Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 2790-2792 [2018-00915]

Download as PDF 2790 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 10115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Conformance with IEC 60825–1 Ed. 3 and IEC 60601–2–22 Ed.3.1 (Laser Notice No. 56)’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: daltland on DSKBBV9HB2PROD with NOTICES Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993–0002, 301–796–6927. SUPPLEMENTARY INFORMATION: I. Background FDA recognizes that the IEC is a global organization that prepares and publishes international standards for electrical, electronic, and related technologies, including laser products. This means that manufacturers distributing products in the United States and other countries might have to ensure conformance of their products with IEC standards as well as comply with FDA regulatory requirements. VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 Complying with FDA regulations and conforming to the identified IEC standards may cause manufacturers to duplicate their efforts. FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. Moreover, FDA believes that under the circumstances described in this guidance, conformance with certain IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA’s performance standards in §§ 1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). FDA eventually intends to amend its standards for laser products at §§ 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide. On June 24, 2007, FDA’s Center for Devices and Radiological Health (CDRH) published a guidance entitled ‘‘Laser Products—Conformance with IEC 60825–1 and IEC 60601–2–22; Guidance for Industry and FDA Staff (Laser Notice No. 50)’’ (https://www.fda.gov/ downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm094366.pdf). This draft guidance, when finalized, will not replace the recommendations provided in that 2007 guidance, and upon finalization of this guidance, manufacturers can follow either Laser Notice No. 50 or this guidance. II. Significance of 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 ‘‘Laser Products—Conformance with IEC 60825–1 Ed. 3 and IEC 60601–2–22 Ed.3.1 (Laser Notice No. 56)’’. 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. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Laser Products—Conformance with PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 IEC 60825–1 Ed. 3 and IEC 60601–2–22 Ed.3.1 (Laser Notice No. 56)’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500024 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 1002.10, 1010.2, 1010.3, 1040.10, and 1040.11 have been approved under OMB control number 0910–0025. Dated: January 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–00898 Filed 1–18–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1309] Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms ‘‘commercially available,’’ ‘‘essentially a copy of a commercially available drug SUMMARY: E:\FR\FM\19JAN1.SGM 19JAN1 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices product,’’ and ‘‘regularly or in inordinate amounts.’’ DATES: The announcement of the guidance is published in the Federal Register on January 19, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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’’). daltland on DSKBBV9HB2PROD with NOTICES 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– 2016–D–1309 for ‘‘Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 2791 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 final guidance for industry entitled ‘‘Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ Section 503A (21 U.S.C. 353a), 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 new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503A of the FD&C Act is that it must be compounded by a licensed pharmacist or a licensed physician that does not compound regularly or in inordinate amounts (as defined by the Secretary of Health and Human Services) any drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D)). The statute further states that the term ‘‘essentially a copy of a commercially available drug product’’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product (section 503A(b)(2) of the FD&C Act). This guidance sets forth FDA’s policies concerning the ‘‘essentially a copy’’ provision under section 503A of the FD&C Act, including the terms ‘‘commercially available,’’ ‘‘essentially a copy of a commercially available drug product,’’ and ‘‘regularly or in inordinate amounts.’’ E:\FR\FM\19JAN1.SGM 19JAN1 2792 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES In the Federal Register of July 11, 2016 (81 FR 44881), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on October 11, 2016. FDA received approximately 88 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, in response to requests in comments for direction on records retention, FDA added a recommendation that compounders maintain the records described in the guidance for a period of at least 3 years. In addition, to address questions raised in comments, FDA clarified that the policies in this guidance apply to a compounded drug product without regard to the source(s) of the active pharmaceutical ingredient (API) in that product, for example, the policies would apply regardless of whether the compounder used an API that was purchased as an isolate, or if the compounder modified a finished drug product containing an API. FDA received comments on the draft guidance from hospital organizations regarding the potential implications of the proposed policies in the draft guidance for the preparation of compounded drugs used in in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to hospitals and health systems. We recognize that this issue is of interest to many stakeholders and will convey our further thinking on the applicability of these policies to hospitals and health systems publicly with an opportunity for comment. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on ‘‘Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ 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. Paperwork Reduction Act of 1995 This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501– 3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of July 11, 2016, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (81 FR 44881). The information collection provisions in this guidance have been submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB’s decision regarding the information collection provisions in this guidance. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–00915 Filed 1–18–18; 8:45 am] BILLING CODE 4164–01–P (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 20, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910—NEW and title ‘‘Guidance for Industry on Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910—NEW DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1309] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget SUMMARY: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 This information collection supports the above captioned Agency guidance document. In the Federal Register of July 11, 2016 (81 FR 44881), FDA announced the availability of a draft guidance for industry entitled ‘‘Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act,’’ and included an analysis of the associated information collection. Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes conditions that must be met in order for compounded drugs to receive exemptions from certain sections of the FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2790-2792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00915]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]

Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Compounded Drug
Products That Are Essentially Copies of a Commercially Available Drug
Product Under Section 503A of the Federal Food, Drug, and Cosmetic
Act.'' One of the conditions to qualify for exemptions under section
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is
that a drug product must be compounded by a licensed pharmacist or
physician who does not compound regularly or in inordinate amounts any
drug products that are essentially copies of a commercially available
drug product. This guidance sets forth FDA policies regarding this
provision of section 503A, including the terms ``commercially
available,'' ``essentially a copy of a commercially available drug

[[Page 2791]]

product,'' and ``regularly or in inordinate amounts.''

DATES: The announcement of the guidance is published in the Federal
Register on January 19, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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'').

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-2016-D-1309 for ``Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic Act.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at 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.gpo.gov/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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a final guidance for industry
entitled ``Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), 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 new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)).
One of the conditions that must be met for a compounded drug
product to qualify for the exemptions under section 503A of the FD&C
Act is that it must be compounded by a licensed pharmacist or a
licensed physician that does not compound regularly or in inordinate
amounts (as defined by the Secretary of Health and Human Services) any
drug products that are essentially copies of a commercially available
drug product (section 503A(b)(1)(D)).
The statute further states that the term ``essentially a copy of a
commercially available drug product'' does not include a drug product
in which there is a change, made for an identified individual patient,
which produces for that patient a significant difference, as determined
by the prescribing practitioner, between the compounded drug and the
comparable commercially available drug product (section 503A(b)(2) of
the FD&C Act).
This guidance sets forth FDA's policies concerning the
``essentially a copy'' provision under section 503A of the FD&C Act,
including the terms ``commercially available,'' ``essentially a copy of
a commercially available drug product,'' and ``regularly or in
inordinate amounts.''

[[Page 2792]]

In the Federal Register of July 11, 2016 (81 FR 44881), FDA issued
a notice announcing the availability of the draft version of this
guidance. The comment period on the draft guidance ended on October 11,
2016. FDA received approximately 88 comments on the draft guidance. In
response to received comments or on its own initiative, FDA made
several changes. For example, in response to requests in comments for
direction on records retention, FDA added a recommendation that
compounders maintain the records described in the guidance for a period
of at least 3 years. In addition, to address questions raised in
comments, FDA clarified that the policies in this guidance apply to a
compounded drug product without regard to the source(s) of the active
pharmaceutical ingredient (API) in that product, for example, the
policies would apply regardless of whether the compounder used an API
that was purchased as an isolate, or if the compounder modified a
finished drug product containing an API.
FDA received comments on the draft guidance from hospital
organizations regarding the potential implications of the proposed
policies in the draft guidance for the preparation of compounded drugs
used in in-patient settings. The final guidance notes that FDA is
considering the applicability of the policies described in this
guidance to hospitals and health systems. We recognize that this issue
is of interest to many stakeholders and will convey our further
thinking on the applicability of these policies to hospitals and health
systems publicly with an opportunity for comment.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Compounded Drug Products That Are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' 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. Paperwork Reduction Act of 1995

This guidance contains collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). Under the
PRA, Federal Agencies must obtain approval from OMB for each collection
of information they conduct or sponsor. ``Collection of information''
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, in the
Federal Register of July 11, 2016, we gave interested persons 60 days
to comment on the information collection provisions in the draft
guidance (81 FR 44881).
The information collection provisions in this guidance have been
submitted to OMB for review as required by section 3507(d) of the PRA.
These provisions are not in effect until they display a currently valid
OMB control number. FDA will publish a notice in the Federal Register
announcing OMB's decision regarding the information collection
provisions in this guidance.

III. Electronic Access

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

Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00915 Filed 1-18-18; 8:45 am]
BILLING CODE 4164-01-P

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