80 FR 65770 - Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of 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 80, Issue 207 (October 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 207 (October 27, 2015)
| Page Range | 65770-65774 | |
| FR Document | 2015-27270 |
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)] [Notices] [Pages 65770-65774] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27270] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3469] Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; establishment of public docket. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (the 503B bulks list). The Agency previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for FDA to evaluate them. FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to [[Page 65771]] receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503B bulks list. Interested parties can also submit comments on nominated substances via this docket. DATES: Nominations and comments may be submitted to this docket at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). 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-N-3469 for ``Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket.'' 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. FOR FURTHER INFORMATION CONTACT: Philantha Bowen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301- 796-2466. SUPPLEMENTARY INFORMATION: I. Background Under the Drug Quality and Security Act (Pub. L. 113-54), which added a new section 503B to the FD&C Act (21 U.S.C. 353b), outsourcing facilities \1\ may qualify for certain exemptions from the FD&C Act if the conditions set forth in the statute are satisfied. Those conditions include that an outsourcing facility does not compound drug products using a bulk drug substance unless the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or the drug product compounded from such bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) (FDA drug shortage list) at the time of compounding, distribution, and dispensing, and each of the following conditions are met: (1) If an applicable monograph exists under the United States Pharmacopeia (USP), the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substance complies with the monograph; (2) the bulk drug substance is manufactured by an establishment that is registered under section 510 of the FD&C Act (21 U.S.C. 360); and (3) the bulk drug substance is accompanied by a valid certificate of analysis (see section 503B(a)(2) of the FD&C Act). --------------------------------------------------------------------------- \1\ ``Outsourcing facilities'' are facilities that meet certain conditions described in section 503B of the FD&C Act, including registering with FDA as an outsourcing facility. --------------------------------------------------------------------------- Section 503B refers to the definition of ``bulk drug substance'' in FDA regulations at Sec. 207.3(a)(4) (21 CFR 207.3(a)(4)). (See section 503B(a)(2) of the FD&C Act.) As defined in Sec. 207.3(a)(4), a ``bulk drug substance'' is any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances. An ``active ingredient'' is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (See Sec. 210.3(b)(7) (21 CFR 210.3(b)(7)).) [[Page 65772]] Any component other than an active ingredient is an ``inactive ingredient.'' (See Sec. 210.3(b)(8).) Inactive ingredients used in compounded drug products, which commonly include flavorings, dyes, diluents, or other excipients, need not appear on the Secretary's list of bulk drug substances to be eligible for use in compounding drug products and will not be included on the list. In a document dated November 27, 2013, published in the Federal Register of December 4, 2013 (78 FR 72838), FDA invited all interested persons to nominate bulk drug substances for inclusion on the 503B bulks list. Over 2,000 substances were nominated. However, many of the nominations were not for bulk drug substances used in compounding as active ingredients, or they did not include sufficient information to allow FDA to evaluate the nominated substances for placement on the list. To improve the efficiency of the process for developing the 503B bulks list, FDA reopened the nomination process in July 2014 (79 FR 37747, July 2, 2014), and provided more detailed information on what it needs to evaluate nominations for the list. FDA stated that bulk drug substances that were previously nominated would not be further considered unless they were renominated with adequate support to permit a meaningful evaluation. Substances that were already eligible for use in compounding or that were not adequately supported would not be evaluated for placement on the list. In response to the July 2, 2014, request for nominations, approximately 2,590 unique substances were nominated. Of the nominated substances, approximately 1,750 are not eligible for inclusion on the list because they are either a finished drug product, a biological product subject to licensure in a biologics license application (BLA), a radiopharmaceutical drug product, a substance with no currently accepted medical use that is included on Schedule I of the Controlled Substances Act (CSA) (21 U.S.C. 812(c)), or they appear on the list published by FDA of substances that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Of the substances that are not biological products subject to licensure in a BLA, finished drug products, radiopharmaceuticals, do not appear on Schedule I in the CSA, and do not appear on the withdrawn or removed list, approximately 650 substances were nominated with insufficient supporting evidence for FDA to evaluate them. II. Establishment of a Docket As described in section III.B of the draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act,'' FDA is establishing a public docket so that interested parties