82 FR 35214 - Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 144 (July 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35214-35216 | |
| FR Document | 2017-15900 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Notices] [Pages 35214-35216] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15900] [[Page 35214]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2562] Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of public docket. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is developing a list of drug products and categories of drug products that present demonstrable difficulties for compounding (the Difficult to Compound List). The Agency previously solicited nominations for this list and received approximately 71 unique nominations. FDA is establishing a new public docket so that interested parties can nominate drug products or categories of drug products that were not previously nominated for inclusion on the Difficult to Compound List, resubmit previous nominations with additional supporting information, or submit comments. DATES: Nominations for the Difficult to Compound List and comments may be submitted to this docket at any time. ADDRESSES: You may submit nominations or comments as follows: Electronic Submissions Submit electronic nominations or comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting nominations or comments. Nominations or comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your nomination or comment will be made public, you are solely responsible for ensuring that your nomination or 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 nomination or comments, that information will be posted on https://www.regulations.gov. If you want to submit a nomination or comment with confidential information that you do not wish to be made available to the public, submit the nomination or 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 nominations or comments submitted to the Division of Dockets Management, FDA will post your nomination or 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. [Docket No. FDA-2017-N-2562] for ``Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket.'' Received nominations and 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 nomination or comment with confidential information that you do not wish to be made publicly available, submit your nomination or 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 nominations or 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 nomination or comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper nominations and 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. FOR FURTHER INFORMATION CONTACT: Pawanprit Singh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5206, Silver Spring, MD 20993-0002, 240- 402-8866. SUPPLEMENTARY INFORMATION: I. Background Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions under which a human drug product compounded for an identified individual patient based on a prescription qualifies for exemption from three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications). One of the conditions for these exemptions is that the compounded drug product is not ``a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product'' (section 503A(b)(3)(A) of the FD&C Act). Section 503A(c)(1) of the FD&C Act requires that, before issuing regulations to implement section 503A(b)(3)(A) of the FD&C Act, an advisory committee on compounding be convened and consulted ``unless the Secretary determines that the issuance of such [[Page 35215]] regulations before consultation is necessary to protect the public health.'' Section 503B of the FD&C Act (21 U.S.C. 353b) describes the conditions that must be met for human drugs compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from three sections of the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1)); (2) section 505 (21 U.S.C. 355); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). Section 503B does not provide an exemption from section 501(a)(2)(B). One of the conditions in section 503B that must be satisfied for a compounded drug to qualify for the exemptions in that section is that the drug either (1) is not identified (directly or as part of a category of drugs) on a list published by the Secretary, of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients, or (2) is compounded in accordance with all applicable conditions identified on the list as conditions that are necessary to prevent the drug or category of drugs from presenting such demonstrable difficulties (see section 503B(a)(6)(A) and (a)(6)(B) of the FD&C Act). Section 503B(c)(2) of the FD&C Act requires that before issuing regulations to implement section 503B(a)(6) of the FD&C Act, an advisory committee on compounding be convened and consulted. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee (PCAC)) discussed and provided FDA with advice about the Agency's efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act. FDA published a notice of that meeting in the Federal Register on June 29, 2000 (65 FR 40104). In the Federal Register of December 4, 2013 (78 FR 72840), FDA invited all interested persons to nominate drug products or categories of drug products for inclusion on the Difficult to Compound List. Nominators were asked to include the name of the drug product or category of drug products being nominated, as well as the reason the drug product or category of drug products should be included on the list, taking into account the risks and benefits to patients. The notice also included a list of factors that may be relevant to determining whether or not a drug product or category of drug products should or should not be included on the Difficult to Compound List. Approximately 71 unique drug products or categories of drug products were nominated for this list. On June 18, 2015, the PCAC reviewed and discussed FDA's