80_FR_49405 80 FR 49247 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period

80 FR 49247 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range49247-49248
FR Document2015-20174

The Food and Drug Administration (FDA) is extending the comment period for the document that appeared in the Federal Register of May 19, 2015. In the document, FDA requested comments on draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015) 
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49247-49248]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1176]


Compounding Animal Drugs From Bulk Drug Substances; Draft 
Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the document that appeared in the Federal Register 
of May 19, 2015. In the document, FDA requested comments on draft 
guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs 
from Bulk Drug Substances.'' FDA is taking this action in response to a 
request for an extension to allow interested persons additional time to 
submit comments.

DATES: FDA is extending the comment period on the document published 
May 19, 2015 (80 FR 28624). Submit either electronic or written 
comments on the draft guidance by November 16, 2015.

ADDRESSES: You may submit comments 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 Docket No. 
FDA-2015-D-1176. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    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, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Division of Compliance, Center for 
Veterinary Medicine, Food and Drug Administration (HFV-230), 7519 
Standish Pl., Rockville, MD 20855, 240-402-7001, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 2015, FDA published a document 
with a 90-day comment period for draft GFI #230 entitled ``Compounding 
Animal Drugs from Bulk Drug Substances.'' The draft guidance describes 
FDA's policies with regard to compounding animal drugs from bulk drug 
substances. When final, the guidance will reflect FDA's current 
thinking on the issues addressed by the guidance.
    FDA has received a request for a 90-day extension of the comment 
period. The request conveyed concern that the current 90-day comment 
period does not allow sufficient time to respond. FDA has considered 
the request and is extending the comment period for 90 days, until 
November 16, 2015. FDA believes that a 90-day extension allows adequate 
time for interested persons to submit comments without significantly 
delaying further FDA action on this guidance document.

II. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are 
specifically requesting comments on the following issues:
     Should the final guidance address the issue of FDA-
approved animal and human drugs that are in shortage or are otherwise 
unavailable (e.g., disruptions in the manufacture or supply chain; 
business decisions to stop marketing the drug; drug is subject to 
Agency action based on safety, effectiveness, or manufacturing 
concerns)? If so:
    [cir] How should these situations be addressed in the final 
guidance?
    [cir] How should the final guidance define the terms ``shortage'' 
and ``unavailable''?
    [cir] What criteria should FDA use to determine if an approved 
animal or human drug is in shortage or otherwise unavailable?
     Do United States Pharmacopeia and National Formulary (USP-
NF) \1\ chapters 795 and 797 provide suitable standards for animal 
drugs compounded by veterinarians, and if not, what standards of 
safety, purity, and quality should apply to animal drugs compounded by 
veterinarians?
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    \1\ Chapters <795> ``Pharmaceutical Compounding--Nonsterile 
Preparations'' and <797> ``Pharmaceutical Compounding--Sterile 
Preparations'' can be found in both the USP Compounding Compendium 
and the combined United States Pharmacopeia and National Formulary 
(USP-NF). These compendia are available at http://www.usp.org/.
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     Should licensed veterinarians be able to sell or transfer 
an animal drug compounded from bulk drug substances by a State-licensed 
pharmacy or an outsourcing facility to owners or caretakers of animals 
under the veterinarian's care?
     Should the final guidance include a condition on the 
amount or percentage of compounded animal drugs that a pharmacy or 
outsourcing facility can ship in interstate commerce? If so, what would 
a reasonable amount be?
     Is additional guidance needed to address the repackaging 
of drugs for animal use?
    [cir] How widespread is the practice of repackaging drugs for 
animal use?
    [cir] What types of drugs are repackaged for animal use, and why 
are they repackaged?
    [cir] Have problems been identified with repackaged drugs for 
animal use?
     Is additional guidance needed to address the compounding 
of animal drugs from approved animal or human drugs under section 
512(a)(4) or (a)(5) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360b(a)(4) and (a)(5)) and 21 CFR part 530?
     Is additional guidance needed to address the compounding 
of animal drugs from bulk drug substances for food-producing animals?

