81_FR_22684 81 FR 22610 - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

81 FR 22610 - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

Page Range22610-22611
FR Document2016-08879

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.'' This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

Federal Register, Volume 81 Issue 74 (Monday, April 18, 2016) 
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22610-22611]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08879]



[[Page 22610]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0271]


Hospital and Health System Compounding Under 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Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled 
``Hospital and Health System Compounding Under the Federal Food, Drug, 
and Cosmetic Act.'' This guidance describes how FDA intends to apply 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs 
compounded by licensed pharmacists or physicians in State-licensed 
hospital or health system pharmacies.

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draft guidance before it begins work to finalize the guidance, submit 
either electronic or written comments on this draft guidance by July 
18, 2016.

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 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-0271 for ``Hospital and Health System Compounding Under the 
Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; 
Availability''. 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 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 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Hospital and Health System Compounding Under the Federal 
Food, Drug, and Cosmetic Act.'' Pharmacies located within a hospital or 
standalone pharmacies that are part of a health system frequently 
provide compounded drug products for administration within the hospital 
or health system. Some of these compounders have registered with FDA as 
outsourcing facilities under section 503B of the FD&C Act (21 U.S.C. 
353b) and others are State-licensed pharmacies subject to section 503A 
of the FD&C Act (21 U.S.C. 353a).
    Section 503A, added to the FD&C Act by the Food and Drug 
Administration Modernization Act of 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

[[Page 22611]]

new drug applications (NDAs) or abbreviated new drug applications 
(ANDAs)).
    The guidance describes how FDA intends to apply section 503A of the 
FD&C Act to drugs compounded by licensed pharmacists or physicians in 
State-licensed hospital or health system pharmacies.
    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 this topic. 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. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08879 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P