proposed criteria for evaluating whether drug products or categories of drug products are demonstrably difficult to compound under sections 503A and 503B of the FD&C Act. After considering the PCAC's discussion, FDA refined the criteria and presented the changes to the PCAC on March 9, 2016. The six criteria presented to the PCAC for evaluating whether a drug product or category of drug products is demonstrably difficult to compound are the following: (1) The complexity of the formulation; (2) the complexity of the drug delivery mechanism; (3) the complexity of the dosage form; (4) the complexity of achieving bioavailability; (5) the complexity of the compounding process; and (6) the complexity of physicochemical or analytical testing. Additional information regarding these criteria can be found in the briefing package for the March 2016 PCAC meeting. See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM486146.pdf. II. Establishment of a Public Docket FDA is establishing a public docket so that interested parties can nominate drug products or categories of drug products for inclusion on the Difficult to Compound List, resubmit previous nominations with additional supporting information, or submit comments. Nominations should include the following two items for each drug product or category of drug products nominated, and any other relevant additional information available: The name of the drug product or drug product category; The reason the drug product or drug product category should be included on the list, taking into account any risks and benefits to patients. To facilitate FDA's review, nominations may include responses to the following six questions, which are related to the criteria FDA presented to the PCAC for evaluating whether drug products and categories of drug products are difficult to compound under sections 503A and 503B of the FD&C Act: 1. Does the drug product or category of drug products have a complex formulation that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? 2. Does the drug product or category of drug products have a complex drug delivery mechanism that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? 3. Does the drug product or category of drug products involve a complex dosage form that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? 4. Does the drug product or category of drug products involve complexities in achieving and/or assessing bioavailability that present a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? 5. Does compounding the drug product or category of drug products involve a complex compounding process that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? 6. Does compounding the drug product or category of drug products necessitate complex physicochemical or analytical testing that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product? It is not necessary for a previously nominated drug product or category of drug products to be renominated to this docket. Previously nominated drug products or categories of drug products may be renominated to this docket if the nominator wants to provide additional supporting information, e.g., information specific to the six questions listed above related to FDA's proposed evaluation criteria. Interested parties can also submit comments on nominated drug products or categories of drug products, or on this document, via this docket. Previous nominations to the Difficult to Compound List or comments submitted in response to the December 4, 2013 Federal Register notice can be viewed on https://www.regulations.gov under docket number FDA- 2013-N-1523, or by going to the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. [[Page 35216]] Dated: July 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15900 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
![35214 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
DEPARTMENT OF HEALTH AND • If you want to submit a nomination information as ‘‘confidential.’’ Any
HUMAN SERVICES or comment with confidential information marked as ‘‘confidential’’
information that you do not wish to be will not be disclosed except in
Food and Drug Administration made available to the public, submit the accordance with 21 CFR 10.20 and other
nomination or comment as a written/ applicable disclosure law. For more
[Docket No. FDA–2017–N–2562] paper submission and in the manner information about FDA’s posting of
Drug Products That Present detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
Demonstrable Difficulties for Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
Compounding Under the Federal Food, Written/Paper Submissions the information at: https://www.gpo.gov/
Drug, and Cosmetic Act; fdsys/pkg/FR-2015-09-18/pdf/2015-
Submit written/paper submissions as 23389.pdf.
Establishment of a Public Docket follows: Docket: For access to the docket to
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for read background documents or the
HHS. written/paper submissions): Division of electronic and written/paper
Dockets Management (HFA–305), Food nominations and comments received, go
ACTION: Notice; establishment of public and Drug Administration, 5630 Fishers
docket. to https://www.regulations.gov and
Lane, Rm. 1061, Rockville, MD 20852. insert the docket number, found in
SUMMARY: The Food and Drug • For written/paper nominations or brackets in the heading of this
Administration (FDA or Agency) is comments submitted to the Division of
document, into the ‘‘Search’’ box and
developing a list of drug products and Dockets Management, FDA will post
follow the prompts and/or go to the
categories of drug products that present your nomination or comment, as well as
Division of Dockets Management, 5630
demonstrable difficulties for any attachments, except for information
Fishers Lane, Rm. 1061, Rockville, MD
compounding (the Difficult to submitted, marked and identified, as
20852.
