80 FR 29717 - Pharmacy Compounding Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 99 (May 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 99 (May 22, 2015)
| Page Range | 29717-29719 | |
| FR Document | 2015-12512 |
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)] [Notices] [Pages 29717-29719] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12512] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Pharmacy Compounding Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pharmacy Compounding Advisory Committee. General Function of the Committee: To provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. Date and Time: The meeting will be held on June 17, 2015, from 8:30 a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/ [[Page 29718]] AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Jayne E. Peterson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847- 8533, email: PCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). The Drug Quality and Security Act adds a new section, 503B, to the FD&C Act (21 U.S.C. 353b) that creates a new category of ``outsourcing facilities.'' Outsourcing facilities, as defined in section 503B of the FD&C Act, are facilities that meet certain conditions described in section 503B, including registration with FDA as an outsourcing facility. If these conditions are satisfied, a drug product compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1), but not section 501(a)(2)(B). One of the conditions that must be satisfied to qualify for the exemptions under both sections 503A and 503B of the FD&C Act is that the drug that is compounded does not appear on a list published by the Secretary of drugs 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 (``withdrawn or removed list'') (see sections 503A(b)(1)(C) and 503B(a)(4) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list (``section 503A bulk drug substances list'') developed by the Secretary through regulations issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the compounded drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product (see section 503A(b)(3)(A) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act is that the compounded drug is not identified (directly or as part of a category of drugs) on a list published by the Secretary of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients, or the drug is compounded in accordance with all applicable conditions that are necessary to prevent the drug or category of drugs from presenting such demonstrable difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act). FDA will discuss with the committee drugs proposed for inclusion on the withdrawn or removed list pursuant to sections 503A and 503B and on the section 503A bulk drug substances list. FDA will also discuss with the committee the criteria FDA proposes to use to evaluate candidates to be identified as difficult to compound pursuant to sections 503A and 503B. Agenda: On June 17, 2015, during the morning session, the committee will receive updates on certain issues to follow up on discussions from the last meeting including the options for obtaining access to investigational new drugs and the processes FDA plans to use to add or remove drugs from the section 503A bulk drug substances list. During this session, the committee will also discuss revisions FDA is considering to the list of drug products that may not be compounded under the exemptions provided by the FD&C Act because the drug products 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. The list of those drug products is currently codified at 21 CFR 216.24. FDA now is considering whether to amend the rule to add four more drugs to the list: Aprotinin, ondansetron hydrochloride, bromocriptine mesylate, and acetaminophen. As previously explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 through 37690), the list may specify that a drug may not be compounded in any form, or, alternatively, may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list because an approved drug containing the same active ingredient(s) has not been withdrawn or removed from the market. Moreover, a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms because it has been found to be unsafe or not effective in those particular formulations, indications, routes of administration, or dosage forms. FDA plans to seek the committee's advice concerning the inclusion of these drug products. On June 17, 2015, during the afternoon session, the committee will discuss four bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: Brilliant Blue G, tranilast, N-acetyl-D-glucosamine, and oxitriptan. The nominators of these substances will be invited to make a short presentation supporting the nomination. Other nominated substances will be discussed at future committee meetings. During the morning session on June 18, 2015, the committee will discuss the criteria FDA is proposing to use to evaluate drug products or categories of [[Page 29719]] drug products for identification as demonstrably difficult to compound. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 9, 2015. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17, 2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18, 2015. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 4, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 8, 2015. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jayne E. Peterson at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 19, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-12512 Filed 5-21-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29717
Part 111 (21 CFR part 111) establishes test or examine 100 percent of the sets forth the information a
the minimum Current Good incoming dietary ingredients for manufacturer is required to submit in
Manufacturing Practice (CGMP) identity can be assured of the identity such a petition. The regulation also
necessary for activities related to of the ingredient. However, we contains a requirement to ensure that
manufacturing, packaging, labeling, or recognize that it may be possible for a the manufacturer keeps our response to
holding dietary supplements to ensure manufacturer to demonstrate, through a petition submitted under
the quality of the dietary supplement. various methods and processes in use § 111.75(a)(1)(ii) as a record under
Section 111.75(a)(1) (21 CFR over time for its particular operation, § 111.95. The collection of information
111.75(a)(1)) establishes a procedure for that a system of less than 100 percent in § 111.95 has been approved under
a petition to request an exemption from identity testing would result in no OMB control number 0910–0606.
