81 FR 96011 - Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96011-96013 | |
| FR Document | 2016-31513 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96011-96013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31513] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-4318] Compounding and Repackaging of Radiopharmaceuticals by State- Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 27, 2017. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by February 27, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-2016-D-4318 for ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.'' Received [[Page 96012]] 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 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 https://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 https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Edisa Gozun, 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 Under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities, and radiopharmaceuticals that are repackaged, are subject to all applicable provisions of the FD&C Act related to the production of drugs. Because Congress explicitly excluded radiopharmaceuticals from section 503A of the FD&C Act (21 U.S.C. 353a) (see section 503A(d)(2)),\1\ compounded radiopharmaceuticals are not eligible for the exemptions under section 503A from section 505 of the FD&C Act (21 U.S.C. 355) (concerning new drug approval requirements), section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning labeling with adequate directions for use), and section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)B)) (concerning current good manufacturing practice (CGMP) requirements). In addition, Congress did not exempt repackaged radiopharmaceuticals from any provisions of the FD&C Act. --------------------------------------------------------------------------- \1\ Section 503A of the FD&C Act describes the conditions that must be met for drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to qualify for exemptions from sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act states that ``this section shall not apply to . . . radiopharmaceuticals.'' --------------------------------------------------------------------------- Because State-licensed nuclear pharmacies and Federal facilities sometimes compound or repackage radiopharmaceuticals for patients, but radiopharmaceuticals are not eligible for the exemptions in section 503A of the FD&C Act, FDA is issuing this guidance to describe the conditions under which the Agency does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a State-licensed nuclear pharmacy or a Federal facility that is not an outsourcing facility compounds or repackages radiopharmaceuticals for human use. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a separate draft guidance document concerning compounding and repackaging of radiopharmaceuticals by outsourcing facilities entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal 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. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 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, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this document, FDA invites comments on the following 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. One of the conditions of the draft guidance is that the compounded radiopharmaceutical is not essentially a copy of an approved radiopharmaceutical. If a compounder intends to rely on a determination from a prescriber that there is a change between the compounded radiopharmaceutical and the [[Page 96013]] comparable approved radiopharmaceutical that produces for an identified individual patient a clinical difference, the determination is documented on the prescription or order in writing by either (1) the prescribing practitioner, or (2) the compounder, reflecting a conversation with the prescribing practitioner. The compounder maintains records of the prescription or order documenting this determination. We estimate that annually a total of approximately 10 compounders (``No. of Respondents'' in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded radiopharmaceutical has a change that produces a clinical difference for an identified individual patient as compared to the comparable approved radiopharmaceutical. We estimate that compounders will document this determination on approximately 250 prescriptions or orders for compounded radiopharmaceuticals ``Total Annual Disclosures'' in table 1, line 1). We estimate that the consultation between the compounder and the prescriber and noting this determination on each prescription or order that does not already document this determination will take approximately 3 minutes per prescription or order. A compounder also maintains records of prescriptions or orders noting the determination that a prescriber has determined that the compounded radiopharmaceutical has a change that produces a clinical difference for an identified individual patient. We estimate that the compounder will take approximately 2.1 hours to maintain the records of 250 prescriptions or orders documenting the prescriber's determination of clinical difference (``Total Hours'' in table 2). We estimate that maintaining such records will take approximately 30 seconds per prescription or order. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of disclosures per Total annual Average burden per disclosure Total hours respondents respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- Consultation between the compounder and 10 25 250 3 minutes.......................... 12.5 prescriber or health care facility, and the notation on the prescription or order documenting the prescriber's determination of clinical difference. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Maintenance of records of prescriptions or 10 25 250 30 seconds......................... 2.1 orders documenting the prescriber's determination of clinical difference. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31513 Filed 12-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96011
Clinical pharmacology studies are the Paperwork Reduction Act of 1995 DATES: Although you can comment on
part of a stepwise approach for (44 U.S.C. 3501–3520). The collection of any guidance at any time (see 21 CFR
developing the data and information information submitted under section 10.115(g)(5)), to ensure that the Agency
needed to support a demonstration of 351(k) applications for biosimilars is considers your comment on this draft
biosimilarity. These studies can reduce approved under OMB control number guidance before it begins work on the
the residual uncertainty in assessing the 0910–0719. The collection of final version of the guidance, submit
biosimilarity between a proposed information submitted under 21 CFR either electronic or written comments
biosimilar product and reference part 312 is approved under OMB control on the draft guidance by February 27,
product and inform the design of number 0910–0014. 2017. Submit either electronic or
subsequent clinical trials to assess written comments concerning the
III. Electronic Access collection of information proposed in
clinically meaningful differences. This
guidance is intended to assist sponsors Persons with access to the Internet the draft guidance by February 27, 2017.