Compound List). The Agency previously confidential, if submitted as detailed in
‘‘Instructions.’’ FOR FURTHER INFORMATION CONTACT:
solicited nominations for this list and Pawanprit Singh, Center for Drug
Instructions: All submissions received
received approximately 71 unique Evaluation and Research, Food and
must include the Docket No. [Docket
nominations. FDA is establishing a new No. FDA–2017–N–2562] for ‘‘Drug Drug Administration, 10903 New
public docket so that interested parties Products That Present Demonstrable Hampshire Ave., Bldg. 51, Rm. 5206,
can nominate drug products or Difficulties for Compounding Under Silver Spring, MD 20993–0002, 240–
categories of drug products that were Sections 503A and 503B of the Federal 402–8866.
not previously nominated for inclusion Food, Drug, and Cosmetic Act; SUPPLEMENTARY INFORMATION:
on the Difficult to Compound List, Establishment of a Public Docket.’’
resubmit previous nominations with I. Background
Received nominations and comments
additional supporting information, or will be placed in the docket and, except Section 503A of the Federal Food,
submit comments. for those submitted as ‘‘Confidential Drug, and Cosmetic Act (FD&C Act) (21
DATES: Nominations for the Difficult to Submissions,’’ publicly viewable at U.S.C. 353a) describes the conditions
Compound List and comments may be https://www.regulations.gov or at the under which a human drug product
submitted to this docket at any time. Division of Dockets Management compounded for an identified
ADDRESSES: You may submit between 9 a.m. and 4 p.m., Monday individual patient based on a
nominations or comments as follows: through Friday. prescription qualifies for exemption
• Confidential Submissions—To from three sections of the FD&C Act: (1)
Electronic Submissions submit a nomination or comment with Section 501(a)(2)(B) (21 U.S.C.
Submit electronic nominations or confidential information that you do not 351(a)(2)(B)) (concerning current good
comments in the following way: wish to be made publicly available, manufacturing practice for drugs); (2)
• Federal eRulemaking Portal: submit your nomination or comments section 502(f)(1) (21 U.S.C. 352(f)(1))
https://www.regulations.gov. Follow the only as a written/paper submission. You (concerning the labeling of drugs with
instructions for submitting nominations should submit two copies total. One adequate directions for use); and (3)
or comments. Nominations or comments copy will include the information you section 505 (21 U.S.C. 355) (concerning
submitted electronically, including claim to be confidential with a heading the approval of human drug products
attachments, to https:// or cover note that states ‘‘THIS under new drug applications or
www.regulations.gov will be posted to DOCUMENT CONTAINS abbreviated new drug applications). One
the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The of the conditions for these exemptions
nomination or comment will be made Agency will review this copy, including is that the compounded drug product is
public, you are solely responsible for the claimed confidential information, in not ‘‘a drug product identified by the
ensuring that your nomination or its consideration of nominations or Secretary by regulation as a drug
comment does not include any comments. The second copy, which will product that presents demonstrable
confidential information that you or a have the claimed confidential difficulties for compounding that
third party may not wish to be posted, information redacted/blacked out, will reasonably demonstrate an adverse
such as medical information, your or be available for public viewing and effect on the safety or effectiveness of
asabaliauskas on DSKBBXCHB2PROD with NOTICES
anyone else’s Social Security number, or posted on https://www.regulations.gov. that drug product’’ (section
confidential business information, such Submit both copies to the Division of 503A(b)(3)(A) of the FD&C Act). Section
as a manufacturing process. Please note Dockets Management. If you do not 503A(c)(1) of the FD&C Act requires
that if you include your name, contact wish your name and contact that, before issuing regulations to
information, or other information that information to be made publicly implement section 503A(b)(3)(A) of the
identifies you in the body of your available, you can provide this FD&C Act, an advisory committee on
nomination or comments, that information on the cover sheet and not compounding be convened and
information will be posted on https:// in the body of your nomination or consulted ‘‘unless the Secretary
www.regulations.gov. comments and you must identify this determines that the issuance of such
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![35216 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
Dated: July 24, 2017. Comments submitted electronically, claimed confidential information
Anna K. Abram, including attachments, to https:// redacted/blacked out, will be available
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to for public viewing and posted on
Legislation, and Analysis. the docket unchanged. Because your https://www.regulations.gov. Submit
[FR Doc. 2017–15900 Filed 7–27–17; 8:45 am] comment will be made public, you are both copies to the Dockets Management
BILLING CODE 4164–01–P solely responsible for ensuring that your Staff. If you do not wish your name and
comment does not include any contact information to be made publicly
confidential information that you or a available, you can provide this
DEPARTMENT OF HEALTH AND third party may not wish to be posted, information on the cover sheet and not
HUMAN SERVICES such as medical information, your or in the body of your comments and you
anyone else’s Social Security number, or must identify this information as
Food and Drug Administration confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
[Docket No. FDA–2017–N–4301]
that if you include your name, contact except in accordance with 21 CFR 10.20
Fostering Medical Innovation: A Plan information, or other information that and other applicable disclosure law. For
for Digital Health Devices; Software identifies you in the body of your more information about FDA’s posting
Precertification Pilot Program comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, • If you want to submit a comment the information at: https://www.gpo.gov/
HHS. with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice. do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
SUMMARY: The Food and Drug written/paper submission and in the read background documents or the
Administration’s (FDA, the Agency, or manner detailed (see ‘‘Written/Paper electronic and written/paper comments
we) Center for Devices and Radiological Submissions’’ and ‘‘Instructions’’). received, go to https://
Health (CDRH or Center) is announcing www.regulations.gov and insert the
Written/Paper Submissions
its Software Precertification Pilot docket number, found in brackets in the
Program. The program aims to evaluate Submit written/paper submissions as heading of this document, into the
a new approach toward software follows: ‘‘Search’’ box and follow the prompts
products, including a precertification • Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
program for the assessment of written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
companies that perform high-quality Management Staff (HFA–305), Food and
Rockville, MD 20852.