can comment on nominated bulk drug substances, nominate bulk drug substances that were not previously nominated for the 503B bulks list, or renominate with adequate supporting information bulk drug substances that were previously nominated but that were not supported by sufficient information for FDA to evaluate them. Docket No. FDA-2013-N-1524 is closed for comment. Therefore, this new docket can be used for commenting on nominations previously submitted to that docket as well as for submitting new nominations. In the Federal Register document seeking nominations, FDA stated that the following information about clinical need is necessary to provide adequate support for nominations to the 503B bulks list: A statement describing the medical condition(s) that the drug product to be compounded with the nominated bulk drug substances is intended to treat; A list of FDA-approved drug products, if any, that address the same medical condition; If there are any FDA-approved drug products that address the same medical condition, an explanation of why a compounded drug product is necessary; If the approved drug product is not suitable for a particular patient population, an estimate of the size of the population that would need a compounded drug product; A bibliography of safety and efficacy data for the drug product compounded using the nominated substance, if available, including any relevant peer-reviewed medical literature; and If there is an FDA-approved drug product that includes the bulk drug substance nominated, an explanation of why the drug product proposed to be compounded must be compounded from bulk rather than with the FDA-approved drug product. Therefore, to be considered for placement on the 503B bulks list, this information should be submitted for each nominated substance. Interested groups and individuals may nominate specific bulk drug substances for inclusion on the 503B bulks list, renominate previously nominated substances with additional information, or comment on nominated substances. Nominations will only be evaluated if they are for specific active ingredients that meet the definition of a bulk drug substance in Sec. 207.3(a)(4). Nominated substances that do not meet this definition will not be included on the list. To fully evaluate a bulk drug substance using the criteria identified in this document, FDA needs the following information about both the nominated bulk drug substance and the drug product(s) that will be compounded using such substance: A. Active Ingredients 1. Confirmation That the Nominated Substance Is a Bulk Drug Substance A statement that the nominated substance is an active ingredient that meets the definition of ``bulk drug substance'' in Sec. 207.3(a)(4), and an explanation of why the substance is considered an active ingredient when it is used in compounded drug products, citing specific sources that describe the active properties of the substance. 2. General Background on the Bulk Drug Substance Ingredient name; chemical name; common name(s); and identifying codes, as available, from FDA's Unique Ingredient Identifiers (UNII) used in the FDA/USP Substance Registration System, available at http://fdasis.nlm.nih.gov/srs/. Because substance names can vary, this code, where available, will be used by the Agency to confirm the exact substance nominated and to identify multiple nominations of the same substance so the information can be reviewed together. Chemical grade of the ingredient; description of the strength, quality, stability, and purity of the ingredient, and a copy of a certificate of analysis that is representative of the characteristics of the nominated ingredient; information about how the ingredient is supplied (e.g., powder, liquid); and information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development. B. Clinical Need To Compound For FDA to be able to meaningfully evaluate a substance, the information provided regarding the clinical need for compounding with a bulk drug substance must be specific to the particular substance nominated and [[Page 65773]] drug product to be compounded. A ``boilerplate'' or general explanation of clinical need for compounding with bulk drug substances will not enable FDA to conduct an adequate review. Prescribers of the compounded drug products who may be in the best position to explain why there is a clinical need for a compounded drug product may provide data in support of a nomination. The following information about clinical need is necessary to provide adequate support for nominations to the 503B bulks list: A statement describing the medical condition(s) that the drug product to be compounded with the nominated bulk drug substances is intended to treat (i.e., what patient need is met by the drug product compounded with the bulk drug substance); a list of FDA-approved drug products, if any, that address the same medical condition; if there are FDA-approved drug products that address the same medical condition, an explanation of why a compounded drug product is necessary (i.e., why the approved drug product is not suitable for a particular patient population); if the approved drug product is not suitable for a particular patient population, an estimate of the size of the population that would need a compounded drug product (e.g., for a drug product compounded from bulk because of patient allergies or other intolerances to excipients in FDA-approved drug products, FDA expects the supporting information to include a good faith estimate of the patient population with the specific medical condition that suffers from the allergy or intolerance, with citations to the literature regarding the incidence of the condition or a statement that a search was conducted and no references were found); \2\ --------------------------------------------------------------------------- \2\ For example, if there