100 percent identity testing of dietary material diminution of assurance of the Description of Respondents: The
ingredients. Under § 111.75(a)(1)(ii), identity of the dietary ingredient as respondents to this collection of
manufacturers may request an compared to the assurance provided by information are firms in the dietary
exemption from the requirements set 100 percent identity testing. To provide supplement industry, including dietary
forth in § 111.75(a)(1)(i) when the an opportunity for a manufacturer to supplement manufacturers, packagers
dietary ingredient is obtained from one make such a showing and reduce the and re-packagers, holders, labelers and
or more suppliers identified in the frequency of identity testing of re-labelers, distributors, warehouses,
petition. The regulation clarifies that we components that are dietary ingredients exporters, importers, large businesses,
are willing to consider, on a case-by- from 100 percent to some lower and small businesses.
case basis, a manufacturer’s conclusion, frequency, we added to § 111.75(a)(1) an
supported by appropriate data and exemption from the requirement of 100 In the Federal Register of March 9,
information in the petition submission, percent identity testing when a 2015 (80 FR 12491), FDA published a
that it has developed a system that it manufacturer petitions the Agency for 60-day notice requesting public
would implement as a sound, consistent such an exemption to 100 percent comment on the proposed collection of
means of establishing, with no material identity testing under § 10.30 (21 CFR information. One comment was
diminution of assurance compared to 10.30)and the Agency grants such received, but was not responsive to the
the assurance provided by 100 percent exemption. Such a procedure would be four collection of information topics
identity testing, the identity of the consistent with our stated goal, as solicited in the notice and, therefore, is
dietary ingredient before use. described in the CGMP final rule, of not discussed in this document.
Section 111.75(a)(1) reflects our providing flexibility in the CGMP We estimate the annual burden of this
determination that manufacturers that requirements. Section 111.75(a)(1)(ii) collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number Average
21 CFR section; CGMP requirements for dietary supple- Number of of responses Total annual burden per Total hours
ments respondents per responses response
respondent
111.75(a)(1)(ii) ..................................................................... 1 1 1 8 8
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, we have not Dated: May 18, 2015. General Function of the Committee:
received any new petitions to request an Leslie Kux, To provide advice on scientific,
exemption from 100 percent identity Associate Commissioner for Policy. technical, and medical issues
testing of dietary ingredients; therefore, [FR Doc. 2015–12398 Filed 5–21–15; 8:45 am] concerning drug compounding under
the Agency estimates that one or fewer BILLING CODE 4164–01–P sections 503A and 503B of the Federal
petitions will be submitted annually. Food, Drug, and Cosmetic Act (FD&C
Based on our experience with petition Act), and, as required, any other product
processes, we estimate it will take a DEPARTMENT OF HEALTH AND for which FDA has regulatory
requestor about 8 hours to prepare the HUMAN SERVICES responsibility, and make appropriate
factual and legal information necessary recommendations to the Commissioner
Food and Drug Administration
to support a petition for exemption and of Food and Drugs.
to prepare the petition. Although we [Docket No. FDA–2015–N–0001] Date and Time: The meeting will be
have not received any new petitions to held on June 17, 2015, from 8:30 a.m.
request an exemption from 100 percent Pharmacy Compounding Advisory
Committee; Notice of Meeting to 5 p.m., and on June 18, 2015, from
identity testing of dietary ingredients in 8:30 a.m. to 11:30 a.m.
the last 3 years, we believe that OMB AGENCY: Food and Drug Administration,
Location: FDA White Oak Campus,
approval of these information collection HHS.
10903 New Hampshire Ave., Bldg. 31,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
provisions should be extended to ACTION: Notice. Conference Center, the Great Room (Rm.
provide for the potential future need of
This notice announces a forthcoming 1503), Silver Spring, MD 20993–0002.
a firm in the dietary supplement
meeting of a public advisory committee Answers to commonly asked questions
industry to petition for an exemption
of the Food and Drug Administration including information regarding special
from 100 percent identity testing of
(FDA). The meeting will be open to the accommodations due to a disability,
dietary ingredients.
public. visitor parking, and transportation may
Name of Committee: Pharmacy be accessed at: http://www.fda.gov/
Compounding Advisory Committee. AdvisoryCommittees/
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![Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 29719
drug products for identification as ucm111462.htm for procedures on Dated: May 15, 2015.
demonstrably difficult to compound. public conduct during advisory Leslie Kux,
FDA intends to make background committee meetings. Associate Commissioner for Policy.
material available to the public no later Notice of this meeting is given under [FR Doc. 2015–12399 Filed 5–21–15; 8:45 am]
than 2 business days before the meeting. the Federal Advisory Committee Act (5 BILLING CODE 4164–01–P
If FDA is unable to post the background U.S.C. app. 2).
material on its Web site prior to the Dated: May 19, 2015.
meeting, the background material will DEPARTMENT OF HEALTH AND
Jill Hartzler Warner,
be made publicly available at the HUMAN SERVICES
location of the advisory committee Associate Commissioner for Special Medical
Programs.
meeting, and the background material Food and Drug Administration
will be posted on FDA’s Web site after [FR Doc. 2015–12512 Filed 5–21–15; 8:45 am]
[Docket No. FDA–2011–N–0781]
the meeting. Background material is BILLING CODE 4164–01–P
available at http://www.fda.gov/ Agency Information Collection
AdvisoryCommittees/Calendar/ Activities; Submission for Office of
default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
HUMAN SERVICES Management and Budget Review;
appropriate advisory committee meeting Comment Request; Record Retention
link. Requirements for the Soy Protein and
Procedure: Interested persons may Food and Drug Administration
Risk of Coronary Heart Disease Health
present data, information, or views, Claim
orally or in writing, on issues pending [Docket No. FDA–2014–N–0639]
before the committee. Written AGENCY: Food and Drug Administration,
Agency Information Collection HHS.
submissions may be made to the contact Activities; Announcement of Office of
person on or before June 9, 2015. Oral ACTION: Notice.
