80 FR 28622 - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 96 (May 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 96 (May 19, 2015)
| Page Range | 28622-28624 | |
| FR Document | 2015-11983 |
[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)] [Notices] [Pages 28622-28624] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11983] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1196] List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for nominations. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) intends to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' You may nominate specific bulk drug substances for this list. This notice describes the information that should be provided to the Agency in support of each nomination. DATES: To ensure that FDA considers your nominations for the initial version of the bulk drug substances list, submit either electronic or written nominations for the bulk drug substances list by August 17, 2015. After the comment period is closed, nominations to add or remove bulk drug substances from the list may be submitted to FDA by citizen petition under Sec. 10.30 (21 CFR 10.30). ADDRESSES: You may submit nominations by any of the following methods. Electronic Submissions Submit electronic nominations in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written nominations in the following ways: Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA-2013-N-1524. All nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting nominations, see the ``Request for Nominations'' heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or nominations 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: Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., Rockville, MD 20855, 240-402-5745, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the FD&C Act do not apply to the compounding of animal drugs. The FD&C Act does not distinguish between compounding animal drugs from bulk drug substances \1\ and any other manufacturing or processing of animal drugs. Except with respect to the limited exemption provided by the FD&C Act described in this document, statutory provisions applicable to manufactured animal drugs under the FD&C Act also apply to compounded animal drugs. --------------------------------------------------------------------------- \1\ FDA regulations define ``bulk drug substance'' as ``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.'' 21 CFR 207.3(a)(4). ``Active ingredient'' is defined as ``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.'' 21 CFR 210.3(b)(7). Any component other than an active ingredient is an ``inactive ingredient.'' See 21 CFR 210.3(b)(8). Inactive ingredients used in compounded drug products commonly include flavorings, dyes, diluents, or other excipients. --------------------------------------------------------------------------- Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)) provide a limited exemption from certain requirements for use for compounded animal drugs made from already approved animal or human drugs. Such use is considered an extra-label use and the FD&C Act provides that a compounded drug is exempt from the approval requirements and requirements of section 502(f)(1) (21 U.S.C. 352(f)(1)) of the FD&C Act, if it meets the conditions set out in the statute and the extra-label use regulations at 21 CFR part 530. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances'' (GFI #230).\2\ The draft guidance describes conditions under which FDA does not generally intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under section 503B of the FD&C Act (outsourcing facilities) that compound animal drugs from bulk drug substances. --------------------------------------------------------------------------- \2\ GFI #230 can be found at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm. --------------------------------------------------------------------------- For pharmacies, these conditions include receipt of a valid prescription for a compounded drug from a licensed veterinarian for an individually identified animal patient before the [[Page 28623]] facility compounds the drug (with some limited compounding of an animal drug product in advance of receipt of a prescription in quantities based on a history of receipt of patient-specific prescriptions for that drug product). FDA recognizes that there may be some limited circumstances in which a drug compounded from one or more bulk drug substances should be available to a veterinarian for office use and is developing a list of such animal drug products and the bulk drug substances needed to make them applicable to drugs compounded by facilities registered as outsourcing facilities under section 503B of the FD&C Act. The draft guidance proposes that outsourcing facilities compound animal drugs only from bulk drug substances that will be listed in Appendix A of the final guidance, either pursuant to a veterinarian's order or pursuant to a patient-specific prescription. When a facility registered as an outsourcing facility under section 503B of the FD&C Act uses the listed bulk drug substances to make the specified drug products pursuant to an order from a licensed veterinarian without a prescription for an individually identified animal, FDA does not intend to take action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)), 502(f), and 501(a)(2)(B) as long as such compounding is done in accordance with any associated conditions described in GFI #230. Although an outsourcing facility may fill a veterinarian's order for compounded animal drugs using bulk drug substances listed on Appendix A without obtaining prescriptions for individually identified animal patients, drugs produced by outsourcing facilities remain subject to the requirements in section 503(f) of the FD&C Act. Therefore, an outsourcing facility cannot dispense a compounded drug to the owner or caretaker of an animal patient without a prescription for that individually identified animal patient. This list only applies to outsourcing facilities. This list does not limit what bulk drug substances State-licensed pharmacies or licensed veterinarians can use in compounding drugs in accordance with the conditions set forth in the draft guidance, including the condition pertaining to obtaining a patient-specific prescription. FDA intends to include a bulk drug substance on Appendix A only when all of the following criteria are met: There is no marketed approved, conditionally approved, or index-listed animal drug that can be used as labeled to treat the condition; there is no marketed approved animal or human drug that could be used under section 512(a)(4) or (a)(5) of the FD&C Act and part 530 (addressing extra-label use of approved animal and human drugs) to treat the condition; the drug cannot be compounded from an approved animal or human drug; immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and FDA has not identified a significant safety concern specific to the use of the bulk drug