and has published [Docket No. FDA–2015–N–0030] Hampshire Ave., Bldg.51, Rm. 5175, several Federal Register notices seeking Silver Spring, MD 20993–0002, 301– public input. These have included Compounding of Human Drug 796–2466. notices inviting comment on the Products Under the Federal Food, registration process and product SUPPLEMENTARY INFORMATION: Drug, and Cosmetic Act; reporting requirements for human drug Establishment of a Public Docket I. Background compounding outsourcing facilities (78 AGENCY: Food and Drug Administration, Section 503A of the FD&C Act (21 FR 72899 and 78 FR 72897), requesting HHS. U.S.C. 353a) describes the conditions nominations for the list of drugs that that must be satisfied for human drug present demonstrable difficulties for ACTION: Notice; establishment of public products compounded by a licensed compounding (78 FR 72840), and docket. pharmacist or licensed physician to be seeking input on other specific matters. SUMMARY: The Food and Drug exempt from the following three A complete list of the human drug Administration (FDA or Agency) is sections of the FD&C Act: (1) Section compounding policy documents issued establishing a public docket to receive 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) by the Agency for public comment can information, recommendations, and (concerning current good manufacturing be found at http://www.fda.gov/Drugs/ comments on matters related to the practice); (2) section 502(f)(1) (21 U.S.C. GuidanceCompliance 352(f)(1)) (concerning the labeling of RegulatoryInformation/Pharmacy Agency’s regulation of compounding of drugs with adequate directions for use); Compounding/ucm166743.htm. The human drug products under sections and (3) section 505 (21 U.S.C. 355) Agency will continue to seek public 503A and 503B of the Federal Food, (concerning the approval of drugs under comment on specific documents and Drug, and Cosmetic Act (FD&C Act). new drug applications or abbreviated issues through future Federal Register This docket is intended for general new drug applications). Previously, the notices. The Agency recognizes, comments related to human drug conditions of section 503A of the FD&C however, that it would be useful to have compounding that are not specific to Act also included restrictions on the a docket available for submissions of documents or issues that are the subject advertising or promotion of the any information related to human drug of other dockets. compounding of any particular drug, compounding that may be unrelated to DATES: Comments may be submitted to class of drug, or type of drug and the the specific issues and documents this docket at any time. solicitation of prescriptions for published for public comment. ADDRESSES: You may submit comments, compounded drugs. These provisions identified by Docket No. [FDA–2015–N– II. Establishment of a Docket were challenged in court and held 0030], by any of the following methods. unconstitutional by the U.S. Supreme FDA is establishing a public docket so Court in 2002.1 that anyone can share information, Electronic Submissions research, and ideas on any matters On November 27, 2013, President Submit electronic comments in the Obama signed the Drug Quality and related to human drug compounding following way: Security Act (DQSA) (Pub. L. 113–54), that are not specific to the documents or • Federal eRulemaking Portal: http:// which contains important provisions issues addressed in other dockets. This www.regulations.gov. Follow the relating to the oversight of human drug information will give the Agency insight instructions for submitting comments. compounding. This new law removes into stakeholders’ experiences and from section 503A of the FD&C Act the views regarding human drug Written Submissions mstockstill on DSK4VPTVN1PROD with NOTICES provisions that had been held compounding as the Agency works to Submit written comments in the unconstitutional by the U.S. Supreme implement sections 503A and 503B of following ways: Court in 2002. By removing these the FD&C Act. • Mail/Hand delivery/Courier (for provisions, the new law clarifies that This docket will be open for comment paper submissions): Division of Dockets section 503A of the FD&C Act applies simultaneously with a number of other Management (HFA–305), Food and Drug dockets that are specific to particular Administration, 5630 Fishers Lane, Rm. 1 See Thompson v. Western States Med. Ctr., 535 human drug compounding documents 1061, Rockville, MD 20852. U.S. 357 (2002). or issues (see http://www.fda.gov/drugs/ VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12505 guidancecompliance and recreational navigation with a focus searchable online (see the Federal regulatoryinformation/pharmacy on the existing aids to navigation in Register Privacy Act notice regarding compounding/default.htm for a list of Missouri River system from Sioux City, our public dockets, 73 FR 3316, Jan. 17, specific human drug compounding IA to St. Louis, MO. This listening 2008). policy documents open for public session will be open to the public. Mailed or hand-delivered comments comment). Please do not submit DATES: This listening session will be should be in an unbound 81⁄2 x 11 inch comments to this general docket that held in Smithville, MO on February 25, format suitable for reproduction. The have already been submitted to specific 2015, from 10:00 a.m. to 12:00 p.m. If Docket Management Facility will dockets. Such submissions are all interested participants have had an acknowledge receipt of mailed duplicative and not helpful to the opportunity to comment, the session comments if you enclose a stamped, Agency. If comments on particular may conclude early. Written comments self-addressed postcard or envelope documents or issues are submitted to and related material may also be with your submission. this