is a need to compound a drug product from bulk drug substances due to patient sensitivity to a preservative or other excipient in the approved drug product, the supporting data is expected to set forth the number of patients for whom the drug product is prescribed that are allergic or sensitive to that particular excipient. --------------------------------------------------------------------------- a bibliography of safety and efficacy data for the drug compounded using the nominated substance,\3\ if available, including any relevant peer-reviewed medical literature; and --------------------------------------------------------------------------- \3\ FDA recognizes that the available safety and efficacy data supporting consideration of a bulk drug substance for inclusion on the list may not be of the same type, amount, or quality as is required to support a new drug application. Note that data regarding safety and efficacy, while relevant, is not indicative of a clinical need for a particular bulk drug substance, and additional information regarding the clinical need must be provided. --------------------------------------------------------------------------- if there is an FDA-approved drug product that includes the bulk drug substance nominated, an explanation of why the drug product proposed to be compounded must be compounded from bulk rather than with the FDA-approved drug product. General or boilerplate statements regarding the need to compound from the bulk drug substance or the benefits of compounding generally will not be considered sufficient. Note that the Agency does not consider supply issues, such as backorders, that do not rise to the level of a drug shortage listed on FDA's drug shortage Web site as evidence of a clinical need for compounding with a bulk drug substance, and section 503B of the FD&C Act already allows compounding from bulk drug substances if the compounded drug product is on the FDA drug shortage list. Similarly, considerations of cost and convenience will not be considered indicators of clinical need. C. Information on the Drug Product That Will Be Compounded With the Bulk Drug Substance Information about the dosage form(s) into which the bulk drug substance will be compounded; information about the strength(s) of the compounded drug product(s); information about the anticipated route(s) of administration of the compounded drug product(s); and information about the previous use(s) of the compounded drug product(s). D. Process for Submitting Nominations and Comments Because the prior deadline for submitting nominations has passed, FDA is opening this docket so that interested persons can submit nominations of bulk drug substances and provide adequate support for FDA to evaluate whether those substances should be placed on the 503B bulks list. Bulk drug substances that were previously nominated and for which inadequate information was provided \4\ need to be renominated with the information identified in this document to be considered for inclusion on the 503B bulks list. Nominators are encouraged to submit as much of the information identified in this document as possible. Unless adequate supporting data is received for a bulk drug substance, FDA will be unable to consider it further for inclusion on the list. --------------------------------------------------------------------------- \4\ As referenced in this document, a list of the substances in this category is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467373.pdf. --------------------------------------------------------------------------- For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in an editable Excel file. Specifically, nominators are encouraged to format their nominations as follows: ------------------------------------------------------------------------ Column A--What information is Column B--Put data specific to requested? the nominated substance ------------------------------------------------------------------------ What is the name of the nominated Provide the ingredient name. ingredient? Is the ingredient an active ingredient Provide an explanation for why that meets the definition of ``bulk it is considered an active drug substance'' in Sec. ingredient when it is used in 207.3(a)(4)? specific compounded drug products, and provide citations to specific sources that describe its active properties. What is the chemical name of the Chemical name. substance? What is the common name of the Common name. substance? Does the substance have a UNII code? UNII code. What is the chemical grade of the Provide the chemical grade. substance? What is the strength, quality, Provide the strength, quality, stability, and purity of the stability, and purity ingredient? 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 List the foreign pharmacopeias pharmacopeias or registered in other or other countries in which it countries? is registered. Has information been submitted about Put yes, no, or unknown. If the substance to the USP for yes, state the status of the consideration of monograph monograph, if known. development? [[Page 65774]] What medical condition(s) is the drug Describe the medical product compounded with the bulk drug condition(s) that the drug substances intended to treat? product compounded with the bulk drug substances is intended to treat. Are there other drug products approved List the other approved by FDA to treat the same medical treatments. condition? If there are FDA-approved drug products Provide a justification for that address the same medical clinical need, including an condition, why is there a clinical estimate of the size of the need for a compounded drug product? population that would need the compounded drug. Are there safety and efficacy data on Provide a bibliography of compounded drugs using the nominated safety and efficacy data for substance? the drug compounded using the nominated substance, if available, including any relevant peer-reviewed medical literature. If there is an FDA-approved drug Provide an explanation of why product that includes the bulk drug it is necessary to compound substance nominated, is it necessary from the bulk drug substance. to compound a drug product from the bulk drug substance rather than from the FDA-approved drug product? What dosage form(s) will be compounded State the dosage form(s). using the bulk drug substance? What strength(s) will be compounded List the strength(s) of the from the nominated substance? 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 List the route(s) of administration of the compounded drug administration of the product(s)? compounded drug product(s). Has the bulk drug substance been used Describe previous uses of the previously to compound drug bulk drug substance in product(s)? compounding. Is there any other relevant Provide any other information information? you would like FDA to consider in evaluating the nomination. ------------------------------------------------------------------------ In addition to nominating new substances or renominating substances previously nominated without sufficient supporting information, individuals and organizations will be able to comment via the docket established by this notice on substances nominated for the 503B bulks list that have not yet been addressed in a Federal Register document proposing substances for the 503B bulks list. Comments may be submitted regarding nominations submitted to both this docket and nominations previously submitted to Docket No. FDA-2013-N-1524. Comments may provide any relevant information about particular bulk drug substances, including that in support of, or in opposition to, the placement of a nominated bulk drug substance on the 503B bulks list. However, comments submitted should not address the 503B bulks list generally or other matters related to the Agency's regulation of compounding. Comments about nominated substances that have been addressed by the Agency in a Federal Register document proposing substances for the 503B bulks list should be submitted to the docket for the document in which the substance is addressed. Please do not submit comments that have already been submitted to other dockets. Such submissions are duplicative and not helpful to the Agency. If comments on particular documents or issues are submitted to this docket rather than the docket specifically opened for the particular document or issue, the comment might not be considered as the specific documents are being finalized and issues considered. FDA will not respond to questions submitted to this docket. Information in the docket will be publicly available. Therefore, we remind nominators and commenters not to submit personal or confidential information. Dated: October 21, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27270 Filed 10-26-15; 8:45 am] BILLING CODE 4164-01-P
![65770 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
DEPARTMENT OF HEALTH AND years of age and younger. Codeine (most open public hearing session, FDA may
HUMAN SERVICES often in combination with conduct a lottery to determine the
acetaminophen) is used for the speakers for the scheduled open public
Food and Drug Administration treatment of pain in children; however, hearing session. The contact person will
[Docket No. FDA–2015–N–0001] it is contraindicated for the management notify interested persons regarding their
of pain after tonsillectomy and/or request to speak by November 17, 2015.
Joint Meeting of the Pulmonary-Allergy adenoidectomy. Codeine (in Persons attending FDA’s advisory
Drugs Advisory Committee and the combination with other medicines) is committee meetings are advised that the
Drug Safety and Risk Management used for the relief of cough associated Agency is not responsible for providing
Advisory Committee; Notice of Meeting with upper respiratory allergies or the access to electrical outlets.
common cold in children. FDA welcomes the attendance of the
AGENCY: Food and Drug Administration, Codeine is available by prescription public at its advisory committee
HHS. and also through the over-the-counter meetings and will make every effort to
ACTION: Notice. (OTC) Drug Monograph for Cold, Cough, accommodate persons with disabilities.
Allergy, Bronchodilator, and If you require accommodations due to a
This notice announces a forthcoming Antiasthmatic Drug Products (21 CFR disability, please contact Cindy Hong at
meeting of a public advisory committee 341.14, 21 CFR 341.74, and 21 CFR least 7 days in advance of the meeting.
of the Food and Drug Administration 341.90). FDA is committed to the orderly
(FDA). The meeting will be open to the The focus of the meeting will be the conduct of its advisory committee
public. risk of serious adverse events, such as meetings. Please visit our Web site at
Name of Committees: Pulmonary- respiratory depression and death, http://www.fda.gov/
Allergy Drugs Advisory Committee and including reports in children who are AdvisoryCommittees/
the Drug Safety and Risk Management CYP2D6 ultra-rapid metabolizers. The AboutAdvisoryCommittees/
Advisory Committee. committees will discuss whether the use
General Function of the Committees: ucm111462.htm for procedures on
of codeine in children should be public conduct during advisory
To provide advice and restricted further beyond the current
recommendations to the Agency on committee meetings.
contraindication described previously Notice of this meeting is given under
FDA’s regulatory issues. and whether codeine should be
Date and Time: The meeting will be the Federal Advisory Committee Act (5
available through the OTC Drug U.S.C. app. 2).
held on December 10, 2015, from 8 a.m. Monograph.
to 4 p.m. FDA intends to make background Dated: October 21, 2015.
Location: FDA White Oak Campus, material available to the public no later Leslie Kux,
10903 New Hampshire Ave., Bldg. 31 than 2 business days before the meeting. Associate Commissioner for Policy.
Conference Center, the Great Room (Rm. If FDA is unable to post the background [FR Doc. 2015–27196 Filed 10–26–15; 8:45 am]
1503), Silver Spring, MD 20993–0002. material on its Web site prior to the BILLING CODE 4164–01–P
Answers to commonly asked questions meeting, the background material will
including information regarding special be made publicly available at the
accommodations due to a disability, location of the advisory committee DEPARTMENT OF HEALTH AND
visitor parking, and transportation may meeting, and the background material HUMAN SERVICES
be accessed at: http://www.fda.gov/ will be posted on FDA’s Web site after
AdvisoryCommittees/ the meeting. Background material is Food and Drug Administration
AboutAdvisoryCommittees/ available at http://www.fda.gov/
[Docket No. FDA–2015–N–3469]
ucm408555.htm. AdvisoryCommittees/Calendar/
Contact Person: Cindy Hong, Center default.htm. Scroll down to the Bulk Drug Substances That Can Be
for Drug Evaluation and Research, Food appropriate advisory committee meeting Used To Compound Drug Products in
and Drug Administration, 10903 New link. Accordance With Section 503B of the
Hampshire Ave., Bldg. 31, Rm. 2417, Procedure: Interested persons may Federal Food, Drug, and Cosmetic Act;
Silver Spring, MD 20993–0002, 301– present data, information, or views, Establishment of a Public Docket
796–9001, FAX: 301–847–8533, orally or in writing, on issues pending
PADAC@fda.hhs.gov, or FDA Advisory before the committees. Written AGENCY: Food and Drug Administration,
Committee Information Line, 1–800– submissions may be made to the contact HHS.
741–8138 (301–443–0572 in the person on or before November 24, 2015. ACTION: Notice of availability;
Washington, DC area). A notice in the Oral presentations from the public will establishment of public docket.
Federal Register about last minute be scheduled between approximately 11
modifications that impact a previously a.m. and 12 p.m. Those individuals SUMMARY: The Food and Drug
announced advisory committee meeting interested in making formal oral Administration (FDA or Agency) is
cannot always be published quickly presentations should notify the contact developing a list of bulk drug
enough to provide timely notice. person and submit a brief statement of substances (active ingredients) that can
Therefore, you should always check the the general nature of the evidence or be used to compound drug products in
Agency’s Web site at http:// arguments they wish to present, the accordance with the Federal Food, Drug,
www.fda.gov/AdvisoryCommittees/ names and addresses of proposed and Cosmetic Act (the FD&C Act) (the
default.htm and scroll down to the participants, and an indication of the 503B bulks list). The Agency previously
tkelley on DSK3SPTVN1PROD with NOTICES
appropriate advisory committee meeting approximate time requested to make solicited nominations for the list, but
link, or call the advisory committee their presentation on or before some of the nominated substances were
information line to learn about possible November 16, 2015. Time allotted for not supported by sufficient information
modifications before coming to the each presentation may be limited. If the for FDA to evaluate them. FDA is
meeting. number of registrants requesting to establishing a public docket where these
Agenda: The committees will discuss speak is greater than can be reasonably substances can be renominated with
the safety of codeine in children 18 accommodated during the scheduled sufficient supporting information or to
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![65774 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 medical condition(s) is the drug product compounded with the Describe the medical condition(s) that the drug product compounded
bulk drug substances intended to treat? with the bulk drug substances is intended to treat.
Are there other drug products approved by FDA to treat the same med- List the other approved treatments.
ical condition?
If there are FDA-approved drug products that address the same med- Provide a justification for clinical need, including an estimate of the size
ical condition, why is there a clinical need for a compounded drug of the population that would need the compounded drug.
product?
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.
If there is an FDA-approved drug product that includes the bulk drug Provide an explanation of why it is necessary to compound from the
substance nominated, is it necessary to compound a drug product bulk drug substance.
from the bulk drug substance rather than from the FDA-approved
drug product?
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)?
Has the bulk drug substance been used previously to compound drug Describe previous uses of the bulk drug substance in compounding.
product(s)?
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 documents are being finalized and from human specimens intended for
substances or renominating substances issues considered. FDA will not respond prescription use or over-the-counter use.
previously nominated without sufficient to questions submitted to this docket. These devices are intended for
supporting information, individuals and Information in the docket will be autosomal recessive disease carrier
organizations will be able to comment publicly available. Therefore, we screening in adults of reproductive age.
via the docket established by this notice remind nominators and commenters not These devices are not intended for copy
on substances nominated for the 503B to submit personal or confidential number variation, cytogenetic, or
bulks list that have not yet been information. biochemical testing. FDA is publishing
addressed in a Federal Register Dated: October 21, 2015. this notice in order to obtain comments
document proposing substances for the Leslie Kux,
regarding the proposed exemption.
503B bulks list. Comments may be DATES: Submit electronic or written
Associate Commissioner for Policy.
submitted regarding nominations comments by November 27, 2015.
[FR Doc. 2015–27270 Filed 10–26–15; 8:45 am]
submitted to both this docket and ADDRESSES: You may submit comments
nominations previously submitted to BILLING CODE 4164–01–P
as follows:
Docket No. FDA–2013–N–1524.
Comments may provide any relevant Electronic Submissions
DEPARTMENT OF HEALTH AND
information about particular bulk drug Submit electronic comments in the
HUMAN SERVICES
substances, including that in support of, following way:
or in opposition to, the placement of a Food and Drug Administration • Federal eRulemaking Portal: http://
nominated bulk drug substance on the www.regulations.gov. Follow the
503B bulks list. However, comments [Docket No. FDA–2015–N–3455] instructions for submitting comments.
submitted should not address the 503B Comments submitted electronically,
bulks list generally or other matters Medical Devices; Exemptions From
including attachments, to http://
related to the Agency’s regulation of Premarket Notifications; Class II
www.regulations.gov will be posted to
compounding. Comments about Devices; Autosomal Recessive Carrier
the docket unchanged. Because your
nominated substances that have been Screening Gene Mutation Detection
comment will be made public, you are
addressed by the Agency in a Federal System; Request for Comments
solely responsible for ensuring that your
Register document proposing AGENCY: Food and Drug Administration, comment does not include any
substances for the 503B bulks list HHS. confidential information that you or a
should be submitted to the docket for third party may not wish to be posted,
the document in which the substance is ACTION: Notice; request for comments.
such as medical information, your or
addressed. SUMMARY: The Food and Drug anyone else’s Social Security number, or
Please do not submit comments that Administration (FDA) is announcing its confidential business information, such
have already been submitted to other intent to exempt from the premarket as a manufacturing process. Please note
dockets. Such submissions are notification requirements autosomal that if you include your name, contact
tkelley on DSK3SPTVN1PROD with NOTICES
duplicative and not helpful to the recessive carrier screening gene information, or other information that
Agency. If comments on particular mutation detection systems, subject to identifies you in the body of your
documents or issues are submitted to certain limitations. These devices are comments, that information will be
this docket rather than the docket qualitative in vitro molecular diagnostic posted on http://www.regulations.gov.
specifically opened for the particular systems used for genotyping of • If you want to submit a comment
document or issue, the comment might clinically relevant variants in genomic with confidential information that you
not be considered as the specific deoxyribonucleic acid (DNA) isolated do not wish to be made available to the
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Document Created: 2015-12-14 15:36:15
Document Modified: 2015-12-14 15:36:15
| 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; establishment of public docket. | |
| Dates | Nominations and comments may be submitted to this docket at any time. | |
| Contact | Philantha Bowen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301- 796-2466. | |
| FR Citation | 80 FR 65770 |
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