substance to compound animal drugs (under the listed conditions and limitations). Inactive ingredients need not appear on Appendix A to be used in compounding animal drug products. II. Request for Nominations A. Active Ingredients You may nominate specific bulk drug substances for inclusion on the list in Appendix A. Nominations will only be evaluated if they are for specific ingredients that meet the definition of a bulk drug substance in Sec. 207.3(a)(4) (21 CFR 207.3(a)(4)). Nominated substances that do not meet this definition will not be included on the list. To determine if a bulk drug substance should be included in Appendix A, FDA needs the following information about the bulk drug substance being nominated and the animal drug product(s) that will be compounded using such substance: 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 the identified compounded drug product(s), citing to 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 used in the FDA/U.S. Pharmacopeial Convention (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; 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. Information on the Animal Drug Products 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 product(s); and information about the anticipated route(s) of administration of the compounded product(s). C. Need for the Animal Drug Products That Will Be Compounded With the Bulk Drug Substance For FDA to be able to meaningfully evaluate a substance, the information provided must be specific to the particular substance nominated and animal drug product to be compounded. A ``boilerplate'' or general explanation of need for compounding with bulk drug substances will not enable FDA to conduct an adequate review. Unless adequate supporting data are submitted for a bulk drug substance, FDA will be unable to consider it for inclusion in Appendix A. Prescribers of compounded animal drug products may be in the best position to explain why a particular bulk drug substance meets the criteria for including a bulk drug substance on Appendix A and are encouraged to provide data in support of a nomination. The following information about need is necessary to provide adequate support for nominations to the Appendix A list: A statement identifying the species and condition(s) that the drug product to be compounded with the nominated bulk drug substance is intended to treat; a bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available,\3\ including any relevant peer-reviewed veterinary literature; --------------------------------------------------------------------------- \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 animal drug application. --------------------------------------------------------------------------- a list of animal drug products, if any, that are approved, conditionally approved, or index listed for the [[Page 28624]] condition(s) in the species that the drug compounded with the nominated substance is intended to address; if there are FDA-approved or index listed drug products that address the same conditions in the same species, an explanation, supported by relevant veterinary literature, of why a compounded drug product is necessary (i.e., why the approved drug product is not suitable for a particular patient population); a review of the veterinary literature to determine whether there are FDA-approved animal or human drugs that could be prescribed as an extra-label use under section 512(a)(4) and (a)(5) of the FD&C Act and part 530 to treat the condition(s) in the species that the drug compounded with the nominated substance is intended to address; if the bulk drug substance is an active ingredient in an approved animal or human drug, an explanation, supported by appropriate scientific data, of why the animal drug product cannot be compounded from the approved drug under 21 CFR 530.13(b); an explanation, supported by relevant veterinary literature, of why the animal drug product to be compounded with the nominated bulk drug substance must be available to the veterinarian for immediate treatment to avoid animal suffering or death. Nominations should include specific information documenting that animal suffering or death will result if treatment is delayed until a compounded animal drug can be obtained pursuant to a prescription for an individually identified animal; and a discussion of any safety concerns associated with use of the nominated bulk drug substance or finished compounded product for the condition(s) in the species that the compounded drug is intended to address. If there are any safety concerns, an explanation, supported by veterinary literature, of why the concerns should not preclude inclusion of that bulk drug substance on Appendix A. D. Nomination Process For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in a format that explicitly addresses each item previously listed in the order that they appear. To consider a bulk drug substance for inclusion in Appendix A, FDA must receive adequate supporting data for the substance. FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on Appendix A prior to its initial publication. Nominations that are not evaluated during this first phase will receive consideration for later addition to Appendix A. Individuals and organization may petition FDA to make additional amendments to Appendix A after it is published, in accordance with Sec. 10.30. Interested persons may submit either electronic nominations to http://www.regulations.gov or written nominations to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of nominations. Identify nominations with the docket number found in the brackets in the heading of this document. Received nominations may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11983 Filed 5-18-15; 8:45 am] BILLING CODE 4164-01-P
![28622 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices
drugs (e.g., OxyContin) and illicit opioid specific bulk drug substances for this animal drugs. The FD&C Act does not
drugs (e.g., heroin). It is currently the list. This notice describes the distinguish between compounding
standard treatment for those information that should be provided to animal drugs from bulk drug
experiencing overdose and is commonly the Agency in support of each substances 1 and any other
used by trained medical personnel in nomination. manufacturing or processing of animal
emergency departments and on DATES: To ensure that FDA considers drugs. Except with respect to the limited
ambulances. Its use among nonmedical your nominations for the initial version exemption provided by the FD&C Act
personnel has also increased in recent of the bulk drug substances list, submit described in this document, statutory
years. The purpose of the public either electronic or written nominations provisions applicable to manufactured
meeting is to explore issues surrounding for the bulk drug substances list by animal drugs under the FD&C Act also
the uptake of naloxone to treat opioid August 17, 2015. apply to compounded animal drugs.