22610 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). default.htm. Docket: For access to the docket to Food and Drug Administration Written/Paper Submissions read background documents or the Submit written/paper submissions as electronic and written/paper comments [Docket No. FDA–2016–D–0271] follows: received, go to http:// Hospital and Health System • Mail/Hand delivery/Courier (for www.regulations.gov and insert the Compounding Under the Federal Food, written/paper submissions): Division of docket number, found in brackets in the Drug, and Cosmetic Act; Draft Dockets Management (HFA–305), Food heading of this document, into the Guidance for Industry; Availability and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets AGENCY: Food and Drug Administration, • For written/paper comments Management, 5630 Fishers Lane, Rm. HHS. submitted to the Division of Dockets 1061, Rockville, MD 20852. ACTION: Notice of availability. Management, FDA will post your Submit written requests for single comment, as well as any attachments, copies of the draft guidance to the SUMMARY: The Food and Drug except for information submitted, Division of Drug Information, Center for Administration (FDA or the Agency) is marked and identified, as confidential, Drug Evaluation and Research, Food announcing the availability of a draft if submitted as detailed in and Drug Administration, 10001 New guidance for industry entitled ‘‘Hospital ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, and Health System Compounding Under 4th Floor, Silver Spring, MD 20993– Instructions: All submissions received the Federal Food, Drug, and Cosmetic 0002. Send one self-addressed adhesive must include the Docket No. FDA– Act.’’ This guidance describes how FDA label to assist that office in processing 2016–D–0271 for ‘‘Hospital and Health intends to apply the Federal Food, Drug, your requests. See the SUPPLEMENTARY System Compounding Under the and Cosmetic Act (the FD&C Act) to INFORMATION section for electronic Federal Food, Drug, and Cosmetic Act; drugs compounded by licensed access to the draft guidance document. Draft Guidance for Industry; pharmacists or physicians in State- Availability’’. Received comments will FOR FURTHER INFORMATION CONTACT: Sara licensed hospital or health system be placed in the docket and, except for Rothman, Center for Drug Evaluation pharmacies. those submitted as ‘‘Confidential and Research, Food and Drug DATES: Although you can comment on Submissions,’’ publicly viewable at Administration, 10903 New Hampshire any guidance at any time (see 21 CFR http://www.regulations.gov or at the Ave., Bldg. 51, Rm. 5197, Silver Spring, 10.115(g)(5)), to ensure that the Agency Division of Dockets Management MD 20993, 301–796–3110. considers your comment on this draft between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: guidance before it begins work to through Friday. I. Background finalize the guidance, submit either • Confidential Submissions—To FDA is announcing the availability of electronic or written comments on this submit a comment with confidential a draft guidance for industry entitled draft guidance by July 18, 2016. information that you do not wish to be ‘‘Hospital and Health System ADDRESSES: You may submit comments made publicly available, submit your Compounding Under the Federal Food, as follows: comments only as a written/paper Drug, and Cosmetic Act.’’ Pharmacies submission. You should submit two located within a hospital or standalone Electronic Submissions copies total. One copy will include the pharmacies that are part of a health Submit electronic comments in the information you claim to be confidential system frequently provide compounded following way: with a heading or cover note that states drug products for administration within • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS the hospital or health system. Some of www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The these compounders have registered with instructions for submitting comments. Agency will review this copy, including FDA as outsourcing facilities under Comments submitted electronically, the claimed confidential information, in section 503B of the FD&C Act (21 U.S.C. including attachments, to http:// its consideration of comments. The 353b) and others are State-licensed www.regulations.gov will be posted to second copy, which will have the pharmacies subject to section 503A of the docket unchanged. Because your claimed confidential information the FD&C Act (21 U.S.C. 353a). comment will be made public, you are redacted/blacked out, will be available Section 503A, added to the FD&C Act solely responsible for ensuring that your for public viewing and posted on http: by the Food and Drug Administration comment does not include any //www.regulations.gov. Submit both Modernization Act of 1997, describes confidential information that you or a copies to the Division of Dockets the conditions that must be satisfied for third party may not wish to be posted, Management. If you do not wish your human drug products compounded by a such as medical information, your or name and contact information to be licensed pharmacist in a State-licensed anyone else’s Social Security number, or made publicly available, you can pharmacy or Federal facility, or by a confidential business information, such provide this information on the cover licensed physician, to be exempt from as a manufacturing process. Please note sheet and not in the body of your the following three sections of the FD&C that if you include your name, contact comments and you must identify this Act: information, or other information that information as ‘‘confidential.’’ Any • Section 501(a)(2)(B) (21 U.S.C. mstockstill on DSK4VPTVN1PROD with NOTICES identifies you in the body of your information marked as ‘‘confidential’’ 351(a)(2)(B)) (concerning current good comments, that information will be will not be disclosed except in manufacturing practice requirements); posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other • section 502(f)(1) (21 U.S.C. • If you want to submit a comment applicable disclosure law. For more 352(f)(1)) (concerning the labeling of with confidential information that you information about FDA’s posting of drugs with adequate directions for use); do not wish to be made available to the comments to public dockets, see 80 FR and public, submit the comment as a 56469, September 18, 2015, or access • section 505 (21 U.S.C. 355) written/paper submission and in the the information at: http://www.fda.gov/ (concerning the approval of drugs under VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1

Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices 22611 new drug applications (NDAs) or draft guidance to answer these those submitted as ‘‘Confidential abbreviated new drug applications questions. Submissions,’’ publicly viewable at (ANDAs)). DATES: Although you can comment on http://www.regulations.gov or at the The guidance describes how FDA Division of Dockets Management any guidance at any time (see 21 CFR intends to apply section 503A of the between 9 a.m. and 4 p.m., Monday 10.115(g)(5)), to ensure that the Agency FD&C Act to drugs compounded by through Friday. considers your comment on this draft licensed pharmacists or physicians in guidance before it begins work on the • Confidential Submissions—To State-licensed hospital or health system submit a comment with confidential final version of the guidance, submit pharmacies. information that you do not wish to be This draft guidance is being issued either electronic or written comments on the draft guidance by July 18, 2016. made publicly available, submit your consistent with FDA’s good guidance comments only as a written/paper practices regulation (21 CFR 10.115). ADDRESSES: You may submit comments submission. You should submit two The draft guidance, when finalized, will as follows: copies total. One copy will include the represent the current thinking of FDA Electronic Submissions information you claim to be confidential on this topic. It does not establish any with a heading or cover note that states rights for any person and is not binding Submit electronic comments in the following way: ‘‘THIS DOCUMENT CONTAINS on FDA or the public. You can use an CONFIDENTIAL INFORMATION’’. The alternative approach if it satisfies the • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the Agency will review this copy, including requirements of the applicable statutes the claimed confidential information, in and regulations. instructions for submitting comments. Comments submitted electronically, its consideration of comments. The II. Electronic Access including attachments, to http:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information Persons with access to the Internet the docket unchanged. Because your redacted/blacked out, will be available may obtain the draft guidance at either comment will be made public, you are for public viewing and posted on http:// http://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your www.regulations.gov. Submit both ComplianceRegulatoryInformation/ comment does not include any copies to the Division of Dockets Guidances/default.htm or http:// confidential information that you or a Management. If you do not wish your www.regulations.gov. third party may not wish to be posted, name and contact information to be Dated: April 12, 2016. made publicly available, you can such as medical information, your or Leslie Kux, provide this information on the cover anyone else’s Social Security number, or Associate Commissioner for Policy. confidential business information, such sheet and not in the body of your [FR Doc. 2016–08879 Filed 4–15–16; 8:45 am] as a manufacturing process. Please note comments and you must identify this BILLING CODE 4164–01–P 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 DEPARTMENT OF HEALTH AND accordance with 21 CFR 10.20 and other comments, that information will be HUMAN SERVICES applicable disclosure law. For more posted on http://www.regulations.gov. • If you want to submit a comment information about FDA’s posting of Food and Drug Administration comments to public dockets, see 80 FR with confidential information that you [Docket No. FDA–2016–D–0238] do not wish to be made available to the 56469, September 18, 2015, or access public, submit the comment as a the information at: http://www.fda.gov/ Facility Definition Under Section 503B written/paper submission and in the regulatoryinformation/dockets/ of the Federal Food, Drug, and manner detailed (see ‘‘Written/Paper default.htm. Cosmetic Act; Availability Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to read background documents or the AGENCY: Food and Drug Administration, Written/Paper Submissions electronic and written/paper comments HHS. Submit written/paper submissions as received, go to http:// ACTION: Notice. www.regulations.gov and insert the follows: SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for docket number, found in brackets in the Administration (FDA or Agency) is written/paper submissions): Division of heading of this document, into the announcing the availability of a draft Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts guidance for industry entitled ‘‘Facility and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Definition Under Section 503B of the Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Federal Food, Drug, and Cosmetic Act.’’ • For written/paper comments 1061, Rockville, MD 20852. Section 503B defines an outsourcing submitted to the Division of Dockets Submit written requests for single facility, in part, as ‘‘a facility at one Management, FDA will post your copies of the draft guidance to the geographic location or address.’’ FDA comment, as well as any attachments, Division of Drug Information, Center for has received questions from outsourcing except for information submitted, Drug Evaluation and Research, Food facilities and other stakeholders about marked and identified, as confidential, and Drug Administration, 10001 New the meaning of this term, such as if submitted as detailed in Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– mstockstill on DSK4VPTVN1PROD with NOTICES whether multiple suites used for ‘‘Instructions.’’ compounding human drugs at a single Instructions: All submissions received 0002. Send one self-addressed adhesive street address constitute one or multiple must include the Docket No. FDA– label to assist that office in processing facilities, or whether a single location 2016–D–0238 for ‘‘Facility Definition your requests. See the SUPPLEMENTARY where human drugs are compounded Under Section 503B of the Federal INFORMATION section for electronic can be subdivided into separate Food, Drug, and Cosmetic Act; access to the draft guidance document. operations compounding under Availability.’’ Received comments will FOR FURTHER INFORMATION CONTACT: Sara different standards. FDA is issuing this be placed in the docket and, except for Rothman, Center for Drug Evaluation VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1


Document Created: 2016-04-16 01:45:57
Document Modified: 2016-04-16 01:45:57
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 of availability.
DatesAlthough 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 July 18, 2016.
ContactSara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796- 3110.
FR Citation81 FR 22610 
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