docket rather than the docket presented to Coast Guard personnel Documents mentioned in this notice, specifically opened for the particular specified at that meeting. Comments and all public comments, may be found document or issue, the comment might and related materials submitted after the in our online docket at http:// not be considered as the specific meeting must be received by the Coast www.regulations.gov and can be viewed documents are being finalized and Guard on or before April 10, 2015. by following the Web site’s instructions. issues considered. FDA will not respond ADDRESSES: The listening session will You can also view the docket at the to questions or requests submitted to be held at the Jerry Litton Visitors Docket Management Facility (see the this docket but will consider any Center, (Smithville Lake) 16311 DD mailing address under ADDRESSES) information submitted in its work to Hwy., Smithville, MO 64089. between 9 a.m. and 5 p.m., Monday implement the law. Submit written comments identified through Friday, except Federal holidays. Information in the docket will be For information on facilities or by docket number USCG–2015–0031 publicly available. Therefore, we services for individuals with disabilities using one of the listed methods, and see remind commenters not to submit or to request special assistance at the SUPPLEMENTARY INFORMATION for more personal or confidential information. listening session, contact Kevin information on public comments. To Interested persons may submit either Brensinger at the telephone number or avoid duplication, please use only one electronic comments to http:// email address indicated under the FOR of these methods. www.regulations.gov or written FURTHER INFORMATION CONTACT section of • Online—http://www.regulations.gov comments to the Division of Dockets following Web site instructions. this notice. Management (see ADDRESSES). It is only • Fax—202–493–2251. Basis and Purpose necessary to send one set of comments. • Mail or hand deliver—Docket Identify comments with the docket The Waterways Analysis and Management Facility (M–30), U.S. number found in the brackets in the Management System was implemented Department of Transportation, West heading of this document. Received to ensure a complete and organized Building Ground Floor, Room W12–140, comments may be seen in the Division process for matching waterway 1200 New Jersey Avenue SE., of Dockets Management between 9 a.m. attributes and services, most Washington, DC 20590–0001. Hours for and 4 p.m., Monday through Friday, and significantly the aids to navigation hand delivery are 9 a.m. to 5 p.m., will be posted to the docket at http:// system, with user needs. The Missouri Monday through Friday, except Federal www.regulations.gov. River study includes navigable waters holidays (telephone 202–366–9329). from Sioux City, IA to St. Louis, MO Dated: March 3, 2015. FOR FURTHER INFORMATION CONTACT: For and specifically targets the navigation Leslie Kux, information about this document call or channel, marking of the navigation Associate Commissioner for Policy. email Kevin Brensinger, Coast Guard; channel, movement of commerce and [FR Doc. 2015–05376 Filed 3–6–15; 8:45 am] telephone 314–269–2548, email navigation support for the diverse uses BILLING CODE 4164–01–P SUMRWaterways@uscg.mil. For of the river. WAMS studies are information about viewing or submitting conducted periodically to better material to the docket, call Cheryl understand users’ needs and facilitate Collins, Program Manager, Docket safe and effective waterways. Some of DEPARTMENT OF HOMELAND Operations, telephone 202–366–9826, the aspects addressed by WAMS are: SECURITY toll free 1–800–647–5527. • Are all the aids necessary? Coast Guard SUPPLEMENTARY INFORMATION: • Should aids be added, changed or Public Participation and Comments removed? [Docket No. USCG–2015–0031] • Is the right aid being used for the We encourage you to participate in job? Missouri River Waterways Analysis and Management System this listening session by submitting • Are the aids marked in a correct comments (or related material) on and visible manner? AGENCY: Coast Guard, DHS. Missouri River Waterways Analysis and • Are these aids being used properly ACTION:Notice of meeting and request Management System study. by both the Coast Guard and the for comments. We recommend using the user survey waterway users? document under docket number USCG– It is the intent of Coast Guard Sector mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: Coast Guard Sector Upper 2015–0031 to provide comments. You Upper Mississippi River to collect Mississippi River will hold a public should provide personal contact comments and materials from this listening session to present, and receive information so that we can contact you listening session, along with navigation feedback on, the Missouri River if we have questions regarding your surveys and other information, to Waterways Analysis and Management comments; but please note that all establish and preserve the reasonable System (WAMS) study. The WAMS comments will be posted to the online needs of navigation on this river. study will review and assess waterborne docket without change and that any This notice is issued under authority commerce as well as safe commercial personal information you include can be of 5 U.S.C. 552(a). VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1


Document Created: 2015-12-18 12:06:02
Document Modified: 2015-12-18 12:06:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of public docket.
DatesComments may be submitted to this docket at any time.
ContactPhilantha Bowen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.51, Rm. 5175, Silver Spring, MD 20993-0002, 301- 796-2466.
FR Citation80 FR 12504 
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