[[Page 49248]]

     As one condition under which FDA does not generally intend 
to take action for certain violations of the FD&C Act if this and the 
other conditions are followed, FDA is proposing that State-licensed 
pharmacies and veterinarians report any product defect or serious 
adverse event associated with animal drugs they compound from bulk drug 
substances to FDA within 15 days of becoming aware of the product 
defect or serious adverse event. Outsourcing facilities are required to 
report adverse events associated with the drugs they compound. FDA 
believes it is important to receive this information from State-
licensed pharmacies and veterinarians because there are no other State 
Departments of Health or Federal Agencies (e.g., the Centers for 
Disease Control and Prevention) charged with identifying and tracing 
animal injuries or disease associated with an animal drug compounded by 
these entities. FDA has the following specific questions with respect 
to this proposed condition:
    [cir] How many State-licensed pharmacies and veterinarians compound 
animal drugs from bulk drug substances and would potentially be 
reporting product defects and serious adverse events to FDA?
    [cir] Are State-licensed pharmacies and veterinarians reporting the 
same or similar information to any State regulatory agency (e.g., State 
boards of pharmacy, State boards of veterinary medicine)? If so, how 
many reports on average does each State-licensed pharmacy and 
veterinarian submit to these State agencies each year?
    [cir] For purposes of the guidance, how should FDA define the terms 
``product defect'' and ``serious adverse event?''
    [cir] Can FDA achieve the same objective of identifying and tracing 
the source of injuries or disease associated with an animal drug 
compounded from a bulk drug substance through means other than product 
defect and serious adverse event reporting, and if so, what other 
means? For example, would reports of product defects alone achieve the 
same objective?

III. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document 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 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or 
http://www.regulations.gov.

    Dated: August 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20174 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices 49247 docket number found in brackets in the Written Submissions requesting comments on the following heading of this document. Received issues: Submit written comments in the comments may be seen in the Division • Should the final guidance address following ways: the issue of FDA-approved animal and of Dockets Management between 9 a.m. • Mail/Hand delivery/Courier (for human drugs that are in shortage or are and 4 p.m., Monday through Friday, and paper submissions): Division of Dockets otherwise unavailable (e.g., disruptions will be posted to the docket at http:// Management (HFA–305), Food and Drug in the manufacture or supply chain; www.regulations.gov. Administration, 5630 Fishers Lane, Rm. business decisions to stop marketing the IV. Electronic Access 1061, Rockville, MD 20852. drug; drug is subject to Agency action Persons with access to the Internet Instructions: All submissions received based on safety, effectiveness, or may obtain the document at http:// must include the Docket No. FDA– manufacturing concerns)? If so: www.fda.gov/Drugs/ 2015–D–1176. All comments received Æ How should these situations be GuidanceCompliance may be posted without change to addressed in the final guidance? RegulatoryInformation/Guidances/ http://www.regulations.gov, including Æ How should the final guidance default.htm, http://www.fda.gov/ any personal information provided. For define the terms ‘‘shortage’’ and BiologicsBloodVaccines/ additional information on submitting ‘‘unavailable’’? GuidanceCompliance comments, see the ‘‘Request for Æ What criteria should FDA use to RegulatoryInformation/default.htm, or Comments’’ heading of the determine if an approved animal or http://www.regulations.gov. SUPPLEMENTARY INFORMATION section of human drug is in shortage or otherwise this document. unavailable? Dated: August 12, 2015. Docket: For access to the docket to • Do United States Pharmacopeia and Leslie Kux, read background documents or National Formulary (USP–NF) 1 Associate Commissioner for Policy. comments received, go to http:// chapters 795 and 797 provide