drug overdose. The meeting agenda will After the comment period is closed, Section 512(a)(4) and (5) of the FD&C
include topics on the clinical, nominations to add or remove bulk drug Act (21 U.S.C. 360b(a)(4) and (5))
regulatory, and legal implications of substances from the list may be provide a limited exemption from
making naloxone more widely available. submitted to FDA by citizen petition certain requirements for use for
FDA will post the agenda and additional compounded animal drugs made from
under § 10.30 (21 CFR 10.30).
public meeting material approximately already approved animal or human
ADDRESSES: You may submit
2 days before the workshop at: http:// drugs. Such use is considered an extra-
nominations by any of the following label use and the FD&C Act provides
www.fda.gov/Drugs/NewsEvents/
methods. that a compounded drug is exempt from
ucm442236.htm.
Electronic Submissions the approval requirements and
II. Transcripts requirements of section 502(f)(1) (21
A transcript will be made available Submit electronic nominations in the
U.S.C. 352(f)(1)) of the FD&C Act, if it
approximately 45 days after the public following way:
• Federal eRulemaking Portal: http:// meets the conditions set out in the
meeting. It will be accessible at http:// statute and the extra-label use
www.regulations.gov. Follow the
www.regulations.gov and may be regulations at 21 CFR part 530.
instructions for submitting comments.
viewed at the Division of Dockets Elsewhere in this issue of the Federal
Management (see Comments). A Written Submissions Register, FDA is announcing the
transcript will also be available in either Submit written nominations in the availability of a draft guidance for
hardcopy or on CD–ROM, after following ways: industry #230 entitled ‘‘Compounding
submission of a Freedom of Information • Mail/Hand delivery/Courier (for Animal Drugs from Bulk Drug
request. Written requests are to be sent paper submissions): Division of Dockets Substances’’ (GFI #230).2 The draft
to Division of Freedom of Information Management (HFA–305), Food and Drug guidance describes conditions under
(ELEM–1029), Food and Drug Administration, 5630 Fishers Lane, rm. which FDA does not generally intend to
Administration, 12420 Parklawn Dr., 1061, Rockville, MD 20852. initiate enforcement action against
Element Bldg., Rockville, MD 20857. State-licensed pharmacies, licensed
Instructions: All submissions received
Dated: May 13, 2015. veterinarians, and facilities registered as
must include the Docket No. FDA–
Leslie Kux, outsourcing facilities under section
2013–N–1524. All nominations received
503B of the FD&C Act (outsourcing
Associate Commissioner for Policy. may be posted without change to http://
facilities) that compound animal drugs
[FR Doc. 2015–12061 Filed 5–18–15; 8:45 am] www.regulations.gov, including any
from bulk drug substances.
BILLING CODE 4164–01–P personal information provided. For For pharmacies, these conditions
additional information on submitting include receipt of a valid prescription
nominations, see the ‘‘Request for for a compounded drug from a licensed
DEPARTMENT OF HEALTH AND Nominations’’ heading of the veterinarian for an individually
HUMAN SERVICES SUPPLEMENTARY INFORMATION section of identified animal patient before the
this document.
