82 FR 4343 - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4343-4345 | |
| FR Document | 2017-00723 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4343-4345] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00723] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1524] Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final 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 ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 4344]] Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-1524 for ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the 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 ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' FDA regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug. If a drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another ingredient, that act is not considered repackaging. Repackaged drugs are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs. For example, repackaged drugs are generally subject to the premarket approval, misbranding, adulteration, and drug supply chain security provisions of the FD&C Act, including section 505 (concerning new drug applications), section 502(f)(1) (concerning labeling with adequate directions for use), section 501(a)(2)(B) (concerning current good manufacturing practice (CGMP)), and section 582 (drug supply chain security requirements) (21 U.S.C. 355, 352(f)(1), 351(a)(2)(B), and 360eee-1). Further, drugs that are repackaged are not subject to sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). Therefore, drugs repackaged by state-licensed pharmacies, Federal facilities, or outsourcing facilities are not eligible for the exemptions provided under those sections. This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(1), 582, and, where specified in the guidance, section 501(a)(2)(B) of the FD&C Act, when a state-licensed pharmacy, Federal facility, or outsourcing facility repackages certain drug products. In the Federal Register of February 19, 2015 (80 FR 8884), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on May 20, 2015. FDA received approximately 625 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. For example, FDA removed from the guidance the condition concerning ``anticipatory repackaging'' (repackaging before the receipt of a patient-specific prescription) of no more than a 14-day supply. FDA made this change partly in response to comments indicating that pharmacies sometimes need to repackage more than a 14- day supply of repackaged drug products in advance of a prescription. FDA also revised the conditions concerning beyond-use-dates (BUDs) for repackaged drugs to reflect BUDs for compounded drugs in, as applicable, United States Pharmacopeia (USP) Chapter <795>, the USP's proposed revision to Chapter <797>, and FDA's guidance concerning current good manufacturing practice requirements for outsourcing facilities. FDA received comments on the draft guidance from hospital organizations regarding the potential implications of the proposed policies in the draft guidance concerning patient-specific prescriptions for drugs repackaged for in-patient settings. The final guidance notes that FDA is considering the applicability of the policies described in this guidance to in-patient settings, including long-term care facilities and hospitals, and intends to address these issues in separate guidance. 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 repackaging human drug products by pharmacies, Federal facilities, and outsourcing facilities. 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. [[Page 4345]] 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 February 19, 2015, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (80 FR 8884 at 8885). After publishing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, we will be submitting a proposed collection of information to OMB for review and clearance. FDA is issuing this guidance as final with portions of it subject to OMB approval of the collection of information and shaded gray. Those provisions that are shaded gray and subject to OMB approval will be final if the collection of information is approved. If the collection is approved, FDA will publish a notice in the Federal Register concerning OMB approval and providing an OMB control number for these provisions. 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 can obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: January 10, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00723 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4343
not reached, each party may use its statutory next LMC meeting. The formal agenda will be DEPARTMENT OF HEALTH AND
and other rights as specified in the distributed to all LMC members at least three HUMAN SERVICES
‘‘Preservation of Rights’’ section below. This work days prior to the next LMC meeting. For
decision making process will be evaluated by issues requiring a decision by the LMC, all Food and Drug Administration
the Committee after one full year of its proposals or related materials will be
operation. distributed to the LMC members as soon as
Meeting Schedule and Logistics: The possible but no later than seven work days [Docket No. FDA–2014–D–1524]
Committee will meet on a quarterly basis or prior to the meeting at which the decision
more frequently by consensus of its members. will need to be made. Repackaging of Certain Human Drug
The Committee will normally meet at ACF Communication: Final, approved minutes Products by Pharmacies and
Central Office in Washington, DC, but may of the Committee will be disseminated and Outsourcing Facilities; Final Guidance
also meet at another location by consensus. made available to all ACF employees via for Industry; Availability
If a Committee member is unable to methods determined by the Committee.
physically attend a meeting, he/she may Evaluation AGENCY: Food and Drug Administration,
participate by phone or video HHS.
teleconferencing. The date and time for any The Committee will evaluate its progress
meetings will be established by mutual on an annual basis. It will determine whether ACTION: Notice of availability.
agreement. Committee meetings may be held to renew its procedures and/or to make
in conjunction with other meetings where it changes in any aspect of the LMC. SUMMARY: The Food and Drug
is deemed cost effective and there is Preservation of Rights Administration (FDA or the Agency) is
consensus. announcing the availability of a final
Cooperation is not intended to supplant
Working Groups: The Committee has the
the decision-making authority, or to usurp
guidance for industry entitled
authority to form workgroups that may ‘‘Repackaging of Certain Human Drug
the responsibility of agency management, but
include individuals who are not members of Products by Pharmacies and
to further involve ACF employees in
the Committee. Any such workgroups will be Outsourcing Facilities.’’ This guidance
developing ACF decisions through the active
given their charge and/or responsibilities
from the LMC in writing. Non-Committee
and systematic participation of NTEU and describes the conditions under which
those it represents who perform ACF’s work. FDA does not intend to take action for
member bargaining unit participants on such This LMC is based on the belief that NTEU
groups will be appointed by NTEU and will violations of certain provisions of the
participation in ACF decision-making will Federal Food, Drug, and Cosmetic Act
be provided appropriate official time to promote decisions of such a nature that the
participate in workgroup activities. need for formal bargaining will be reduced (the FD&C Act), when a State-licensed
Support: The Committee will use the and, where bargaining becomes necessary, pharmacy, a Federal facility, or an
services of a facilitator trained in interest- will inform and facilitate the negotiations. outsourcing facility repackages certain
based bargaining techniques as needed. The Accordingly, subject to statute, executive human drug products.