Management and Budget Approval;
presentations from the public will be
Requests for Inspection by an SUMMARY: The Food and Drug
scheduled between approximately 11
Accredited Person Under the Administration (FDA) is announcing
a.m. to 11:15 a.m. and 3:45 p.m. to 4
Inspection by Accredited Persons that a proposed collection of
p.m. on June 17, 2015, and between
Program information has been submitted to the
approximately 9:15 a.m. to 9:45 a.m. on
June 18, 2015. Those individuals Office of Management and Budget
AGENCY: Food and Drug Administration,
interested in making formal oral (OMB) for review and clearance under
HHS.
presentations should notify the contact the Paperwork Reduction Act of 1995.
ACTION: Notice. DATES: Fax written comments on the
person and submit a brief statement of
the general nature of the evidence or SUMMARY: The Food and Drug collection of information by June 22,
arguments they wish to present, the Administration (FDA) is announcing 2015.
names and addresses of proposed that a collection of information entitled ADDRESSES: To ensure that comments on
participants, and an indication of the ‘‘Requests for Inspection by an the information collection are received,
approximate time requested to make Accredited Person under the Inspection OMB recommends that written
their presentation on or before June 4, by Accredited Persons Program’’ has comments be faxed to the Office of
2015. Time allotted for each been approved by the Office of Information and Regulatory Affairs,
presentation may be limited. If the Management and Budget (OMB) under OMB, Attn: FDA Desk Officer, FAX:
number of registrants requesting to the Paperwork Reduction Act of 1995. 202–395–7285, or emailed to oira_
speak is greater than can be reasonably FOR FURTHER INFORMATION CONTACT: FDA submission@omb.eop.gov. All
accommodated during the scheduled PRA Staff, Office of Operations, Food comments should be identified with the
open public hearing session, FDA may and Drug Administration, 8455 OMB control number 0910–0428. Also
conduct a lottery to determine the Colesville Rd., COLE–14526, Silver include the FDA docket number found
speakers for the scheduled open public Spring, MD 20993–0002, PRAStaff@ in brackets in the heading of this
hearing session. The contact person will fda.hhs.gov. document.
notify interested persons regarding their FOR FURTHER INFORMATION CONTACT: FDA
request to speak by June 8, 2015. SUPPLEMENTARY INFORMATION: On
December 3, 2014, the Agency PRA Staff, Office of Operations, Food
Persons attending FDA’s advisory and Drug Administration, 8455
committee meetings are advised that the submitted a proposed collection of
information entitled ‘‘Requests for Colesville Rd.; COLE–14526, Silver
Agency is not responsible for providing Spring, MD 20993–0002 PRAStaff@
access to electrical outlets. Inspection by an Accredited Person
under the Inspection by Accredited fda.hhs.gov.
FDA welcomes the attendance of the
public at its advisory committee Persons Program’’ to OMB for review SUPPLEMENTARY INFORMATION: In
meetings and will make every effort to and clearance under 44 U.S.C. 3507. An compliance with 44 U.S.C. 3507, FDA
accommodate persons with physical Agency may not conduct or sponsor, has submitted the following proposed
disabilities or special needs. If you and a person is not required to respond collection of information to OMB for
require special accommodations due to to, a collection of information unless it review and clearance.
a disability, please contact Jayne E. displays a currently valid OMB control Record Retention Requirements for
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Peterson at least 7 days in advance of number. OMB has now approved the the Soy Protein and Risk of Coronary
the meeting. information collection and has assigned Heart Disease Health
FDA is committed to the orderly OMB control number 0910–0569. Claim—21 CFR 101.82(c)(2)(ii)(B)
conduct of its advisory committee The approval expires on April 30,
meetings. Please visit our Web site at 2018. A copy of the supporting OMB Control Number 0910–0428—
http://www.fda.gov/ statement for this information collection Extension
AdvisoryCommittees/ is available on the Internet at http:// Section 403(r)(3)(A) of the Federal
AboutAdvisoryCommittees/ www.reginfo.gov/public/do/PRAMain. Food, Drug, and Cosmetic Act (21 U.S.C.
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Document Created: 2015-12-15 15:44:51
Document Modified: 2015-12-15 15:44:51
| 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. | |
| FR Citation | 80 FR 29717 |
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