suitable [FR Doc. 2015–20235 Filed 8–14–15; 8:45 am] www.regulations.gov and insert the standards for animal drugs compounded BILLING CODE 4164–01–P docket number, found in brackets in the by veterinarians, and if not, what heading of this document, into the standards of safety, purity, and quality ‘‘Search’’ box and follow the prompts should apply to animal drugs DEPARTMENT OF HEALTH AND and/or go to the Division of Dockets compounded by veterinarians? HUMAN SERVICES Management, 5630 Fishers Lane, Rm. • Should licensed veterinarians be 1061, Rockville, MD 20852. able to sell or transfer an animal drug Food and Drug Administration compounded from bulk drug substances FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2015–D–1176] by a State-licensed pharmacy or an Division of Compliance, Center for outsourcing facility to owners or Veterinary Medicine, Food and Drug caretakers of animals under the Compounding Animal Drugs From Administration (HFV–230), 7519 Bulk Drug Substances; Draft Guidance veterinarian’s care? Standish Pl., Rockville, MD 20855, 240– • Should the final guidance include a for Industry; Extension of Comment 402–7001, CVMCompliance@ Period condition on the amount or percentage fda.hhs.gov. of compounded animal drugs that a AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: pharmacy or outsourcing facility can HHS. ship in interstate commerce? If so, what ACTION: Notice; extension of comment I. Background would a reasonable amount be? period. In the Federal Register of May 19, • Is additional guidance needed to 2015, FDA published a document with address the repackaging of drugs for SUMMARY: The Food and Drug a 90-day comment period for draft GFI animal use? Administration (FDA) is extending the #230 entitled ‘‘Compounding Animal Æ How widespread is the practice of comment period for the document that Drugs from Bulk Drug Substances.’’ The repackaging drugs for animal use? appeared in the Federal Register of May draft guidance describes FDA’s policies Æ What types of drugs are repackaged 19, 2015. In the document, FDA with regard to compounding animal for animal use, and why are they requested comments on draft guidance drugs from bulk drug substances. When repackaged? for industry (GFI) #230 entitled final, the guidance will reflect FDA’s Æ Have problems been identified with ‘‘Compounding Animal Drugs from Bulk current thinking on the issues addressed repackaged drugs for animal use? Drug Substances.’’ FDA is taking this • Is additional guidance needed to by the guidance. action in response to a request for an address the compounding of animal FDA has received a request for a 90- extension to allow interested persons drugs from approved animal or human day extension of the comment period. additional time to submit comments. drugs under section 512(a)(4) or (a)(5) of The request conveyed concern that the DATES: FDA is extending the comment the Federal Food, Drug, and Cosmetic current 90-day comment period does period on the document published May Act (the FD&C Act) (21 U.S.C. 360b(a)(4) not allow sufficient time to respond. 19, 2015 (80 FR 28624). Submit either and (a)(5)) and 21 CFR part 530? FDA has considered the request and is • Is additional guidance needed to electronic or written comments on the extending the comment period for 90 address the compounding of animal draft guidance by November 16, 2015. days, until November 16, 2015. FDA drugs from bulk drug substances for ADDRESSES: You may submit comments believes that a 90-day extension allows food-producing animals? mstockstill on DSK4VPTVN1PROD with NOTICES by any of the following methods. adequate time for interested persons to submit comments without significantly 1 Chapters <795> ‘‘Pharmaceutical Electronic Submissions delaying further FDA action on this Compounding—Nonsterile Preparations’’ and Submit electronic comments in the guidance document. <797> ‘‘Pharmaceutical Compounding—Sterile following way: Preparations’’ can be found in both the USP • Federal eRulemaking Portal: http:// II. Specific Topics for Comment Compounding Compendium and the combined United States Pharmacopeia and National www.regulations.gov. Follow the In addition to comments on the draft Formulary (USP–NF). These compendia are instructions for submitting comments. guidance as written, we are specifically available at http://www.usp.org/. VerDate Sep<11>2014 16:57 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1

49248 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices • As one condition under which FDA will be posted to the docket at http:// Health, Food and Drug Administration, does not generally intend to take action www.regulations.gov. 10903 New Hampshire Ave., Bldg. 66, for certain violations of the FD&C Act if Rm. 2534, Silver Spring, MD 20993, IV. Electronic Access this and the other conditions are 301–796–6445, email: followed, FDA is proposing that State- Persons with access to the Internet Bahram.Parvinian@fda.hhs.gov; and licensed pharmacies and veterinarians may obtain the draft guidance at either Allison Kumar, Center for Devices and report any product defect or serious http://www.fda.gov/AnimalVeterinary/ Radiological Health, Food and Drug adverse event associated with animal GuidanceComplianceEnforcement/ Administration, 10903 New Hampshire drugs they compound from bulk drug GuidanceforIndustry/ucm042450.htm or Ave., Bldg. 66, Rm. 5402, Silver Spring, substances to FDA within 15 days of http://www.regulations.gov. MD 20993, 301–796–6369, email: becoming aware of the product defect or Dated: August 11, 2015. Allison.Kumar@fda.hhs.gov. serious adverse event. Outsourcing Leslie Kux, Registration: Registration is free and facilities are required to report adverse Associate Commissioner for Policy. available on a first-come, first-served events associated with the drugs they basis. Persons interested in attending [FR Doc. 2015–20174 Filed 8–14–15; 8:45 am] compound. FDA believes it is important this public workshop must register BILLING CODE 4164–01–P to receive this information from State- online by 4 p.m., October 1, 2015. Early licensed pharmacies and veterinarians registration is recommended because because there are no other State facilities are limited and, therefore, FDA DEPARTMENT OF HEALTH AND Departments of Health or Federal may limit the number of participants HUMAN SERVICES Agencies (e.g., the Centers for Disease from each organization. If time and Control and Prevention) charged with Food and Drug Administration space permits, onsite registration on the identifying and tracing animal injuries day of the public workshop will be or disease associated with an animal [Docket No. FDA–2015–N–2734] provided beginning at 7 a.m. drug compounded by these entities. If you need special accommodations Physiological Closed-Loop Controlled due to a disability, please contact Susan FDA has the following specific Devices; Public Workshop; Request Monahan, Office of Communication and questions with respect to this proposed for Comments Education (OCE), Center for Devices and condition: Æ How many State-licensed AGENCY: Food and Drug Administration, Radiological Health, Food and Drug pharmacies and veterinarians HHS. Administration, 301–796–5661, email: compound animal drugs from bulk drug ACTION: Notice of public workshop; susan.monahan@fda.hhs.gov no later substances and would potentially be request for comments. than September 29, 2015. reporting product defects and serious To register for the public workshop, adverse events to FDA? SUMMARY: The Food and Drug please visit FDA’s Medical Devices Æ Are State-licensed pharmacies and Administration (FDA) is announcing the News & Events—Workshops & veterinarians reporting the same or following public workshop entitled Conferences calendar at http:// similar information to any State ‘‘Physiological Closed-Loop Controlled www.fda.gov/MedicalDevices/ regulatory agency (e.g., State boards of (PCLC) Devices.’’ The topic to be NewsEvents/WorkshopsConferences/ pharmacy, State boards of veterinary discussed is challenges related to the default.htm. (Select this meeting/public medicine)? If so, how many reports on design, development, and evaluation of workshop from the posted events list.) average does each State-licensed critical care PCLC devices. FDA Please provide complete contact pharmacy and veterinarian submit to considers PCLC devices an emerging information for each attendee, including these State agencies each year? technology and aims to hold a workshop name, title, affiliation, address, email, Æ For purposes of the guidance, how focusing on design, development and and telephone number. Those without should FDA define the terms ‘‘product performance evaluation of PCLC Internet access should contact Susan defect’’ and ‘‘serious adverse event?’’ systems intended for use in critical care Monahan to register. Registrants will Æ Can FDA achieve the same environments. Such devices include receive confirmation after they have objective of identifying and tracing the closed-loop anesthetic delivery, closed- been accepted. You will be notified if source of injuries or disease associated loop vasoactive drug and fluid delivery, you are on a waiting list. with an animal drug compounded from and closed-loop mechanical ventilation. Streaming Webcast of the Public a bulk drug substance through means Dates and Times: The public Workshop: This public workshop will other than product defect and serious workshop will be held on October 13 also be Webcast. Persons interested in adverse event reporting, and if so, what and 14, 2015, from 8 a.m. to 5 p.m. viewing the Webcast must register other means? For example, would Location: The public workshop will online by 4 p.m., October 1, 2015. Early reports of product defects alone achieve be held at FDA’s White Oak Campus, registration is recommended because the same objective? 10903 New Hampshire Ave., Building Webcast connections are limited. 31 Conference Center, Rm. 1503 (The Organizations are requested to register III. Request for Comments all participants, but to view using one Great Room), Silver Spring, MD 20993. Interested persons may submit either Entrance for the public meeting connection per location. Webcast electronic comments regarding this participants (non-FDA employees) is participants will be sent technical document to http://www.regulations.gov through Building 1 where routine system requirements after registration or written comments to the Division of security check procedures will be and will be sent connection access mstockstill on DSK4VPTVN1PROD with NOTICES Dockets Management (see ADDRESSES). It performed. For parking and security information after October 7, 2015. If you is only necessary to send one set of information, please refer to http:// have never attended a Connect Pro comments. Identify comments with the www.fda.gov/AboutFDA/ event before, test your connection at docket number found in brackets in the WorkingatFDA/BuildingsandFacilities/ https://collaboration.fda.gov/common/ heading of this document. Received WhiteOakCampusInformation/ help/en/support/meeting_test.htm. To comments may be seen in the Division ucm241740.htm. get a quick overview of the Connect Pro of Dockets Management between 9 a.m. Contact Persons: Bahram Parvinian, program, visit http://www.adobe.com/ and 4 p.m., Monday through Friday, and Center for Devices and Radiological go/connectpro_overview. (FDA has VerDate Sep<11>2014 16:57 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1


Document Created: 2015-12-15 11:06:41
Document Modified: 2015-12-15 11:06:41
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; extension of comment period.
DatesFDA is extending the comment period on the document published May 19, 2015 (80 FR 28624). Submit either electronic or written comments on the draft guidance by November 16, 2015.
ContactDivision of Compliance, Center for Veterinary Medicine, Food and Drug Administration (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-402-7001, [email protected]
FR Citation80 FR 49247 
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