80 FR 65768 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 207 (October 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 207 (October 27, 2015)
| Page Range | 65768-65769 | |
| FR Document | 2015-27268 |
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)] [Notices] [Pages 65768-65769] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27268] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3539] Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 28, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your [[Page 65769]] comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). 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-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' A new section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug Quality and Security Act (Pub. L. 113-54) in 2013, describes the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility does not compound drug products using a bulk drug substance unless: (1) It appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (see section 503B(a)(2)(A)(i) of the FD&C Act) or (2) the drug product compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act). This guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product from a bulk drug substance that does not appear on a list of bulk drug substances that may be used in compounding and is not used to compound a drug product that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding under section 503B(a)(2)(A)(i) of the FD&C Act. Elsewhere in this issue of the Federal Register, the Agency is making available for public comment a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act,'' which describes the conditions under which FDA does not intend to take action against a licensed pharmacist at a State-licensed pharmacy or a Federal facility for compounding a drug product from a bulk drug substance that cannot otherwise be used in compounding under section 503A of the FD&C Act while FDA develops the list of bulk drug substances that can be used in compounding under section 503A(b)(1)(A)(i)(III). II. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: October 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27268 Filed 10-26-15; 8:45 am] BILLING CODE 4164-01-P
![65768 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
Column A—What information is requested? Column B—Put data specific to the nominated substance
What is the chemical grade of the substance? Provide the chemical grade.
What is the strength, quality, stability, and purity of the ingredient? Provide the strength, quality, stability, and purity information and attach
a certificate of analysis.
How is the ingredient supplied? Describe how the ingredient is supplied (e.g., powder, liquid).
Is the substance recognized in foreign pharmacopeias or registered in List the foreign pharmacopeias or other countries in which it is reg-
other countries? istered.
Has information been submitted about the substance to the USP for Put yes, no, or unknown. If yes, state the status of the monograph, if
consideration of drug monograph development? known.
What dosage form(s) will be compounded using the bulk drug sub- State the dosage form(s).
stance?
What strength(s) will be compounded from the nominated substance? List the strength(s) of the drug product(s) that will be compounded from
the nominated substance, or a range of strengths, if known.
What are the anticipated route(s) of administration of the compounded List the route(s) of administration of the compounded drug product(s).
drug product(s)?
Are there safety and efficacy data on compounded drugs using the Provide a bibliography of safety and efficacy data for the drug com-
nominated substance? pounded using the nominated substance, if available, including any
relevant peer-reviewed medical literature.
Has the bulk drug substance been used previously to compound drug Describe past uses of the bulk drug substance in compounding.
product(s)?
What is the proposed use for the drug product(s) to be compounded Provide information on the proposed use of the compounded drug
with the nominated substance? product.
What is the reason for use of a compounded drug product rather than Provide a rationale for the use of a compounded drug product.
an FDA-approved product?
Is there any other relevant information? Provide any other information you would like FDA to consider in evalu-
ating the nomination.
In addition to nominating new Information in the docket will be in compounding under the Federal
substances or renominating substances publicly available. Therefore, we Food, Drug, and Cosmetic Act (the
previously nominated without sufficient remind nominators and commenters not FD&C Act). When final, the guidance
supporting information, individuals and to submit personal or confidential will reflect the Agency’s current
organizations will be able to comment information. thinking on the issues addressed by the
via the docket established by this notice Dated: October 21, 2015. guidance.
on substances nominated for the 503A Leslie Kux, DATES: Although you can comment on
bulks list that have not yet been Associate Commissioner for Policy. any guidance at any time (see 21 CFR
addressed in a Notice of Proposed 10.115(g)(5)), to ensure that the Agency
[FR Doc. 2015–27271 Filed 10–26–15; 8:45 am]
Rulemaking (NPRM). Comments may be considers your comment on this draft
BILLING CODE 4164–01–P
submitted regarding nominations guidance before it begins work on the
submitted to both this docket and final version of the guidance, submit
Docket No. FDA–2013–N–1525. either electronic or written comments
DEPARTMENT OF HEALTH AND
Comments may provide any relevant on the draft guidance by December 28,
HUMAN SERVICES
information about particular bulk drug 2015.