Food and Drug Administration Docket: For access to the docket to 1 FDA regulations define ‘‘bulk drug substance’’
[Docket No. FDA–2015–N–1196] read background documents or as ‘‘any substance that is represented for use in a
nominations received, go to http:// drug and that, when used in the manufacturing,
List of Bulk Drug Substances That May www.regulations.gov and insert the processing, or packaging of a drug, becomes an
active ingredient or a finished dosage form of the
Be Used by an Outsourcing Facility To docket number, found in brackets in the drug, but the term does not include intermediates
Compound Drugs for Use in Animals; heading of this document, into the used in the synthesis of such substances.’’ 21 CFR
Request for Nominations ‘‘Search’’ box and follow the prompts 207.3(a)(4). ‘‘Active ingredient’’ is defined as ‘‘any
and/or go to the Division of Dockets component that is intended to furnish
AGENCY: Food and Drug Administration, pharmacological activity or other direct effect in the
Management, 5630 Fishers Lane, rm. diagnosis, cure, mitigation, treatment, or prevention
HHS.
1061, Rockville, MD 20852. of disease, or to affect the structure or any function
ACTION: Notice; request for nominations.
FOR FURTHER INFORMATION CONTACT: Neal of the body of man or other animals. The term
Bataller, Center for Veterinary Medicine, includes those components that may undergo
SUMMARY: The Food and Drug chemical change in the manufacture of the drug
Administration (FDA) intends to Food and Drug Administration (HFV– product and be present in the drug product in a
develop a list of bulk drug substances 210), 7519 Standish Pl., Rockville, MD modified form intended to furnish the specified
that may be used by outsourcing 20855, 240–402–5745, neal.bataller@ activity or effect.’’ 21 CFR 210.3(b)(7). Any
component other than an active ingredient is an
tkelley on DSK3SPTVN1PROD with NOTICES
facilities registered under the Federal fda.hhs.gov.
‘‘inactive ingredient.’’ See 21 CFR 210.3(b)(8).
Food, Drug, and Cosmetic Act (the SUPPLEMENTARY INFORMATION: Inactive ingredients used in compounded drug
FD&C Act) to compound animal drugs, products commonly include flavorings, dyes,
in accordance with FDA’s draft I. Background diluents, or other excipients.
2 GFI #230 can be found at http://www.fda.gov/
guidance for industry #230, Sections 503A (21 U.S.C. 353a) and AnimalVeterinary/
‘‘Compounding Animal Drugs from Bulk 503B (21 U.S.C. 353b) of the FD&C Act GuidanceComplianceEnforcement/
Drug Substances.’’ You may nominate do not apply to the compounding of GuidanceforIndustry/ucm042450.htm.
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![28624 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices
condition(s) in the species that the drug will receive consideration for later 10.115(g)(5)), to ensure that FDA
compounded with the nominated addition to Appendix A. considers your comment on the draft
substance is intended to address; Individuals and organization may guidance before it begins work on the
• if there are FDA-approved or index petition FDA to make additional final version of the guidance, submit
listed drug products that address the amendments to Appendix A after it is either electronic or written comments
same conditions in the same species, an published, in accordance with § 10.30. on the draft guidance by August 17,
explanation, supported by relevant Interested persons may submit either 2015. Submit written or electronic
veterinary literature, of why a electronic nominations to http:// comments on the proposed collection of
compounded drug product is necessary www.regulations.gov or written information by August 17, 2015.
(i.e., why the approved drug product is nominations to the Division of Dockets ADDRESSES: Submit written requests for
not suitable for a particular patient Management (see ADDRESSES). It is only single copies of the draft guidance to the
population); necessary to send one set of Policy and Regulations Staff (HFV–6),
• a review of the veterinary literature nominations. Identify nominations with Center for Veterinary Medicine, Food
to determine whether there are FDA- the docket number found in the brackets and Drug Administration, 7519 Standish
approved animal or human drugs that in the heading of this document. Pl., Rockville, MD 20855. Send one self-
could be prescribed as an extra-label use Received nominations may be seen in addressed adhesive label to assist that
under section 512(a)(4) and (a)(5) of the the Division of Dockets Management office in processing your request. See
FD&C Act and part 530 to treat the between 9 a.m. and 4 p.m., Monday the SUPPLEMENTARY INFORMATION section
condition(s) in the species that the drug through Friday, and will be posted to for electronic access to the draft
compounded with the nominated the docket at http:// guidance.
substance is intended to address; www.regulations.gov. Submit electronic comments on the
• if the bulk drug substance is an Dated: May 12, 2015. draft guidance, including comments
active ingredient in an approved animal regarding the proposed collection of
Leslie Kux,
or human drug, an explanation, information, to http://
Associate Commissioner for Policy.