appointed Executive Secretary will provide orders, and the collective bargaining
administrative support to the Committee. DATES: Submit either electronic or
agreement, ACF reserves the right to
Such support shall include creation and determine whether to implement written comments on Agency guidances
dissemination of meeting agenda and recommendations arising from the at any time.
minutes, announcements of meetings, and cooperation endeavor, and NTEU reserves ADDRESSES: You may submit comments
other matters as determined by the the right to bargain concerning the substance, as follows:
Committee. The Agency will make available impact and implementation of final ACF
the use of video and telephone conferencing decisions prior to implementation. The ACF Electronic Submissions
for the participation of all committee recognizes its statutory, regulatory, and/or
members at meetings. The Agency will contractual obligations to provide Submit electronic comments in the
provide meeting rooms for LMC meetings. notification to NTEU and to bargain. following way:
Participation: The Agency encourages the • Federal eRulemaking Portal: http://
use of video and telephone conferencing for Effective Date, Duration, and Modifications www.regulations.gov. Follow the
the participation of those members who are This LMC shall be instituted upon the date instructions for submitting comments.
domiciled outside the 50 mile radius of the parties have signed the Charter. The Comments submitted electronically,
Washington, DC, and will provide the partners may amend or supplement this
including attachments, to http://
necessary equipment to facilitate the process. Agreement at any time upon consensus. This
Union representatives will be granted official Agreement may be terminated by either of www.regulations.gov will be posted to
time for preparation and participation in the the parties to this Agreement. Termination by the docket unchanged. Because your
meetings, pursuant to Article 10 of the either party shall be provided in writing and comment will be made public, you are
Collective Bargaining Agreement. The shall be considered effective exactly 30 solely responsible for ensuring that your
Agency will pay for all reasonable local calendar days after receipt by the recipient comment does not include any
travel expenses, namely transportation and party. Notification of termination shall be confidential information that you or a
parking. For those participants domiciled sent out in a written notice to all ACF staff third party may not wish to be posted,
outside the 50 mile radius, the Agency agrees within 10 days of the termination and shall
such as medical information, your or
to reimburse the Union representatives 50 be published in the Federal Register within
30 days of the termination. anyone else’s Social Security number, or
percent of reasonable travel expenses,
including transportation, lodging, and per On behalf of NTEU and ACF, the confidential business information, such
diem. undersigned execute this Agreement on this as a manufacturing process. Please note
In the interest of facilitating the working 30th day of December, 2016, by Anthony that if you include your name, contact
relations among the members, the Agency Reardon, NTEU National President; Mark H. information, or other information that
agrees to assume the full costs associated Greenberg, Acting Assistant Secretary for identifies you in the body of your
with travel, including transportation, lodging Children and Families; and Benjamin comments, that information will be
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and per diem for participants for the first Goldhaber, Deputy Assistant Secretary for
posted on http://www.regulations.gov.
Administration, Administration for Children
scheduled meeting of the Committee. For all
and Families. • If you want to submit a comment
subsequent meetings, the Agency will
with confidential information that you
reimburse the Union representatives for 50 Dated: January 6, 2017.
percent as stated above. do not wish to be made available to the
Mark H. Greenberg, public, submit the comment as a
Agenda Development and Dissemination:
Assistant Secretary for Children and Families. written/paper submission and in the
The LMC’s potential agenda items will be
submitted to the Co-Chairs who will [FR Doc. 2017–00655 Filed 1–12–17; 8:45 am] manner detailed (see ‘‘Written/Paper
mutually establish a formal agenda for the BILLING CODE 4184–01–P Submissions’’ and ‘‘Instructions’’).
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![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4345
II. Paperwork Reduction Act of 1995 Dated: January 10, 2017. Electronic Submissions
This guidance contains collections of Leslie Kux, Submit electronic comments in the
information that are subject to review by Associate Commissioner for Policy. following way:
the Office of Management and Budget [FR Doc. 2017–00723 Filed 1–12–17; 8:45 am] • Federal eRulemaking Portal:
(OMB) under the Paperwork Reduction BILLING CODE 4164–01–P https://www.regulations.gov. Follow the
Act (PRA) of 1995 (44 U.S.C. 3501– instructions for submitting comments.
3520). Under the PRA, Federal Agencies Comments submitted electronically,
must obtain approval from OMB for DEPARTMENT OF HEALTH AND including attachments, to https://
each collection of information they HUMAN SERVICES www.regulations.gov will be posted to
conduct or sponsor. ‘‘Collection of the docket unchanged. Because your
Food and Drug Administration
information’’ is defined in 44 U.S.C. comment will be made public, you are
3502(3) and 5 CFR 1320.3 and includes [Docket No. FDA–2013–D–1543] solely responsible for ensuring that your
Agency requests or requirements that comment does not include any
members of the public submit reports, Nonproprietary Naming of Biological confidential information that you or a
keep records, or provide information to Products; Guidance for Industry; third party may not wish to be posted,
a third party. Section 3506(c)(2)(A) of Availability such as medical information, your or
the PRA (44 U.S.C. 3506(c)(2)(A)) AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
requires Federal Agencies to provide a HHS. confidential business information, such
60-day notice in the Federal Register ACTION: Notice of availability. as a manufacturing process. Please note
concerning each proposed collection of that if you include your name, contact
information before submitting the SUMMARY: The Food and Drug information, or other information that
collection to OMB for approval. To Administration (FDA or Agency) is identifies you in the body of your
comply with this requirement, in the announcing the availability of a comments, that information will be
Federal Register of February 19, 2015, guidance for industry entitled posted on https://www.regulations.gov.
we gave interested persons 60 days to ‘‘Nonproprietary Naming of Biological • If you want to submit a comment
comment on the information collection Products.’’ The guidance describes our with confidential information that you
provisions in the draft guidance (80 FR current thinking on the need for do not wish to be made available to the
8884 at 8885). biological products previously and public, submit the comment as a
After publishing the 60-day notice newly licensed under the Public Health written/paper submission and in the
requesting public comment, section Service Act (PHS Act) to bear manner detailed (see ‘‘Written/Paper
3507 of the PRA (44 U.S.C. 3507) nonproprietary names that include Submissions’’ and ‘‘Instructions’’).
requires Federal Agencies to submit the FDA-designated suffixes. Accordingly,
we intend to designate nonproprietary Written/Paper Submissions
proposed collection to OMB for review
and clearance. In compliance with 44 names for originator biological products, Submit written/paper submissions as
U.S.C. 3507, we will be submitting a related biological products, or follows:
proposed collection of information to biosimilar products which will include • Mail/Hand delivery/Courier (for
OMB for review and clearance. FDA is a core name and a distinguishing suffix written/paper submissions): Division of
issuing this guidance as final with that is devoid of meaning and composed Dockets Management (HFA–305), Food
portions of it subject to OMB approval of four lowercase letters. This guidance and Drug Administration, 5630 Fishers
of the collection of information and finalizes the draft guidance issued on Lane, Rm. 1061, Rockville, MD 20852.
shaded gray. Those provisions that are August 28, 2015. • For written/paper comments
shaded gray and subject to OMB FDA is also announcing that a submitted to the Division of Dockets
approval will be final if the collection proposed collection of information has Management, FDA will post your
of information is approved. If the been submitted to the Office of comment, as well as any attachments,
collection is approved, FDA will Management and Budget (OMB) for except for information submitted,
publish a notice in the Federal Register review and clearance under the marked and identified, as confidential,
concerning OMB approval and Paperwork Reduction Act of 1995. if submitted as detailed in
providing an OMB control number for DATES: Submit either electronic or ‘‘Instructions.’’
these provisions. written comments on Agency guidances Instructions: All submissions received
The guidance also references at any time. Submit written comments must include the Docket No. FDA–
registration and adverse event reporting on the collection of information by 2013–D–1543 for ‘‘Nonproprietary
for outsourcing facilities. The February 13, 2017. Naming of Biological Products.’’
collections of information for ADDRESSES: To ensure that comments on Received comments will be placed in
outsourcing facility registration have the information collection are received, the docket and, except for those
been approved by OMB under OMB OMB recommends that written submitted as ‘‘Confidential
control number 0910–0777. The comments be faxed to the Office of Submissions,’’ publicly viewable at
collections of information for adverse Information and Regulatory Affairs, https://www.regulations.gov or at the
event reporting by outsourcing facilities OMB, Attn: FDA Desk Officer, FAX: Division of Dockets Management
have been approved by OMB under 202–395–7285, or emailed to oira_ between 9 a.m. and 4 p.m., Monday
submission@omb.eop.gov. All through Friday.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
OMB control number 0910–0800.
comments should be identified with the • Confidential Submissions—To
III. Electronic Access submit a comment with confidential
OMB control number 0910—New and
Persons with access to the Internet title ‘‘Nonproprietary Naming of information that you do not wish to be
can obtain the document at either http:// Biological Products.’’ Also include the made publicly available, submit your
www.fda.gov/Drugs/Guidance FDA docket number found in brackets comments only as a written/paper
ComplianceRegulatoryInformation/ in the heading of this document. submission. You should submit two
Guidances/default.htm or http:// You may submit comments as copies total. One copy will include the
www.regulations.gov. follows: information you claim to be confidential
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Document Created: 2017-01-13 02:45:01
Document Modified: 2017-01-13 02:45:01
| 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 Agency guidances at any time. | |
| 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 | 82 FR 4343 |
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