substances, including that in support of, Food and Drug Administration
or in opposition to, the placement of a ADDRESSES: You may submit comments
nominated bulk drug substance on the [Docket No. FDA–2015–D–3539] as follows:
503A bulks list. However, comments Electronic Submissions
submitted should not address the 503A Interim Policy on Compounding Using
bulks list generally or other matters Bulk Drug Substances Under Section Submit electronic comments in the
related to the Agency’s regulation of 503B of the Federal Food, Drug, and following way:
compounding. Comments about Cosmetic Act; Draft Guidance for
• Federal eRulemaking Portal: http://
nominated substances that have been Industry; Availability
www.regulations.gov. Follow the
addressed by the Agency in an NPRM AGENCY: Food and Drug Administration, instructions for submitting comments.
should be submitted to the docket for HHS. Comments submitted electronically,
the proposed rulemaking in which the including attachments, to http://
substance is addressed. ACTION: Notice of availability.
www.regulations.gov will be posted to
Please do not submit comments that SUMMARY: The Food and Drug the docket unchanged. Because your
have already been submitted to other Administration (FDA or the Agency) is comment will be made public, you are
dockets. Such submissions are announcing the availability of a draft solely responsible for ensuring that your
duplicative and not helpful to the guidance entitled ‘‘Interim Policy on comment does not include any
Agency. If comments on particular Compounding Using Bulk Drug confidential information that you or a
documents or issues are submitted to Substances Under Section 503B of the third party may not wish to be posted,
tkelley on DSK3SPTVN1PROD with NOTICES
this docket rather than the docket Federal Food, Drug, and Cosmetic Act.’’ such as medical information, your or
specifically opened for the particular The draft guidance describes FDA’s anyone else’s Social Security number, or
document or issue, the comment might interim regulatory policy regarding confidential business information, such
not be considered as the specific outsourcing facilities that compound as a manufacturing process. Please note
documents are being finalized and human drug products using bulk drug that if you include your name, contact
issues considered. FDA will not respond substances while FDA develops the list information, or other information that
to questions submitted to this docket. of bulk drug substances that can be used identifies you in the body of your
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![Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65769
comments, that information will be will not be disclosed except in products using a bulk drug substance
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other unless: (1) It appears on a list
• If you want to submit a comment applicable disclosure law. For more established by the Secretary identifying
with confidential information that you information about FDA’s posting of bulk drug substances for which there is
do not wish to be made available to the comments to public dockets, see 80 FR a clinical need (see section
public, submit the comment as a 56469, September 18, 2015, or access 503B(a)(2)(A)(i) of the FD&C Act) or (2)
written/paper submission and in the the information at: http://www.fda.gov/ the drug product compounded from
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ such bulk drug substances appears on
Submissions’’ and ‘‘Instructions’’). default.htm. the drug shortage list in effect under
Written/Paper Submissions Docket: For access to the docket to section 506E of the FD&C Act (21 U.S.C.
read background documents or the 356e) at the time of compounding,
Submit written/paper submissions as electronic and written/paper comments
follows: distribution, and dispensing (see section
received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
503B(a)(2)(A)(ii) of the FD&C Act).
written/paper submissions): Division of docket number, found in brackets in the This guidance describes the
Dockets Management (HFA–305), Food heading of this document, into the conditions under which FDA does not
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts intend to take action against an
Lane, Rm. 1061, Rockville, MD 20852. outsourcing facility for compounding a
and/or go to the Division of Dockets
• For written/paper comments
Management, 5630 Fishers Lane, Rm. drug product from a bulk drug
submitted to the Division of Dockets
Management, FDA will post your 1061, Rockville, MD 20852. substance that does not appear on a list
Submit written requests for single of bulk drug substances that may be
comment, as well as any attachments,
except for information submitted, copies of this guidance to the Division used in compounding and is not used to
marked and identified, as confidential, of Drug Information, Center for Drug compound a drug product that appears
if submitted as detailed in Evaluation and Research, Food and on the FDA drug shortage list at the time
‘‘Instructions.’’ Drug Administration, 10001 New of compounding, distribution, and
Instructions: All submissions received Hampshire Ave., Hillandale Building, dispensing, while FDA develops the list
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– of bulk drug substances that can be used
2015–D–3539 for ‘‘Interim Policy on 0002. Send one self-addressed adhesive in compounding under section
Compounding Using Bulk Drug label to assist that office in processing 503B(a)(2)(A)(i) of the FD&C Act.