in designing such studies in support of may obtain the guidance at either http:// ADDRESSES: You may submit comments
applications submitted under section www.fda.gov/Drugs/Guidance as follows:
351(k) of the Public Health Service Act ComplianceRegulatoryInformation/
Guidances/default.htm, http:// Electronic Submissions
(42 U.S.C. 262(k)), as added by the BPCI
Act.1 In particular, this guidance www.fda.gov/BiologicsBloodVaccines/ Submit electronic comments in the
discusses certain critical considerations GuidanceComplianceRegulatory following way:
for using clinical pharmacology testing Information/default.htm, or http:// • Federal eRulemaking Portal:
to support biosimilarity, approaches for www.regulations.gov. https://www.regulations.gov. Follow the
developing the appropriate clinical instructions for submitting comments.
Dated: December 22, 2016.
pharmacology database to support a Comments submitted electronically,
Leslie Kux,
demonstration of biosimilarity, and the including attachments, to https://
Associate Commissioner for Policy. www.regulations.gov will be posted to
utility of modeling and simulation for
[FR Doc. 2016–31511 Filed 12–28–16; 8:45 am] the docket unchanged. Because your
designing and analyzing clinical trials.
Scientific principles described in the BILLING CODE 4164–01–P comment will be made public, you are
guidance may also be informative for solely responsible for ensuring that your
the development of certain biological comment does not include any
DEPARTMENT OF HEALTH AND confidential information that you or a
products under section 505(b)(2) of the HUMAN SERVICES
Federal Food, Drug, and Cosmetic Act third party may not wish to be posted,
(21 U.S.C. 355(b)(2)). such as medical information, your or
Food and Drug Administration
On May 14, 2014, FDA issued a notice anyone else’s Social Security number, or
announcing the availability of a draft [Docket No. FDA–2016–D–4318] confidential business information, such
guidance with the same name as the as a manufacturing process. Please note
current guidance to solicit comments Compounding and Repackaging of that if you include your name, contact
from the public (79 FR 27622). After Radiopharmaceuticals by State- information, or other information that
carefully reviewing received comments Licensed Nuclear Pharmacies and identifies you in the body of your
and in light of increased regulatory Federal Facilities; Draft Guidance for comments, that information will be
experience and the evolution of the Industry; Availability posted on https://www.regulations.gov.
science in biosimilar product • If you want to submit a comment
AGENCY: Food and Drug Administration, with confidential information that you
development and evaluation, FDA has HHS.
finalized that guidance with certain do not wish to be made available to the
changes. These changes are for clarity, ACTION: Notice. public, submit the comment as a
however, and are not substantive. written/paper submission and in the
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
This guidance is one in a series that Administration (FDA or Agency) is
FDA is developing to implement the Submissions’’ and ‘‘Instructions’’).
announcing the availability of a draft
BPCI Act and is being issued consistent guidance for industry entitled Written/Paper Submissions
with FDA’s good guidance practices ‘‘Compounding and Repackaging of
regulation (21 CFR 10.115). The Submit written/paper submissions as
Radiopharmaceuticals by State-Licensed follows:
guidance represents the current thinking Nuclear Pharmacies and Federal • Mail/Hand delivery/Courier (for
of FDA on conducting clinical Facilities.’’ This guidance sets forth written/paper submissions): Division of
pharmacology studies in support of FDA’s policy regarding compounding Dockets Management (HFA–305), Food
proposed biosimilar products. It does and repackaging of and Drug Administration, 5630 Fishers
not establish any rights for any person radiopharmaceuticals for human use by Lane, Rm. 1061, Rockville, MD 20852.
and is not binding on FDA or the public. State-licensed nuclear pharmacies and • For written/paper comments
You can use an alternative approach if Federal facilities that are not registered submitted to the Division of Dockets
it satisfies the requirements of the as outsourcing facilities. Because such Management, FDA will post your
applicable statutes and regulations. radiopharmaceuticals are not eligible for comment, as well as any attachments,
II. The Paperwork Reduction Act of exemptions from provisions of the except for information submitted,
Federal Food, Drug, and Cosmetic Act marked and identified, as confidential,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1995
The guidance refers to previously (the FD&C Act) related to the production if submitted as detailed in
approved collections of information that of drugs, FDA is issuing this guidance ‘‘Instructions.’’