software design and testing. This Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
voluntary pilot program is part of FDA’s
ongoing efforts to develop pragmatic • For written/paper comments Bakul Patel, Center for Devices and
submitted to the Dockets Management Radiological Health, Food and Drug
approaches to balance benefits and risks Administration, 10903 New Hampshire
of digital health products. FDA intends Staff, FDA will post your comment, as
well as any attachments, except for Ave., Bldg. 66, Rm. 5458, Silver Spring,
to develop a precertification program MD 20993, 301–796–5528, Bakul.Patel@
that could replace the need for a information submitted, marked and
identified, as confidential, if submitted fda.hhs.gov.
premarket submission in some cases
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
and allow for decreased submission
content and/or faster review of Instructions: All submissions received
I. Background
marketing applications for software must include the Docket No. FDA–
2017–N–4301 for ‘‘Fostering Medical FDA recognizes that an efficient, risk-
products in other cases. During the pilot
Innovation: A Plan for Digital Health based approach to regulating digital
program, FDA customers, including
Devices; Software Precertification Pilot health technology will foster innovation
pilot participants, will have the
Program.’’ Received comments will be of digital health products. FDA’s
opportunity to provide input on the
placed in the docket and, except for traditional approach to moderate and
development of the precertification
those submitted as ‘‘Confidential higher risk hardware-based medical
program.
Submissions,’’ publicly viewable at devices is not well suited for the faster
DATES: FDA is seeking participation in https://www.regulations.gov or at the iterative design, development, and type
the voluntary Software Precertification Dockets Management Staff between 9 of validation used for software products.
pilot program beginning August 1, 2017. a.m. and 4 p.m., Monday through An agile paradigm is necessary to
See the ‘‘Participation’’ section for Friday. accommodate the faster rate of
instructions on how to submit a request • Confidential Submissions—To development and innovation of software
to participate. The voluntary Software submit a comment with confidential devices as compared to other types of
Precertification pilot program will select information that you do not wish to be devices. Traditional implementation of
up to nine participants who best match made publicly available, submit your the premarket requirements may impede
the selection criteria. This pilot program comments only as a written/paper or delay patient access to critical
will begin September 1, 2017. submission. You should submit two evolutions of software technology,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ADDRESSES: You may submit comments copies total. One copy will include the particularly those presenting a lower
as follows: information you claim to be confidential risk to patients. To evaluate a new
with a heading or cover note that states approach toward software, FDA is
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS launching a pilot of a precertification
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The program for the assessment of
following way: Agency will review this copy, including companies that perform high-quality
• Federal eRulemaking Portal: the claimed confidential information, in software design and testing. The
https://www.regulations.gov. Follow the its consideration of comments. The Software Precertification (Pre-Cert) pilot
instructions for submitting comments. second copy, which will have the program is part of FDA’s ongoing efforts
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Document Created: 2017-07-28 03:10:54
Document Modified: 2017-07-28 03:10:54
| 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; establishment of public docket. | |
| Dates | Nominations for the Difficult to Compound List and comments may be submitted to this docket at any time. | |
| Contact | Pawanprit Singh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5206, Silver Spring, MD 20993-0002, 240- 402-8866. | |
| FR Citation | 82 FR 35214 |
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