Substances Under Section 503B of the your requests. See the SUPPLEMENTARY
INFORMATION section for electronic Elsewhere in this issue of the Federal
Federal Food, Drug, and Cosmetic Act; Register, the Agency is making available
Draft Guidance for Industry; access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sara for public comment a draft guidance
Availability.’’ Received comments will
Rothman, Center for Drug Evaluation entitled ‘‘Interim Policy on
be placed in the docket and, except for
those submitted as ‘‘Confidential and Research, Food and Drug Compounding Using Bulk Drug
Submissions,’’ publicly viewable at Administration, 10903 New Hampshire Substances Under Section 503A of the
http://www.regulations.gov or at the Ave. Bldg. 51, Rm. 5197, Silver Spring, Federal Food, Drug, and Cosmetic Act,’’
Division of Dockets Management MD 20993–0002, 301–796–3110. which describes the conditions under
between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: which FDA does not intend to take
through Friday. action against a licensed pharmacist at
• Confidential Submissions—To I. Background a State-licensed pharmacy or a Federal
submit a comment with confidential FDA is announcing the availability of facility for compounding a drug product
information that you do not wish to be a draft guidance entitled ‘‘Interim Policy from a bulk drug substance that cannot
made publicly available, submit your on Compounding Using Bulk Drug otherwise be used in compounding
comments only as a written/paper Substances Under Section 503B of the under section 503A of the FD&C Act
submission. You should submit two Federal Food, Drug, and Cosmetic Act.’’ while FDA develops the list of bulk
copies total. One copy will include the A new section 503B (21 U.S.C. 353b), drug substances that can be used in
information you claim to be confidential added to the FD&C Act by the Drug compounding under section
with a heading or cover note that states Quality and Security Act (Pub. L. 113– 503A(b)(1)(A)(i)(III).
‘‘THIS DOCUMENT CONTAINS 54) in 2013, describes the conditions
CONFIDENTIAL INFORMATION.’’ The that must be satisfied for human drug II. Electronic Access
Agency will review this copy, including products compounded by an
Persons with access to the Internet
the claimed confidential information, in outsourcing facility to be exempt from
its consideration of comments. The the following three sections of the FD&C may obtain the guidance at either
second copy, which will have the Act: Section 505 (21 U.S.C. 355) http://www.fda.gov/Drugs/Guidance
claimed confidential information (concerning the approval of drugs under ComplianceRegulatoryInformation/
redacted/blacked out, will be available new drug applications or abbreviated Guidances/default.htm or http://
for public viewing and posted on new drug applications); section 502(f)(1) www.regulations.gov.
http://www.regulations.gov. Submit (21 U.S.C. 352(f)(1)) (concerning the Dated: October 21, 2015.
both copies to the Division of Dockets labeling of drugs with adequate Leslie Kux,
Management. If you do not wish your directions for use); and section 582 (21 Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
name and contact information to be U.S.C. 360eee-1) (concerning drug
[FR Doc. 2015–27268 Filed 10–26–15; 8:45 am]
made publicly available, you can supply chain security requirements).
provide this information on the cover One of the conditions that must be met BILLING CODE 4164–01–P
sheet and not in the body of your for a drug product compounded by an
comments and you must identify this outsourcing facility to qualify for these
information as ‘‘confidential.’’ Any exemptions is that the outsourcing
information marked as ‘‘confidential’’ facility does not compound drug
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Document Created: 2015-12-14 15:35:57
Document Modified: 2015-12-14 15:35:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | 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 December 28, 2015. | |
| Contact | Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110. | |
| FR Citation | 80 FR 65768 |
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