82 FR 60403 - Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range		60403-60405
FR Document		2017-27157

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017)

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60403-60405]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-27157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6580]

Drug Products Labeled as Homeopathic; Draft Guidance for Food and
Drug Administration Staff and Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for FDA staff and industry
entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance
describes how FDA intends to prioritize enforcement and regulatory
action with regard to drug products, including biological products,
labeled as homeopathic and marketed in the United States without the
required FDA approval.

DATES: Submit either electronic or written comments on the draft
guidance by March 20, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 60404]]

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-D-6580 for ``Drug Products Labeled as Homeopathic.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-
3600; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for FDA
staff and industry entitled ``Drug Products Labeled as Homeopathic.''
This draft guidance describes how FDA intends to prioritize enforcement
and regulatory action with regard to drug products, including
biological products, labeled as homeopathic and marketed in the United
States without the required FDA approval. Simultaneous with the
issuance of the final guidance, FDA will withdraw Compliance Policy
Guide (CPG) 400.400, ``Conditions Under Which Homeopathic Drugs May be
Marketed'', issued on May 31, 1988.
Homeopathy is an alternative medical practice that has an
historical basis in theory and practice first systematized in the late
1700s. Homeopathy is generally based on two main principles: (1) A
substance that causes symptoms in a healthy person can be used in
diluted form to treat symptoms and illnesses (known as ``like-cures-
like'') and (2) the more diluted the substance, the more potent it is
(known as the ``law of infinitesimals'').
The definition of ``drug'' in section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1))
includes articles recognized in the Homeopathic Pharmacopoeia of the
United States (HPUS) or any supplement to it. As such, homeopathic
drugs are subject to the same regulatory requirements as other drugs.
Generally, a drug, including a homeopathic drug, is considered a ``new
drug'' if it is not generally recognized by qualified experts as safe
and effective (GRAS/E) for its labeled uses (section 201(p) of the FD&C
Act). FDA makes GRAS/E determinations for over-the-counter (OTC) drugs
marketed under the OTC Drug Review (see 21 CFR part 330). FDA has not
reviewed any drug products labeled as homeopathic under the OTC Drug
Review because the Agency categorized these products as a separate
category and deferred consideration of them (37 FR 9464 at 9466 (May
11, 1972)). Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)),
before any ``new drug'' is marketed, it must be the subject of an
approved application submitted pursuant to section 505(b) or section
505(j) of the FD&C Act; however, a biological product with an approved
license under section 351(a) of the Public Health Service Act (PHS Act)
(42 U.S.C. 262(a)) is not required to have an approved application
under section 505 of the FD&C Act. Accordingly, absent a determination
that a drug product labeled as homeopathic is not a ``new drug'' under
section 201(p), all drug products labeled as homeopathic are subject to
the premarket approval requirements in section 505 of the FD&C Act or
section 351 of the PHS Act. There are no drug products labeled as
homeopathic that are approved by FDA.
In May 1988, FDA's Center for Drug Evaluation and Research issued
CPG 400.400 entitled ``Conditions Under Which Homeopathic Drugs May be
Marketed.'' As stated in the 1988 CPG, it delineates the conditions,
including conditions related to ingredients, labeling, prescription
status, and current good manufacturing practice, under which
homeopathic drug products may ordinarily be marketed.
In light of the growth of the industry and passage of more than 2
decades since the 1988 CPG's issuance, FDA announced on March 27, 2015,
that it was evaluating its regulatory framework for these products. In
April 2015, FDA held a public hearing to obtain information and
comments from stakeholders about the current use of drug products
labeled as homeopathic, as well as the Agency's regulatory

[[Page 60405]]

framework for such products (Docket No. FDA-2015-N-0540; available at
https://www.regulations.gov/docket?D=FDA-2015-N-0540). FDA sought broad
public input on its enforcement policies related to drug products
labeled as homeopathic in an effort to better promote and protect the
public health.
As a result of the Agency's evaluation, including consideration of
the public input received on this issue, FDA has determined that it is
in the best interest of public health to issue a new guidance that
applies a risk-based enforcement approach to drug products labeled as
homeopathic and marketed in the United States without the required FDA
approval, consistent with FDA's risk-based regulatory approaches
generally. The Agency generally intends to apply a risk-based
enforcement approach to the manufacturing, distribution, and marketing
of drug products labeled as homeopathic, as described in the draft
guidance, when finalized. However, the Agency has limited enforcement
resources and recognizes that many such products likely will fall
outside the risk-based categories described in the draft guidance.
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 drug products
labeled as homeopathic. 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. This guidance is not subject to Executive Order 12866.