supported by appropriate scientific data, www.regulations.gov. Submit written
[FR Doc. 2015–11983 Filed 5–18–15; 8:45 am]
of why the animal drug product cannot comments on the draft guidance,
be compounded from the approved drug BILLING CODE 4164–01–P
including comments regarding the
under 21 CFR 530.13(b); proposed collection of information, to
• an explanation, supported by
DEPARTMENT OF HEALTH AND the Division of Dockets Management
relevant veterinary literature, of why the
HUMAN SERVICES (HFA–305), Food and Drug
animal drug product to be compounded
Administration, 5630 Fishers Lane, Rm.
with the nominated bulk drug substance Food and Drug Administration 1061, Rockville, MD 20852.
must be available to the veterinarian for
[Docket Nos. FDA–2015–D–1176 and FDA– FOR FURTHER INFORMATION CONTACT:
immediate treatment to avoid animal
suffering or death. Nominations should 2003–D–0202] With regard to this draft guidance:
include specific information Division of Compliance, Center for
Compounding Animal Drugs From Veterinary Medicine, Food and Drug
documenting that animal suffering or
Bulk Drug Substances; Draft Guidance Administration (HFV–230), 7519
death will result if treatment is delayed
for Industry; Availability; Withdrawal of Standish Pl., Rockville, MD 20855, 240–
until a compounded animal drug can be
Compliance Policy Guide; Section 402–7001, CVMCompliance@
obtained pursuant to a prescription for 608.400 Compounding of Drugs for
an individually identified animal; and fda.hhs.gov.
Use in Animals With regard to the proposed collection
• a discussion of any safety concerns
associated with use of the nominated of information: FDA PRA Staff, Office of
AGENCY: Food and Drug Administration,
bulk drug substance or finished HHS. Operations, Food and Drug
compounded product for the Administration, 8455 Colesville Rd.;
ACTION: Notice; withdrawal. COLE–14526, Silver Spring, MD 20993–
condition(s) in the species that the
compounded drug is intended to SUMMARY: The Food and Drug 0002; PRAStaff@fda.hhs.gov.
address. If there are any safety concerns, Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION:
an explanation, supported by veterinary availability of a draft guidance for I. Draft Guidance
literature, of why the concerns should industry (GFI) #230 entitled
‘‘Compounding Animal Drugs from Bulk FDA is announcing the availability of
not preclude inclusion of that bulk drug
Drug Substances.’’ The draft guidance a draft GFI #230 entitled ‘‘Compounding
substance on Appendix A.
describes FDA’s policies with regard to Animal Drugs from Bulk Drug
D. Nomination Process compounding animal drugs from bulk Substances.’’ The draft guidance
For efficient consolidation and review drug substances. When final, the provides information to compounders of
of nominations, nominators are guidance will reflect FDA’s current animal drugs and other interested
encouraged to submit their nominations thinking on the issues addressed by the stakeholders on FDA’s application of
in a format that explicitly addresses guidance. the Federal Food, Drug, and Cosmetic
each item previously listed in the order FDA is also announcing the Act (the FD&C Act) with respect to the
that they appear. To consider a bulk withdrawal of the compliance policy compounding of animal drugs from bulk
drug substance for inclusion in guide (CPG) entitled ‘‘Section 608.400 drug substances.1
Appendix A, FDA must receive Compounding of Drugs for Use in
1 FDA regulations define ‘‘bulk drug substance’’
tkelley on DSK3SPTVN1PROD with NOTICES
adequate supporting data for the Animals,’’ which was issued in July
as ‘‘any substance that is represented for use in a
substance. FDA cannot guarantee that 2003. This 2003 CPG is being drug and that, when used in the manufacturing,
all drugs nominated during the withdrawn because it is no longer processing, or packaging of a drug, becomes an
nomination period will be considered consistent with FDA’s current thinking active ingredient or a finished dosage form of the
on the issues it addresses. drug, but the term does not include intermediates
for inclusion on Appendix A prior to its used in the synthesis of such substances.’’ 21 CFR
initial publication. Nominations that are DATES: Although you can comment on 207.3(a)(4). ‘‘Active ingredient’’ is defined as ‘‘any
not evaluated during this first phase any guidance at any time (see 21 CFR component that is intended to furnish
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Document Created: 2015-12-15 15:29:26
Document Modified: 2015-12-15 15:29:26
| 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; request for nominations. | |
| Dates | To ensure that FDA considers your nominations for the initial version of the bulk drug substances list, submit either electronic or written nominations for the bulk drug substances list by August 17, 2015. | |
| Contact | Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., Rockville, MD 20855, 240-402-5745, [email protected] | |
| FR Citation | 80 FR 28622 |
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