80 FR 8881 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 33 (February 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 33 (February 19, 2015)
| Page Range | 8881-8884 | |
| FR Document | 2015-03418 |
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)] [Notices] [Pages 8881-8884] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03418] ----------------------------------------------------------------------- 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Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry; Availability ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This draft guidance describes the conditions under which FDA does not intend to take action against a state-licensed pharmacy, a Federal facility, or outsourcing facility that mixes, dilutes, or repackages certain biological products without obtaining an approved biologics license application (BLA). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 20, 2015. ADDRESSES: 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 guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Leah Christl, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20903, 301-796- 0869; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 [[Page 8882]] 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 draft guidance for industry entitled ``Mixing, Diluting, or Repackaging of Biological Products Outside the Scope of an Approved Biologics License Application.'' Certain licensed biological products may need to 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 draft 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 Federal Food, Drug, and Cosmetic Act (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 (21 U.S.C. 262). This draft 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) 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 without obtaining an approved BLA. Elsewhere in this issue of the Federal Register, the Agency is making available for comment a draft guidance entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' When these two guidances become final, they will address and clarify the Agency's policy regarding hospital pharmacies repackaging and safely transferring repackaged drug, including biological products, to other hospitals within the same health system during a drug shortage. Therefore, under section 506F(d) of the FD&C Act (21 U.S.C. 356f(d), when FDA issues these as final guidances, section 506F will no longer apply. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance, when finalized, will represent FDA's current thinking on mixing, diluting, and repackaging of biological products not within the scope of the product's approved BLA as described in the approved labeling for the product. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting and recordkeeping burdens. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. We invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Mixing, Diluting, or Repackaging of Biological Products Outside the Scope of an Approved Biologics License Application. Description: The draft guidance describes FDA's policy with respect to the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the PHS Act when such activities are not within the scope of the product's approved BLA as described in the approved labeling for the product. The draft 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) and where specified, section 501(a)(2)(B) of the FD&C Act, when a state-licensed pharmacy, a Federal facility, or an outsourcing facility mixes, dilutes, or repackages certain biological products without obtaining an approved BLA. The draft guidance includes the following collection of information under the PRA. One condition described in the draft guidance is that, if the biological product is mixed, diluted, or repackaged by an outsourcing facility, the label on the immediate container (primary packaging, e.g., the syringe) of the mixed, diluted, or repackaged product includes the following information:The statement ``This product was mixed or diluted by [name of outsourcing facility],'' or ``This product was repackaged by [name of outsourcing facility]'' whichever statement is appropriate; the address and phone number of the outsourcing facility that mixed, diluted, or repackaged the biological product; the proper name of the original biological product that was mixed, diluted, or repackaged; the lot or batch number of the mixed, diluted, or repackaged biological product; the dosage form and strength; a statement of either the quantity or the volume of the mixed, diluted, or repackaged biological product, whichever is appropriate; the date the biological product was mixed, diluted, or repackaged; the beyond-use-date (BUD) of the mixed, diluted, or repackaged biological product; storage and handling instructions for the mixed, diluted, or repackaged biological product; the National Drug Code (NDC) number of the mixed, diluted, or [[Page 8883]] repackaged biological product, if available; \1\ --------------------------------------------------------------------------- \1\ The NDC number of the original licensed biological product should not be placed on the mixed, diluted, or repackaged biological product. --------------------------------------------------------------------------- The statement ``Not for resale,'' and, if the biological product is distributed by an outsourcing facility other than pursuant to a prescription for an individual identified patient, the statement ``Office Use Only''; and If included on the label of the FDA-licensed product from which the biological product is being mixed, diluted, or repackaged, a list of the active and inactive ingredients; and if the ingredients are listed because they were listed on the original product, the label of the mixed, diluted, or repackaged product should include any additional ingredients that appear in the mixed, diluted, or repackaged product. Another condition in the draft guidance is that, if the immediate product label is too small or the mixed, diluted, or repackaged product is otherwise unable to accommodate a label with sufficient space to bear the active and inactive ingredients, such information should be included on the label of the container from which the individual units are removed for administration (secondary packaging, e.g., the bag, box, or other package in which the mixed, diluted, or repackaged biological products are distributed). In addition, the draft guidance describes the conditions that the container label include directions for use, including, as appropriate, dosage and administration, and the following information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA- 1088. Another condition in the draft guidance is that each mixed, diluted, or repackaged biological product is also accompanied by a copy of the prescribing information that accompanied the original licensed biological product that was mixed, diluted, or repackaged. We estimate that annually a total of approximately five registered outsourcing facilities that mix, dilute, or repackage biological products (``Number of Respondents'' in table 1, row 1) will each design, test, and produce approximately five different labels (``Frequency per Disclosure'' in table 1, row 1), for a total of 25 labels that include the information set forth in section III.B of the draft guidance (including directions for use) (``Total Disclosures'' in table 1, row 1). We also estimate that designing, testing, and producing each label will take approximately 0.5 hours (``Hours per Disclosure'' in table 1, row 1). The provision to add http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden estimate because it is not considered a collection of information under the PRA because the information is ``originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)). Section III.C of the draft guidance discusses the preparation of prescription sets (i.e., licensed allergenic extracts that are combined to provide subcutaneous immunotherapy to an individual patient) by a physician, state-licensed pharmacy, a Federal facility, or outsourcing facility. Under the draft guidance, if the prescription set is mixed or diluted by an outsourcing facility, the label on the immediate container of the prescription set (primary packaging) includes: The patient's name as identified on the prescription; the statement ``This prescription set was prepared by [name of outsourcing facility]''; the address and phone number of the outsourcing facility that prepared the prescription set; the identity of each allergenic extract in the prescription set and the quantity of each; the dilution of each dilution vial; the lot or batch number of the prescription set; the date the prescription set was prepared; the BUD of the prescription set; storage and handling instructions for the prescription set; and the statement ``Not for resale''. In addition, under the draft guidance, the label of the container from which the individual units of the prescription set are removed for administration (secondary packaging) includes the following information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088. Each prescription set prepared is also accompanied by instructions for use and the FDA approved package insert for each allergenic extract. We estimate that annually a total of approximately five outsourcing facilities that prepare prescription sets (``Number of Respondents'' in table 2, row 1) will each include the information set forth in section III.C of the draft guidance (including directions for use) on the labels, packages, and/or containers of approximately 300 prescription sets (``Frequency per Disclosure'' in table 2, row 1) for a total of 1500 disclosures (``Total Disclosures'' in table 2, row 1). We also estimate that the initial process of designing, testing, and producing, and attaching each label, package, and/or container to each prescription set will take approximately 0.5 hours (``Hours per Disclosure'' in table 2, row 1). The provision to add the statement http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden estimate because it is not considered a collection of information under the PRA because the information is ``originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)). We also estimate that a total of approximately five outsourcing facilities (``Number of Respondents'' in table 2, row 2) will each design, test, and produce the instructions for use and a copy of prescribing information, as set forth in section III.C of the draft guidance, for approximately 300 prescription sets (``Frequency per Disclosure'' in table 2, row 2) for a total of 1500 disclosures (total disclosures'' in table 2, row 2), which we estimate will take approximately 1 hour for each prescription set (``Hours per Disclosure'' in table 2, row 2). The provision to include http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden estimate because they are not considered a collection of information under the PRA because the information is ``originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)). The total estimated third-party disclosure burden resulting from the draft guidance is as follows: [[Page 8884]] Table 1--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Biological product mixing, Number of Frequency per Total Hours per diluting, and repackaging respondents disclosure disclosures disclosure Total hours ---------------------------------------------------------------------------------------------------------------- Designing, testing, and 5 5 25 0.5 12.5 producing the label, container, packages, and/or outer containers for each mixed, diluted, or repackaged biological product............ Prescribing information 5 5 25 1 25 labeling accompanying each mixed, diluted, or repackaged drug product.................. -------------------------------------------------------------------------------- Total...................... .............. .............. .............. .............. 37.5 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. *(30 minutes) Table 2--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Preparation of prescription Number of Frequency per Total Hours per sets respondents disclosure disclosures disclosure Total hours ---------------------------------------------------------------------------------------------------------------- Designing, testing, and 5 300 1500 0.5 750 producing each label on immediate containers, packages, and/or outer containers.................... Including instructions for use 5 300 1500 1 1500 labeling and the original package insert(s) for each prescription set.............. -------------------------------------------------------------------------------- Total...................... .............. .............. .............. .............. 2250 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. *(30 minutes) The draft guidance also references registration, product reporting, current good manufacturing practice (CGMP) requirements, and the payment of certain fees by human drug compounding outsourcing facilities. In the Federal Register of December 4, 2013 (78 FR 72899), FDA estimated the burden resulting from outsourcing facility registration. In the Federal Register of December 4, 2013 (78 FR 72897), FDA estimated the burden resulting from outsourcing facility interim product reporting. In the Federal Register of April 1, 2014 (79 FR 18297), FDA estimated the burden resulting from the payment of certain fees by outsourcing facilities. In the Federal Register of July 2, 2014 (79 FR 37743), FDA estimated the burden resulting from outsourcing facility compliance with CGMP requirements. IV. Electronic Access Persons with access to the Internet can obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Dated: February 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03418 Filed 2-18-15; 8:45 am] BILLING CODE 4164-01-P
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average bur-
Number of
Number of Total annual den per rec-
Compounding MOU between FDA and States records per Total Hours
recordkeepers records ordkeeping
recordkeeper (in Hours)
State recordkeeping for 3 years of compounding com-
plaints ............................................................................. 25 15 375 1 375
Total ............................................................................ 25 15 375 1 375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average bur-
Number of disclosures Total annual den per disclo-
Compounding MOU between FDA and States Total hours
respondents per disclosures sure
respondent (in Hours)
State notification to pharmacists, pharmacies, and physi-
cians that its participation in the MOU has been termi-
nated by FDA ................................................................... 1 1 1 1 1
Total .............................................................................. 1 1 1 1 1
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
VII. Request for Comments VIII. Electronic Access DATES: Although you can comment on
Persons with access to the Internet any guidance at any time (see 21 CFR
FDA invites comments from 10.115(g)(5)), to ensure that the Agency
interested persons on the new draft may obtain the draft standard MOU at
http://www.regulations.gov. considers your comment on this draft
standard MOU that would establish an guidance before it begins work on the
agreement between the signatory States Dated: February 12, 2015. final version of the guidance, submit
and FDA regarding the appropriate Leslie Kux, either electronic or written comments
investigation by such States of Associate Commissioner for Policy. on the draft guidance by May 20, 2015.
complaints relating to compounded [FR Doc. 2015–03420 Filed 2–18–15; 8:45 am] ADDRESSES: Submit written requests for
human drug products distributed BILLING CODE 4164–01–P single copies of this guidance to the
outside the State, and the distribution of Division of Drug Information, Center for
inordinate amounts of compounded Drug Evaluation and Research, Food
human drug products interstate. The DEPARTMENT OF HEALTH AND and Drug Administration, 10903 New
Agency is providing a 120-day comment HUMAN SERVICES Hampshire Ave., Bldg. 51, Rm. 2201,
period. Silver Spring, MD 20993–0002; or the
Food and Drug Administration Office of Communication, Outreach and
After considering any comments on
Development, Center for Biologics
the new draft standard MOU submitted [Docket No. FDA–2014–D–1525] Evaluation and Research (CBER), Food
to this docket, FDA intends to finalize
and Drug Administration, 10903 New
the standard MOU and make it available Mixing, Diluting, or Repackaging
Hampshire Avenue, Bldg. 71, Rm. 3128,
for signature by individual States. FDA Biological Products Outside the Scope
Silver Spring, MD 20993–0002. Send
will determine at the time of publication of an Approved Biologics License
one self-addressed adhesive label to
of the final MOU how long it will allow Application; Draft Guidance for
assist that office in processing your
States to consider whether to sign the Industry; Availability
requests. See the SUPPLEMENTARY
MOU before FDA begins to enforce the INFORMATION section for electronic
ACTION: Notice.
5 percent limit in those States that have access to the guidance document.
not signed an MOU. SUMMARY: The Food and Drug Submit electronic comments on the
Interested persons may submit either Administration (FDA or the Agency) is guidance to http://www.regulations.gov.
electronic comments regarding this announcing the availability of a draft Submit written comments to the
document to http://www.regulations.gov guidance for industry entitled ‘‘Mixing, Division of Dockets Management (HFA–
or written comments to the Division of Diluting, or Repackaging Biological 305), Food and Drug Administration,
Dockets Management (see ADDRESSES). It Products Outside the Scope of an 5630 Fishers Lane, Rm. 1061, Rockville,
is only necessary to send one set Approved Biologics License MD 20852.
comments. Identify comments with the Application.’’ This draft guidance FOR FURTHER INFORMATION CONTACT:
emcdonald on DSK67QTVN1PROD with NOTICES
docket number found in brackets in the describes the conditions under which Leah Christl, Center for Drugs
heading of this document. Received FDA does not intend to take action Evaluation and Research, Food and
against a state-licensed pharmacy, a Drug Administration, 10903 New
comments may be seen in the Division
Federal facility, or outsourcing facility Hampshire Ave., Bldg. 22, Rm. 6426,
of Dockets Management between 9 a.m.
that mixes, dilutes, or repackages Silver Spring, MD 20903, 301–796–
and 4 p.m., Monday through Friday, and
certain biological products without 0869; or Stephen Ripley, Center for
will be posted to the docket at http:// obtaining an approved biologics license Biologics Evaluation and Research,
www.regulations.gov. application (BLA). Food and Drug Administration, 10903
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New Hampshire Ave., Bldg. 71, Rm. guidances, section 506F will no longer Title: Draft Guidance for Industry:
7301, Silver Spring, MD 20993–0002, apply. Mixing, Diluting, or Repackaging of
240–402–7911. This draft guidance is being issued Biological Products Outside the Scope
SUPPLEMENTARY INFORMATION: consistent with FDA’s good guidance of an Approved Biologics License
practices regulation (21 CFR 10.115). Application.
I. Background This guidance, when finalized, will Description: The draft guidance
FDA is announcing the availability of represent FDA’s current thinking on describes FDA’s policy with respect to
a draft guidance for industry entitled mixing, diluting, and repackaging of the mixing, diluting, and repackaging of
‘‘Mixing, Diluting, or Repackaging of biological products not within the scope certain types of biological products that
Biological Products Outside the Scope of the product’s approved BLA as have been licensed under section 351 of
of an Approved Biologics License described in the approved labeling for the PHS Act when such activities are
Application.’’ Certain licensed the product. It does not create or confer not within the scope of the product’s
biological products may need to be any rights for or on any person and does approved BLA as described in the
mixed, diluted, or repackaged in a way not operate to bind FDA or the public. approved labeling for the product. The
not described in the approved labeling An alternative approach may be used if draft guidance describes the conditions
for the product to meet the needs of a such approach satisfies the under which FDA does not intend to
specific patient. For example, for some requirements of the applicable statutes take action for violations of section 351
biological products there is no licensed and regulations. of the PHS Act and section 502(f)(1) and
pediatric strength and/or dosage form. where specified, section 501(a)(2)(B) of
II. Comments
In addition, there may be certain the FD&C Act, when a state-licensed
circumstances when a person would Interested persons may submit either
electronic comments regarding this pharmacy, a Federal facility, or an
remove a licensed biological product outsourcing facility mixes, dilutes, or
from its original container and place it document to http://www.regulations.gov
or written comments to the Division of repackages certain biological products
into a different container(s) (repackage without obtaining an approved BLA.
it), in a manner that is not within the Dockets Management (see ADDRESSES). It
scope of the approved labeling for the is only necessary to send one set of The draft guidance includes the
product. As described in the draft comments. Identify comments with the following collection of information
guidance, mixed, diluted, or repackaged docket number found in brackets in the under the PRA.
biological products are not eligible for heading of this document. Received One condition described in the draft
the statutory exemptions available to comments may be seen in the Division guidance is that, if the biological
certain compounded drugs under of Dockets Management between 9 a.m. product is mixed, diluted, or repackaged
sections 503A and 503B of the Federal and 4 p.m., Monday through Friday, and by an outsourcing facility, the label on
Food, Drug, and Cosmetic Act (FD&C will be posted to the docket at http:// the immediate container (primary
Act) (21 U.S.C. 353A and 353B). In www.regulations.gov. packaging, e.g., the syringe) of the
addition, a biological product that is mixed, diluted, or repackaged product
III. Paperwork Reduction Act of 1995
mixed, diluted, or repackaged outside includes the following information:
the scope of an approved BLA is This draft guidance contains • The statement ‘‘This product was
considered an unlicensed biological information collection provisions that mixed or diluted by [name of
product under section 351 of the Public are subject to review by OMB under the outsourcing facility],’’ or ‘‘This product
Health Service (PHS) Act (21 U.S.C. Paperwork Reduction Act of 1995 (44 was repackaged by [name of outsourcing
262). U.S.C. 3501–3520). The title, facility]’’ whichever statement is
This draft guidance describes the description, and respondent description appropriate;
conditions under which FDA does not of the information collection are given
• the address and phone number of
intend to take action for violations of under this section with an estimate of
the outsourcing facility that mixed,
section 351 of the PHS Act and section the annual reporting and recordkeeping
diluted, or repackaged the biological
502(f)(1) (21 U.S.C. 352(f)(1) and where burdens. Included in the estimate is the
product;
specified, section 501(a)(2)(B) (21 U.S.C. time for reviewing instructions,
searching existing data sources, • the proper name of the original
351(a)(2)(B) of the FD&C Act, when a
gathering and maintaining the data biological product that was mixed,
state-licensed pharmacy, a Federal
needed, and completing and reviewing diluted, or repackaged;
facility, or an outsourcing facility
dilutes, mixes, or repackages certain the collection of information. • the lot or batch number of the
biological products without obtaining We invite comments on these topics: mixed, diluted, or repackaged biological
an approved BLA. (1) Whether the proposed collection of product;
Elsewhere in this issue of the Federal information is necessary for the proper • the dosage form and strength;
Register, the Agency is making available performance of FDA’s functions, • a statement of either the quantity or
for comment a draft guidance entitled including whether the information will the volume of the mixed, diluted, or
‘‘Repackaging of Certain Human Drug have practical utility; (2) the accuracy of repackaged biological product,
Products by Pharmacies and FDA’s estimate of the burden of the whichever is appropriate;
Outsourcing Facilities.’’ When these two proposed collection of information, • the date the biological product was
guidances become final, they will including the validity of the mixed, diluted, or repackaged;
address and clarify the Agency’s policy methodology and assumptions used; (3)
• the beyond-use-date (BUD) of the
emcdonald on DSK67QTVN1PROD with NOTICES
regarding hospital pharmacies ways to enhance the quality, utility, and
mixed, diluted, or repackaged biological
repackaging and safely transferring clarity of the information to be
product;
repackaged drug, including biological collected; and (4) ways to minimize the
products, to other hospitals within the burden of the collection of information • storage and handling instructions
same health system during a drug on respondents, including through the for the mixed, diluted, or repackaged
shortage. Therefore, under section use of automated collection techniques, biological product;
506F(d) of the FD&C Act (21 U.S.C. when appropriate, and other forms of • the National Drug Code (NDC)
356f(d), when FDA issues these as final information technology. number of the mixed, diluted, or
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repackaged biological product, if row 1), for a total of 25 labels that prepared is also accompanied by
available; 1 include the information set forth in instructions for use and the FDA
• The statement ‘‘Not for resale,’’ and, section III.B of the draft guidance approved package insert for each
if the biological product is distributed (including directions for use) (‘‘Total allergenic extract.
by an outsourcing facility other than Disclosures’’ in table 1, row 1). We also We estimate that annually a total of
pursuant to a prescription for an estimate that designing, testing, and approximately five outsourcing facilities
individual identified patient, the producing each label will take that prepare prescription sets (‘‘Number
statement ‘‘Office Use Only’’; and approximately 0.5 hours (‘‘Hours per of Respondents’’ in table 2, row 1) will
• If included on the label of the FDA- Disclosure’’ in table 1, row 1). The each include the information set forth in
licensed product from which the provision to add http://www.fda.gov/ section III.C of the draft guidance
biological product is being mixed, medwatch and 1–800–FDA–1088 is not (including directions for use) on the
diluted, or repackaged, a list of the included in this burden estimate labels, packages, and/or containers of
active and inactive ingredients; and if because it is not considered a collection approximately 300 prescription sets
the ingredients are listed because they of information under the PRA because (‘‘Frequency per Disclosure’’ in table 2,
were listed on the original product, the the information is ‘‘originally supplied row 1) for a total of 1500 disclosures
label of the mixed, diluted, or by the Federal Government to the (‘‘Total Disclosures’’ in table 2, row 1).
repackaged product should include any recipient for the purpose of disclosure We also estimate that the initial process
additional ingredients that appear in the to the public’’ (5 CFR 1320.3(c)(2)). of designing, testing, and producing,
mixed, diluted, or repackaged product. Section III.C of the draft guidance
Another condition in the draft and attaching each label, package, and/
discusses the preparation of or container to each prescription set will
guidance is that, if the immediate prescription sets (i.e., licensed
product label is too small or the mixed, take approximately 0.5 hours (‘‘Hours
allergenic extracts that are combined to per Disclosure’’ in table 2, row 1). The
diluted, or repackaged product is provide subcutaneous immunotherapy
otherwise unable to accommodate a provision to add the statement http://
to an individual patient) by a physician, www.fda.gov/medwatch and 1–800–
label with sufficient space to bear the state-licensed pharmacy, a Federal
active and inactive ingredients, such FDA–1088 is not included in this
facility, or outsourcing facility. Under burden estimate because it is not
information should be included on the the draft guidance, if the prescription
label of the container from which the considered a collection of information
set is mixed or diluted by an under the PRA because the information
individual units are removed for
outsourcing facility, the label on the is ‘‘originally supplied by the Federal
administration (secondary packaging,
immediate container of the prescription Government to the recipient for the
e.g., the bag, box, or other package in
set (primary packaging) includes: purpose of disclosure to the public’’ (5
which the mixed, diluted, or repackaged
• The patient’s name as identified on CFR 1320.3(c)(2)).
biological products are distributed).
In addition, the draft guidance the prescription;
We also estimate that a total of
describes the conditions that the • the statement ‘‘This prescription set
approximately five outsourcing facilities
container label include directions for was prepared by [name of outsourcing
(‘‘Number of Respondents’’ in table 2,
use, including, as appropriate, dosage facility]’’;
row 2) will each design, test, and
and administration, and the following • the address and phone number of
produce the instructions for use and a
information to facilitate adverse event the outsourcing facility that prepared
copy of prescribing information, as set
reporting: http://www.fda.gov/ the prescription set;
forth in section III.C of the draft
• the identity of each allergenic
medwatch and 1–800–FDA–1088. guidance, for approximately 300
extract in the prescription set and the
Another condition in the draft guidance prescription sets (‘‘Frequency per
quantity of each;
is that each mixed, diluted, or Disclosure’’ in table 2, row 2) for a total
• the dilution of each dilution vial;
repackaged biological product is also of 1500 disclosures (total disclosures’’
• the lot or batch number of the
accompanied by a copy of the in table 2, row 2), which we estimate
prescription set;
prescribing information that will take approximately 1 hour for each
• the date the prescription set was
accompanied the original licensed prescription set (‘‘Hours per Disclosure’’
prepared;
biological product that was mixed, in table 2, row 2). The provision to
• the BUD of the prescription set;
diluted, or repackaged. include http://www.fda.gov/medwatch
We estimate that annually a total of • storage and handling instructions
for the prescription set; and and 1–800–FDA–1088 is not included in
approximately five registered this burden estimate because they are
outsourcing facilities that mix, dilute, or • the statement ‘‘Not for resale’’.
In addition, under the draft guidance, not considered a collection of
repackage biological products (‘‘Number information under the PRA because the
the label of the container from which
of Respondents’’ in table 1, row 1) will information is ‘‘originally supplied by
the individual units of the prescription
each design, test, and produce the Federal Government to the recipient
set are removed for administration
approximately five different labels for the purpose of disclosure to the
(secondary packaging) includes the
(‘‘Frequency per Disclosure’’ in table 1, public’’ (5 CFR 1320.3(c)(2)).
following information to facilitate
1 The NDC number of the original licensed adverse event reporting: http:// The total estimated third-party
biological product should not be placed on the www.fda.gov/medwatch and 1–800– disclosure burden resulting from the
mixed, diluted, or repackaged biological product. FDA–1088. Each prescription set draft guidance is as follows:
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![8884 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Frequency per Total Hours per
Biological product mixing, diluting, and repackaging Total hours
respondents disclosure disclosures disclosure
Designing, testing, and producing the label, container,
packages, and/or outer containers for each mixed, di-
luted, or repackaged biological product ......................... 5 5 25 0.5 12.5
Prescribing information labeling accompanying each
mixed, diluted, or repackaged drug product .................. 5 5 25 1 25
Total ............................................................................ ........................ ........................ ........................ ........................ 37.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Frequency per Total Hours per
Preparation of prescription sets Total hours
respondents disclosure disclosures disclosure
Designing, testing, and producing each label on imme-
diate containers, packages, and/or outer containers ..... 5 300 1500 0.5 750
Including instructions for use labeling and the original
package insert(s) for each prescription set .................... 5 300 1500 1 1500
Total ............................................................................ ........................ ........................ ........................ ........................ 2250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)
The draft guidance also references DEPARTMENT OF HEALTH AND CPG Manual, entitled ‘‘Hospital
registration, product reporting, current HUMAN SERVICES Pharmacies—Status as Drug
good manufacturing practice (CGMP) Manufacturer,’’ which was issued in
requirements, and the payment of Food and Drug Administration October 1980.
certain fees by human drug [Docket No. FDA–2014–D–1524] DATES: Although you can comment on
compounding outsourcing facilities. In any guidance at any time (see 21 CFR
the Federal Register of December 4, Repackaging of Certain Human Drug 10.115(g)(5)), to ensure that the Agency
2013 (78 FR 72899), FDA estimated the Products by Pharmacies and considers your comment on this draft
burden resulting from outsourcing Outsourcing Facilities; Draft Guidance guidance before it begins work on the
facility registration. In the Federal for Industry; Availability final version of the guidance, submit
Register of December 4, 2013 (78 FR either electronic or written comments
AGENCY: Food and Drug Administration,
72897), FDA estimated the burden on the draft guidance by May 20, 2015.
HHS.
resulting from outsourcing facility ADDRESSES: Submit written requests for
ACTION: Notice of availability.
interim product reporting. In the single copies of this guidance to the
Federal Register of April 1, 2014 (79 FR SUMMARY: The Food and Drug Division of Drug Information, Center for
18297), FDA estimated the burden Administration (FDA or the Agency) is Drug Evaluation and Research, Food
resulting from the payment of certain announcing the availability of a draft and Drug Administration, 10903 New
fees by outsourcing facilities. In the guidance for industry entitled Hampshire Ave., Bldg. 51, Rm. 2201,
Federal Register of July 2, 2014 (79 FR ‘‘Repackaging of Certain Human Drug Silver Spring, MD 20993–0002. Send
37743), FDA estimated the burden Products by Pharmacies and one self-addressed adhesive label to
resulting from outsourcing facility Outsourcing Facilities.’’ This guidance assist that office in processing your
compliance with CGMP requirements. describes the conditions under which requests. See the SUPPLEMENTARY
FDA does not intend to take action for INFORMATION section for electronic
IV. Electronic Access violations of the Federal Food, Drug, access to the guidance document.
and Cosmetic Act (the FD&C Act), when Submit electronic comments on the
Persons with access to the Internet a state-licensed pharmacy, a Federal guidance to http://www.regulations.gov.
can obtain the document at either facility, or an outsourcing facility Submit written comments to the
http://www.fda.gov/Drugs/Guidance repackages human drug products. Division of Dockets Management (HFA–
ComplianceRegulatoryInformation/ When this guidance becomes final, 305), Food and Drug Administration,
Guidances/default.htm, http:// the Agency may also consider 5630 Fishers Lane, Rm. 1061, Rockville,
www.fda.gov/BiologicsBloodVaccines/ withdrawing or revising other guidance MD 20852.
GuidanceComplianceRegulatory documents that address human drug FOR FURTHER INFORMATION CONTACT: Gail
emcdonald on DSK67QTVN1PROD with NOTICES
Information/default.htm or http:// repackaging, including section 446.100 Bormel, Food and Drug Administration,
www.regulations.gov. of the Compliance Program Guidance 10001 New Hampshire Ave., Silver
Dated: February 11, 2015. (CPG) Manual, entitled ‘‘Regulatory Spring, MD 20903, 301–796–3110.
Action Regarding Approved New Drugs SUPPLEMENTARY INFORMATION:
Leslie Kux,
and Antibiotic Drug Products Subjected
Associate Commissioner for Policy. to Additional Processing or other I. Announcement of Draft Guidance
[FR Doc. 2015–03418 Filed 2–18–15; 8:45 am] Manipulations,’’ which was issued in FDA is announcing the availability of
BILLING CODE 4164–01–P January 1991, and section 460.100 of the a draft guidance for industry entitled
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Document Created: 2018-02-16 11:12:18
Document Modified: 2018-02-16 11:12:18
| 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. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 20, 2015. | |
| Contact | Leah Christl, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20903, 301-796- 0869; 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 | 80 FR 8881 |
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