83 FR 2790 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2790-2792 | |
| FR Document | 2018-00915 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2790-2792] From the Federal Register Online [www.thefederalregister.org] [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.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 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
![2790 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
contact information to be made publicly Complying with FDA regulations and IEC 60825–1 Ed. 3 and IEC 60601–2–22
available, you can provide this conforming to the identified IEC Ed.3.1 (Laser Notice No. 56)’’ may send
information on the cover sheet and not standards may cause manufacturers to an email request to CDRH-Guidance@
in the body of your comments and you duplicate their efforts. fda.hhs.gov to receive an electronic
must identify this information as FDA acknowledges the advantages of copy of the document. Please use the
‘‘confidential.’’ Any information marked a universal set of device-specific criteria document number 1500024 to identify
as ‘‘confidential’’ will not be disclosed and requirements. Moreover, FDA the guidance you are requesting.
except in accordance with 21 CFR 10.20 believes that under the circumstances
described in this guidance, conformance IV. Paperwork Reduction Act of 1995
and other applicable disclosure law. For
more information about FDA’s posting with certain IEC standards would This draft guidance refers to
of comments to public dockets, see 80 provide adequate protection of the previously approved collections of
FR 56469, September 18, 2015, or access public health and safety for laser information found in FDA regulations.
the information at: https://www.gpo.gov/ products similar to FDA’s performance These collections of information are
fdsys/pkg/FR-2015-09-18/pdf/2015- standards in §§ 1040.10 and 1040.11 (21 subject to review by the Office of
23389.pdf. CFR 1040.10 and 1040.11). FDA Management and Budget (OMB) under
Docket: For access to the docket to eventually intends to amend its the Paperwork Reduction Act of 1995
read background documents or the standards for laser products at (44 U.S.C. 3501–3520). The collections
electronic and written/paper comments §§ 1040.10 and 1040.11 to harmonize of information in 21 CFR 1002.10,
received, go to https:// many of its requirements with those of 1010.2, 1010.3, 1040.10, and 1040.11
www.regulations.gov and insert the the IEC because FDA acknowledges the have been approved under OMB control
docket number, found in brackets in the advantages of one set of criteria and number 0910–0025.
heading of this document, into the requirements worldwide.
Dated: January 12, 2018.
‘‘Search’’ box and follow the prompts On June 24, 2007, FDA’s Center for
Devices and Radiological Health (CDRH) Leslie Kux,
and/or go to the Dockets Management
published a guidance entitled ‘‘Laser Associate Commissioner for Policy.
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Products—Conformance with IEC [FR Doc. 2018–00898 Filed 1–18–18; 8:45 am]
You may submit comments on any 60825–1 and IEC 60601–2–22; Guidance BILLING CODE 4164–01–P
guidance at any time (see 21 CFR for Industry and FDA Staff (Laser Notice
10115(g)(5)). No. 50)’’ (https://www.fda.gov/
An electronic copy of the guidance downloads/MedicalDevices/ DEPARTMENT OF HEALTH AND
document is available for download DeviceRegulationandGuidance/ HUMAN SERVICES
from the internet. See the GuidanceDocuments/ucm094366.pdf).
This draft guidance, when finalized, Food and Drug Administration
SUPPLEMENTARY INFORMATION section for
information on electronic access to the will not replace the recommendations [Docket No. FDA–2016–D–1309]
guidance. Submit written requests for a provided in that 2007 guidance, and
single hard copy of the draft guidance upon finalization of this guidance, Compounded Drug Products That Are
document entitled ‘‘Conformance with manufacturers can follow either Laser Essentially Copies of a Commercially
IEC 60825–1 Ed. 3 and IEC 60601–2–22 Notice No. 50 or this guidance. Available Drug Product Under Section
Ed.3.1 (Laser Notice No. 56)’’ to the II. Significance of Guidance 503A of the Federal Food, Drug, and
Office of the Center Director, Guidance Cosmetic Act; Guidance for Industry;
This draft guidance is being issued Availability
and Policy Development, Center for
consistent with FDA’s good guidance
Devices and Radiological Health, Food AGENCY: Food and Drug Administration,
practices regulation (21 CFR 10.115).
and Drug Administration, 10903 New HHS.
The draft guidance, when finalized, will
Hampshire Ave., Bldg. 66, Rm. 5431,
represent the current thinking of FDA ACTION: Notice of availability.
Silver Spring, MD 20993–0002. Send
on ‘‘Laser Products—Conformance with
one self-addressed adhesive label to SUMMARY: The Food and Drug
IEC 60825–1 Ed. 3 and IEC 60601–2–22
assist that office in processing your Administration (FDA or Agency) is
Ed.3.1 (Laser Notice No. 56)’’. It does
request. announcing the availability of a
not establish any rights for any person
FOR FURTHER INFORMATION CONTACT: and is not binding on FDA or the public. guidance for industry entitled
Patrick Hintz, Center for Devices and You can use an alternative approach if ‘‘Compounded Drug Products That Are
Radiological Health, Food and Drug it satisfies the requirements of the Essentially Copies of a Commercially
Administration, 10903 New Hampshire applicable statutes and regulations. This Available Drug Product Under Section
Ave., Bldg. 66, Rm. 4228, Silver Spring, guidance is not subject to Executive 503A of the Federal Food, Drug, and
MD 20993–0002, 301–796–6927. Order 12866. Cosmetic Act.’’ One of the conditions to
SUPPLEMENTARY INFORMATION: qualify for exemptions under section
III. Electronic Access 503A of the Federal Food, Drug, and
I. Background Persons interested in obtaining a copy Cosmetic Act (the FD&C Act), is that a
FDA recognizes that the IEC is a of the draft guidance may do so by drug product must be compounded by
global organization that prepares and downloading an electronic copy from a licensed pharmacist or physician who
publishes international standards for the internet. A search capability for all does not compound regularly or in
electrical, electronic, and related CDRH guidance documents is available inordinate amounts any drug products
daltland on DSKBBV9HB2PROD with NOTICES
technologies, including laser products. at https://www.fda.gov/MedicalDevices/ that are essentially copies of a
This means that manufacturers DeviceRegulationandGuidance/ commercially available drug product.
distributing products in the United GuidanceDocuments/default.htm. This This guidance sets forth FDA policies
States and other countries might have to guidance document is also available at regarding this provision of section
ensure conformance of their products https://www.regulations.gov. Persons 503A, including the terms
with IEC standards as well as comply unable to download an electronic copy ‘‘commercially available,’’ ‘‘essentially a
with FDA regulatory requirements. of ‘‘Laser Products—Conformance with copy of a commercially available drug
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![2792 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
In the Federal Register of July 11, conduct or sponsor. ‘‘Collection of (OMB) for review and clearance under
2016 (81 FR 44881), FDA issued a notice information’’ is defined in 44 U.S.C. the Paperwork Reduction Act of 1995.
announcing the availability of the draft 3502(3) and 5 CFR 1320.3 and includes DATES: Fax written comments on the
version of this guidance. The comment Agency requests or requirements that collection of information by February
period on the draft guidance ended on members of the public submit reports, 20, 2018.
October 11, 2016. FDA received keep records, or provide information to ADDRESSES: To ensure that comments on
approximately 88 comments on the draft a third party. Section 3506(c)(2)(A) of the information collection are received,
guidance. In response to received the PRA (44 U.S.C. 3506(c)(2)(A)) OMB recommends that written
comments or on its own initiative, FDA requires Federal Agencies to provide a comments be faxed to the Office of
made several changes. For example, in 60-day notice in the Federal Register Information and Regulatory Affairs,
response to requests in comments for concerning each proposed collection of OMB, Attn: FDA Desk Officer, Fax: 202–
direction on records retention, FDA information before submitting the 395–7285, or emailed to oira_
added a recommendation that collection to OMB for approval. To submission@omb.eop.gov. All
compounders maintain the records comply with this requirement, in the
comments should be identified with the
described in the guidance for a period Federal Register of July 11, 2016, we
OMB control number 0910—NEW and
of at least 3 years. In addition, to gave interested persons 60 days to
title ‘‘Guidance for Industry on
address questions raised in comments, comment on the information collection
Compounded Drug Products that are
FDA clarified that the policies in this provisions in the draft guidance (81 FR
Essentially Copies of a Commercially
guidance apply to a compounded drug 44881).