II. Electronic Access

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

Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27157 Filed 12-18-17; 11:15 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices 60405

framework for such products (Docket DEPARTMENT OF HEALTH AND this public comment request containing
No. FDA–2015–N–0540; available at HUMAN SERVICES any routine notice about the
https://www.regulations.gov/docket?D= confidentiality of the communication
FDA-2015-N-0540). FDA sought broad Agency Information Collection will be treated as public comments that
public input on its enforcement policies Activities: Proposed Collection; may be made available to the public
related to drug products labeled as Comment Request; Generic Clearance notwithstanding the inclusion of the
homeopathic in an effort to better for the Collection of Qualitative routine notice.
promote and protect the public health. Feedback on Agency Service Delivery FOR FURTHER INFORMATION CONTACT:
AGENCY: U.S. Department of Health and Sherrette Funn, Sherrrette.funn@
As a result of the Agency’s evaluation, HHS.GOV or (202) 795–7714.
including consideration of the public Human Services.
SUPPLEMENTARY INFORMATION:
input received on this issue, FDA has ACTION: 30-Day Day Notice template for
Title: Generic Clearance for the
determined that it is in the best interest Request for Generic Clearance for the
Collection of Qualitative Feedback on
of public health to issue a new guidance Collection of Routine Customer
Agency Service Delivery.
that applies a risk-based enforcement Feedback on (HITRC). Abstract: The proposed information
approach to drug products labeled as AGENCY: U.S. Department of Health and collection activity provides a means to
homeopathic and marketed in the Human Services (HHS). garner qualitative customer and
United States without the required FDA stakeholder feedback in an efficient,
ACTION: Notice and request for
approval, consistent with FDA’s risk- timely manner, in accordance with the
comments. Office of the National
based regulatory approaches generally. Administration’s commitment to
Coordinator for Health Information
The Agency generally intends to apply improving service delivery. By
Technology is requesting OMB approval
a risk-based enforcement approach to qualitative feedback we mean
for an extension on the Generic
the manufacturing, distribution, and information that provides useful
Clearance for the Collection of Routine
marketing of drug products labeled as insights on perceptions and opinions,
Customer Feedback by OMB.
homeopathic, as described in the draft but are not statistical surveys that yield
guidance, when finalized. However, the SUMMARY: Department of Health and quantitative results that can be
Agency has limited enforcement Human Services, The Office of the generalized to the population of study.
Secretary (OS), as part of its continuing This feedback will provide insights into
resources and recognizes that many
effort to reduce paperwork and customer or stakeholder perceptions,
such products likely will fall outside the
respondent burden, invites the general experiences and expectations, provide
risk-based categories described in the an early warning of issues with service,
draft guidance. public to take this opportunity to
comment on the ‘‘Generic Clearance for or focus attention on areas where
This draft guidance is being issued the Collection of Qualitative Feedback communication, training or changes in
consistent with FDA’s good guidance on Agency Service Delivery’’ for operations might improve delivery of
practices regulation (21 CFR 10.115). approval under the Paperwork products or services. These collections
The draft guidance, when finalized, will Reduction Act (PRA). This collection will allow for ongoing, collaborative and
represent the current thinking of FDA was developed as part of a Federal actionable communications between the
on drug products labeled as Government-wide effort to streamline Agency and its customers and
homeopathic. It does not establish any the process for seeking feedback from stakeholders. It will also allow feedback
rights for any person and is not binding the public on service delivery. This to contribute directly to the
on FDA or the public. You can use an notice announces our intent to submit improvement of program management.
The solicitation of feedback will target
alternative approach if it satisfies the this collection to OMB for approval and
areas such as: Timeliness,
requirements of the applicable statutes solicits comments on specific aspects
appropriateness, accuracy of
and regulations. This guidance is not for the proposed information collection.
information, courtesy, efficiency of
subject to Executive Order 12866. DATES: Consideration will be given to all service delivery, and resolution of
comments received by January 19, 2018. issues with service delivery. Responses
II. Electronic Access
ADDRESSES: Submit comments by one of will be assessed to plan and inform
Persons with access to the internet the following methods: efforts to improve or maintain the
may obtain the draft guidance at either • Website: www.regulations.gov. quality of service offered to the public.
https://www.fda.gov/Drugs/Guidance Direct comments to Docket ID OMB– If this information is not collected, vital
ComplianceRegulatoryInformation/ 2010–0021. feedback from customers and
Guidances/default.htm, https:// • Email: stakeholders on the Agency’s services
Information.CollectionClearance@ will be unavailable.
www.fda.gov/BiologicsBloodVaccines/
hhs.gov. The Agency will only submit a
GuidanceComplianceRegulatory
• Phone: (202) 795–7714. collection for approval under this
Information/Guidances/default.htm, or Comments submitted in response to
https://www.regulations.gov. generic clearance if it meets the
this notice may be made available to the following conditions:
Dated: December 6, 2017. public through relevant websites. For • The collections are voluntary;
Leslie Kux, this reason, please do not include in • The collections are low-burden for
Associate Commissioner for Policy. your comments information of a respondents (based on considerations of
confidential nature, such as sensitive
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2017–27157 Filed 12–18–17; 11:15 am]
total burden hours, total number of
personal information or proprietary respondents, or burden-hours per
BILLING CODE 4164–01–P
information. If you send an email respondent) and are low-cost for both
comment, your email address will be the respondents and the Federal
automatically captured and included as Government;
part of the comment that is placed in the • The collections are non-
public docket and made available on the controversial and do not raise issues of
internet. Please note that responses to concern to other Federal agencies;

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Document Created: 2018-10-25 10:55:17
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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		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796- 3600; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
FR Citation		82 FR 60403

82 FR 60403 - Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 243 (December 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration