83 FR 2787 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; 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 | 2787-2789 | |
| FR Document | 2018-00916 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2787-2789] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00916] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1525] Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. DATES: The announcement of the guidance is published in the Federal Register on January 19, 2018. ADDRESSES: You may submit 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 [[Page 2788]] 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-2014-D-1525 for ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' 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 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 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Avenue, 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: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796- 3110; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a final guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' Certain licensed biological products may sometimes be mixed, diluted, or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. For example, for some biological products there is no licensed pediatric strength and/or dosage form. In addition, there may be certain circumstances when a person would remove a licensed biological product from its original container and place it into a different container(s) (repackage it), in a manner that is not within the scope of the approved labeling for the product. As described in the guidance, mixed, diluted, or repackaged biological products are not eligible for the statutory exemptions available to certain compounded drugs under sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). In addition, a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is considered an unlicensed biological product under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). This guidance describes the conditions under which FDA does not intend to take action for violations of section 351 of the PHS Act, and section 502(f)(1) (21 U.S.C. 352(f)(1)), section 582 (21 U.S.C. 360eee- 1), and where specified, section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) of the FD&C Act, when a state-licensed pharmacy, a Federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA. In the Federal Register of January 13, 2017 (82 FR 4358), FDA issued a notice announcing the availability of the revised draft version of this guidance. The comment period on the draft guidance ended on March 14, 2017. FDA received 11 comments on the revised draft guidance. In response to received comments or on its own initiative, FDA made revisions to clarify certain points. For example, FDA added a footnote indicating that the Agency is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance. FDA also clarified that one of the conditions under which the Agency does not intend to take action for the violations listed above is that any components used in mixing or diluting a licensed biological product are sterile, pharmaceutical grade, and otherwise appropriate for such use. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on mixing, diluting, or repackaging biological products outside [[Page 2789]] the scope of an approved BLA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. 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 January 13, 2017, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (82 FR 4358 at 4359). The information collection provisions in this guidance will be 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. The guidance also references registration and adverse event reporting for outsourcing facilities. The collections of information for outsourcing facility registration have been approved by OMB under OMB control number 0910-0777. The collections of information for adverse event reporting by outsourcing facilities have been approved by OMB under OMB control number 0910-0800. III. Electronic Access Persons with access to the internet may obtain the 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: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00916 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2787
• Section 505 (21 U.S.C. 355) policies for the preparation of Guidances/default.htm or https://
(concerning the approval of drugs under compounded drugs used in in-patient www.regulations.gov.
new drug applications or abbreviated settings. The final guidance notes that Dated: January 16, 2018.
new drug applications); and FDA is considering the applicability of Leslie Kux,
• Section 582 (21 U.S.C. 360eee–1) the policies described in this guidance
(concerning drug supply chain security Associate Commissioner for Policy.
to hospitals and health systems. We
requirements). recognize that this issue is of interest to [FR Doc. 2018–00914 Filed 1–18–18; 8:45 am]
One of the conditions that must be many stakeholders and will publicly BILLING CODE 4164–01–P
met for a compounded drug product to convey our further thinking on the
qualify for the exemptions under section applicability of these policies to
503B of the FD&C Act is that the drug hospitals and health systems with an DEPARTMENT OF HEALTH AND
is not essentially a copy of one or more opportunity for comment. HUMAN SERVICES
approved drugs (section 503B(a)(5)). This guidance is being issued
Section 503B(d)(2) defines essentially Food and Drug Administration
consistent with FDA’s good guidance
a copy of an approved drug as: practices regulation (21 CFR 10.115). [Docket No. FDA–2014–D–1525]
• A drug that is identical or nearly This guidance represents the current
identical to an approved drug, or a thinking of FDA on ‘‘Compounded Drug Mixing, Diluting, or Repackaging
marketed drug not subject to section Products That Are Essentially Copies of Biological Products Outside the Scope
503(b) and not subject to approval in an Approved Drug Products Under Section of an Approved Biologics License
application submitted under section 503B of the Federal Food, Drug, and Application; Guidance for Industry;
505, unless, in the case of an approved Cosmetic Act.’’ It does not establish any Availability
drug, the drug appears on the drug rights for any person and is not binding
shortage list in effect under section 506E AGENCY: Food and Drug Administration,
on FDA or the public. You can use an HHS.
at the time of compounding, alternative approach if it satisfies the
distribution, and dispensing (section requirements of the applicable statutes ACTION: Notice of availability.
503B(d)(2)(A)) or and regulations. This guidance is not
• a drug, a component of which is a SUMMARY: The Food and Drug
subject to Executive Order 12866. Administration (FDA or the Agency) is
bulk drug substance that is a component
of an approved drug or a marketed drug II. Paperwork Reduction Act of 1995 announcing the availability of a final
that is not subject to section 503(b) and guidance for industry entitled ‘‘Mixing,
This guidance contains collections of
not subject to approval in an application Diluting, or Repackaging Biological
information that are subject to review by
submitted under section 505, unless Products Outside the Scope of an
OMB under the PRA (44 U.S.C. 3501–
there is a change that produces for an Approved Biologics License
3520). Under the PRA, Federal Agencies
individual patient a clinical difference, Application.’’ This final guidance
must obtain approval from OMB for
as determined by the prescribing describes the conditions under which
each collection of information they
practitioner, between the compounded FDA does not intend to take action
conduct or sponsor. ‘‘Collection of
drug and the comparable approved drug against a State-licensed pharmacy, a
information’’ is defined in 44 U.S.C.
(section 503B(d)(2)(B)). Federal facility, or an outsourcing
3502(3) and 5 CFR 1320.3 and includes
This guidance sets forth FDA’s facility that mixes, dilutes, or
Agency requests or requirements that
policies concerning the ‘‘essentially a repackages certain biological products
members of the public submit reports,
copy’’ provision of section 503B of the outside the scope of an approved
keep records, or provide information to
FD&C Act. biologics license application (BLA). It
a third party. Section 3506(c)(2)(A) of
In the Federal Register of July 11, also describes the conditions under
the PRA (44 U.S.C. 3506(c)(2)(A))
2016 (81 FR 44879), FDA issued a notice which FDA does not intend to take
requires Federal Agencies to provide a
announcing the availability of the draft action when a State-licensed pharmacy,
60-day notice in the Federal Register
version of this guidance. The comment a Federal facility, an outsourcing
concerning each proposed collection of
period on the draft guidance ended on facility, or a physician prepares
information before submitting the
October 11, 2016. FDA received 29 prescription sets of allergenic extracts
collection to OMB for approval. To
comments on the draft guidance. In for subcutaneous immunotherapy.
comply with this requirement, in the
response to received comments or on its Federal Register of July 11, 2016, we DATES: The announcement of the
own initiative, FDA made several gave interested persons 60 days to guidance is published in the Federal
changes. For example, in response to comment on the information collection Register on January 19, 2018.
requests in comments for direction on provisions in the draft guidance. ADDRESSES: You may submit electronic
records retention, FDA added a The information collection provisions or written comments on Agency
recommendation that compounders in this guidance have been submitted to guidances at any time as follows:
maintain the records described in the OMB for review as required by section
guidance for at least 3 years. In addition, Electronic Submissions
3507(d) of the PRA. These provisions
to address questions raised in are not in effect until they display a Submit electronic comments in the
comments, FDA clarified that the currently valid OMB control number. following way:
Agency does not intend to take action FDA will publish a notice in the Federal • Federal eRulemaking Portal:
against an outsourcing facility for failing Register announcing OMB’s decision https://www.regulations.gov. Follow the
to compound in accordance with regarding the information collection instructions for submitting comments.
daltland on DSKBBV9HB2PROD with NOTICES
section 503B(a)(5) if it fills orders for a provisions in this guidance. Comments submitted electronically,
compounded drug that is essentially a including attachments, to https://
copy of an approved drug that has been III. Electronic Access www.regulations.gov will be posted to
discontinued and is no longer marketed. Persons with access to the internet the docket unchanged. Because your
FDA received comments from may obtain the guidance at either comment will be made public, you are
hospital organizations regarding the https://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your
potential implications of proposed ComplianceRegulatoryInformation/ comment does not include any
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![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2789
the scope of an approved BLA. It does Dated: January 16, 2018. solely responsible for ensuring that your
not establish any rights for any person Leslie Kux, comment does not include any
and is not binding on FDA or the public. Associate Commissioner for Policy. confidential information that you or a
You can use an alternative approach if [FR Doc. 2018–00916 Filed 1–18–18; 8:45 am] third party may not wish to be posted,
it satisfies the requirements of the BILLING CODE 4164–01–P such as medical information, your or
applicable statutes and regulations. anyone else’s Social Security number, or
confidential business information, such
II. Paperwork Reduction Act of 1995 as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND
This guidance contains collections of HUMAN SERVICES that if you include your name, contact
information that are subject to review by information, or other information that
the Office of Management and Budget Food and Drug Administration identifies you in the body of your
(OMB) under the Paperwork Reduction [Docket No. FDA–2017–D–7011] comments, that information will be
Act (PRA) of 1995 (44 U.S.C. 3501– posted on https://www.regulations.gov.
3520). Under the PRA, Federal Agencies Laser Products—Conformance With • If you want to submit a comment
must obtain approval from OMB for IEC 60825–1 Ed. 3 and IEC 60601–2–22 with confidential information that you
each collection of information they Ed. 3.1 (Laser Notice No. 56); Draft do not wish to be made available to the
conduct or sponsor. ‘‘Collection of Guidance for Industry and Food and public, submit the comment as a
information’’ is defined in 44 U.S.C. Drug Administration Staff; Availability written/paper submission and in the
3502(3) and 5 CFR 1320.3 and includes manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
Agency requests or requirements that
HHS.
members of the public submit reports, Written/Paper Submissions
keep records, or provide information to ACTION: Notice of availability.
Submit written/paper submissions as
a third party. Section 3506(c)(2)(A) of SUMMARY: The Food and Drug follows:
the PRA (44 U.S.C. 3506(c)(2)(A)) Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
requires Federal Agencies to provide a announcing the availability of the draft written/paper submissions): Dockets
60-day notice in the Federal Register guidance entitled ‘‘Conformance with Management Staff (HFA–305), Food and
concerning each proposed collection of IEC 60825–1 Ed. 3 and IEC 60601–2–22 Drug Administration, 5630 Fishers
information before submitting the Ed. 3.1 (Laser Notice No. 56).’’ This Lane, Rm. 1061, Rockville, MD 20852.
collection to OMB for approval. To draft guidance describes the Agency’s • For written/paper comments
comply with this requirement, in the proposed approach regarding submitted to the Dockets Management
Federal Register of January 13, 2017, we compliance with FDA’s performance Staff, FDA will post your comment, as
gave interested persons 60 days to standards for laser products. FDA well as any attachments, except for
comment on the information collection believes that under the circumstances information submitted, marked and
provisions in the draft guidance (82 FR described in this guidance, conformance identified, as confidential, if submitted
4358 at 4359). with certain International as detailed in ‘‘Instructions.’’
The information collection provisions Electrotechnical Commission (IEC) Instructions: All submissions received
in this guidance will be submitted to standards would provide adequate must include the Docket No. FDA–
OMB for review as required by section protection of the public health and 2017–D–7011 for ‘‘Conformance with
3507(d) of the PRA. These provisions safety for laser products similar to IEC 60825–1 Ed. 3 and IEC 60601–2–22
are not in effect until they display a performance standards in FDA’s Ed.3.1 (Laser Notice No. 56).’’ Received
currently valid OMB control number. regulations. Accordingly, FDA does not comments will be placed in the docket
FDA will publish a notice in the Federal intend to consider whether firms that and, except for those submitted as
Register announcing OMB’s decision comply with the comparable IEC ‘‘Confidential Submissions,’’ publicly
regarding the information collection standards discussed in this guidance viewable at https://www.regulations.gov
provisions in this guidance. document also comply with or at the Dockets Management Staff
The guidance also references performance standards in FDA’s between 9 a.m. and 4 p.m., Monday
registration and adverse event reporting regulations. This draft guidance is not through Friday.
for outsourcing facilities. The final nor is it in effect at this time. • Confidential Submissions—To
collections of information for DATES: Submit either electronic or submit a comment with confidential
outsourcing facility registration have written comments on the draft guidance information that you do not wish to be
been approved by OMB under OMB by March 20, 2018 to ensure that the made publicly available, submit your
control number 0910–0777. The Agency considers your comment on this comments only as a written/paper
collections of information for adverse draft guidance before it begins work on submission. You should submit two
event reporting by outsourcing facilities the final version of the guidance. copies total. One copy will include the
have been approved by OMB under ADDRESSES: You may submit comments information you claim to be confidential
OMB control number 0910–0800. on any guidance at any time as follows: with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
III. Electronic Access Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Persons with access to the internet Submit electronic comments in the Agency will review this copy, including
may obtain the guidance at either following way: the claimed confidential information, in
https://www.fda.gov/Drugs/ • Federal eRulemaking Portal: its consideration of comments. The
daltland on DSKBBV9HB2PROD with NOTICES
GuidanceComplianceRegulatory https://www.regulations.gov. Follow the second copy, which will have the
Information/Guidances/default.htm, instructions for submitting comments. claimed confidential information
https://www.fda.gov/Biologics Comments submitted electronically, redacted/blacked out, will be available
BloodVaccines/GuidanceCompliance including attachments, to https:// for public viewing and posted on
RegulatoryInformation/Guidances/ www.regulations.gov will be posted to https://www.regulations.gov. Submit
default.htm, or https:// the docket unchanged. Because your both copies to the Dockets Management
www.regulations.gov. comment will be made public, you are Staff. If you do not wish your name and
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Document Created: 2018-01-19 02:42:52
Document Modified: 2018-01-19 02:42:52
| 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 20903, 301-796- 3110; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 2787 |
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