The information collection provisions Available Drug Product Under Section
product without regard to the source(s)
in this guidance have been submitted to 503A of the Federal Food, Drug, and
of the active pharmaceutical ingredient
OMB for review as required by section Cosmetic Act.’’ Also include the FDA
(API) in that product, for example, the
3507(d) of the PRA. These provisions docket number found in brackets in the
policies would apply regardless of
are not in effect until they display a heading of this document.
whether the compounder used an API
that was purchased as an isolate, or if currently valid OMB control number. FOR FURTHER INFORMATION CONTACT:
the compounder modified a finished FDA will publish a notice in the Federal Domini Bean, Office of Operations,
drug product containing an API. Register announcing OMB’s decision Food and Drug Administration, Three
FDA received comments on the draft regarding the information collection White Flint North, 10A–12M, 11601
guidance from hospital organizations provisions in this guidance. Landsdown St., North Bethesda, MD
regarding the potential implications of 20852, 301–796–5733, PRAStaff@
III. Electronic Access fda.hhs.gov.
the proposed policies in the draft
guidance for the preparation of Persons with access to the internet SUPPLEMENTARY INFORMATION: In
compounded drugs used in in-patient may obtain the guidance at either compliance with 44 U.S.C. 3507, FDA
settings. The final guidance notes that https://www.fda.gov/Drugs/ has submitted the following proposed
FDA is considering the applicability of GuidanceComplianceRegulatory collection of information to OMB for
the policies described in this guidance Information/Guidances/default.htm or review and clearance.
to hospitals and health systems. We https://www.regulations.gov.
recognize that this issue is of interest to Dated: January 16, 2018.
Guidance for Industry on Compounded
many stakeholders and will convey our Drug Products That Are Essentially
Leslie Kux,
further thinking on the applicability of Copies of a Commercially Available
Associate Commissioner for Policy.
these policies to hospitals and health Drug Product Under Section 503A of
[FR Doc. 2018–00915 Filed 1–18–18; 8:45 am] the Federal Food, Drug, and Cosmetic
systems publicly with an opportunity
BILLING CODE 4164–01–P Act
for comment.
This guidance is being issued OMB Control Number 0910—NEW
consistent with FDA’s good guidance
DEPARTMENT OF HEALTH AND This information collection supports
practices regulation (21 CFR 10.115).
HUMAN SERVICES the above captioned Agency guidance
This guidance represents the current
thinking of FDA on ‘‘Compounded Drug document. In the Federal Register of
Food and Drug Administration
Products That Are Essentially Copies of July 11, 2016 (81 FR 44881), FDA
a Commercially Available Drug Product [Docket No. FDA–2016–D–1309] announced the availability of a draft
Under Section 503A of the Federal guidance for industry entitled
Agency Information Collection ‘‘Guidance for Industry on Compounded
Food, Drug, and Cosmetic Act.’’ It does
Activities; Submission for Office of Drug Products That Are Essentially
not establish any rights for any person
Management and Budget Review; Copies of a Commercially Available
and is not binding on FDA or the public.
Comment Request; Guidance for Drug Product Under Section 503A of the
You can use an alternative approach if
Industry on Compounded Drug Federal Food, Drug, and Cosmetic Act,’’
it satisfies the requirements of the
Products That Are Essentially Copies and included an analysis of the
applicable statutes and regulations. This
of a Commercially Available Drug associated information collection.
guidance is not subject to Executive
Product Under Section 503A of the Section 503A of the Federal Food,
Order 12866.
Federal Food, Drug, and Cosmetic Act Drug, and Cosmetic Act (FD&C Act) (21
II. Paperwork Reduction Act of 1995 U.S.C. 353a) describes conditions that
AGENCY: Food and Drug Administration,
This guidance contains collections of HHS. must be met in order for compounded
daltland on DSKBBV9HB2PROD with NOTICES
information that are subject to review by ACTION: Notice. drugs to receive exemptions from
the Office of Management and Budget certain sections of the FD&C Act,
(OMB) under the Paperwork Reduction SUMMARY: The Food and Drug including section 501(a)(2)(B) (21 U.S.C.
Act (PRA) of 1995 (44 U.S.C. 3501– Administration (FDA) is announcing 351(a)(2)(B)) (concerning current good
3520). Under the PRA, Federal Agencies that a proposed collection of manufacturing practice for drugs);
must obtain approval from OMB for information has been submitted to the section 502(f)(1) (21 U.S.C. 352(f)(1))
each collection of information they Office of Management and Budget (concerning the labeling of drugs with
VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/83_FR_2803/page/3.svg)
Document Created: 2018-01-19 02:43:00
Document Modified: 2018-01-19 02:43:00
| 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 | The announcement of the guidance is published in the Federal Register on January 19, 2018. | |
| 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. | |
| FR Citation | 83 FR 2790 |
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