to describe the conditions under which Instructions: All submissions received
are subject to review by the Office of
it does not intend to take action for must include the Docket No. FDA–
Management and Budget (OMB) under
violations of certain provisions of the 2016–D–4318 for ‘‘Compounding and
1 The BPCI Act was enacted as part of the Patient FD&C Act when a State-licensed nuclear Repackaging of Radiopharmaceuticals
Protection and Affordable Care Act (Pub. L. 111– pharmacy or Federal facility compounds by State-Licensed Nuclear Pharmacies
148) on March 23, 2010. or repackages radiopharmaceuticals. and Federal Facilities.’’ Received
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![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96013
comparable approved radiopharmaceutical has a change that A compounder also maintains records
radiopharmaceutical that produces for produces a clinical difference for an of prescriptions or orders noting the
an identified individual patient a identified individual patient as determination that a prescriber has
clinical difference, the determination is compared to the comparable approved determined that the compounded
documented on the prescription or radiopharmaceutical. We estimate that radiopharmaceutical has a change that
order in writing by either (1) the compounders will document this produces a clinical difference for an
prescribing practitioner, or (2) the determination on approximately 250 identified individual patient. We
compounder, reflecting a conversation prescriptions or orders for compounded estimate that the compounder will take
with the prescribing practitioner. The radiopharmaceuticals ‘‘Total Annual approximately 2.1 hours to maintain the
compounder maintains records of the Disclosures’’ in table 1, line 1). We records of 250 prescriptions or orders
prescription or order documenting this estimate that the consultation between documenting the prescriber’s
determination. the compounder and the prescriber and determination of clinical difference
We estimate that annually a total of (‘‘Total Hours’’ in table 2). We estimate
noting this determination on each
approximately 10 compounders (‘‘No. of that maintaining such records will take
prescription or order that does not
Respondents’’ in table 1, line 1) will approximately 30 seconds per
consult a prescriber to determine already document this determination prescription or order.
whether he or she has made a will take approximately 3 minutes per FDA estimates the burden of this
determination that the compounded prescription or order. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of reporting burden per Total hours
respondents per disclosures disclosure
respondent
Consultation between the compounder and prescriber or 10 25 250 3 minutes .... 12.5
health care facility, and the notation on the prescription or
order documenting the prescriber’s determination of clin-
ical difference.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of burden
Number of Total annual
Type of reporting records per per Total hours
recordkeepers records
recordkeeper record-
keeping
Maintenance of records of prescriptions or orders docu- 10 25 250 30 seconds .. 2.1
menting the prescriber’s determination of clinical dif-
ference.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND submission of manufacturing
HUMAN SERVICES establishment information (MEI) under
Persons with access to the Internet the Federal Food, Drug, and Cosmetic
may obtain the draft guidance at either Food and Drug Administration Act (the FD&C Act). This action will
http://www.fda.gov/Drugs/Guidance streamline the review of all
[Docket No. FDA–2014–D–1953]
ComplianceRegulatoryInformation/ manufacturing establishments involved
Guidances/default.htm or https:// Providing Regulatory Submissions in in the preparation of a drug or biological
www.regulations.gov. Electronic Format—Submission of product by consolidating information in
Dated: December 22, 2016. Manufacturing Establishment one location and eliminating the
Leslie Kux,
Information; Draft Guidance for inclusion of erroneous and/or outdated
Industry; Availability information from other Agency files.
Associate Commissioner for Policy.
[FR Doc. 2016–31513 Filed 12–28–16; 8:45 am] AGENCY: Food and Drug Administration, DATES: Although you can comment on
BILLING CODE 4164–01–P
HHS. any guidance at any time (see 21 CFR
ACTION: Notice of availability. 10.115(g)(5)), to ensure that the Agency
SUMMARY: The Food and Drug considers your comment on this draft
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Administration (FDA or Agency) is guidance before it begins work on the
announcing the availability of a draft final version of the guidance, submit
guidance for industry entitled either electronic or written comments
‘‘Providing Regulatory Submissions in on the draft guidance by February 27,
Electronic Format—Submission of 2017.
Manufacturing Establishment
Information.’’ This guidance discusses ADDRESSES: You may submit comments
the requirements for a valid electronic as follows:
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Document Created: 2016-12-29 01:58:58
Document Modified: 2016-12-29 01:58:58
| 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 February 27, 2017. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by February 27, 2017. | |
| Contact | Edisa Gozun, 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 | 81 FR 96011 |
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