|CDER||February 23, 2015
February 24, 2015
|8:30 a.m. to 5:00 p.m.
8:15 a.m. to 3:00 p.m.
|FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
On February 23, 2015, during the morning session, the committee will discuss proposed revisions 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products that may not be compounded under the exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.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 products is currently codified at 216.24 (21 CFR 216.24), and FDA is proposing to revise and update the list at § 216.24 for purposes of both sections 503A and 503B of the FD&C Act. On July 2, 2014, FDA published a proposed rule that would add 25 drug products to this list and modify the description of one drug product on this list to add an exception (79 FR 37687, July 2, 2014). FDA received two drug-specific comments on the proposed rule. One comment requested that FDA clarify whether the entry for adenosine phosphate that is currently included on the list (all drug products containing adenosine phosphate) is intended to include all three forms of adenosine phosphate (mono-, di-, and triphosphate). The second comment requested that chloramphenicol tablets, 250 milligrams, be excluded from the list. FDA will discuss both of these comments with the committee.
On February 23, 2015, during the afternoon session, and on February 24, 2015, the committee will discuss proposed criteria for developing the list of bulk drug substances that may be used to compound drug products in accordance with section 503A of the FD&C Act and will discuss six substances nominated for inclusion on the list. On December 4, 2013, and July 2, 2014, FDA published notices in the Federal Register (78 FR 72841 and 79 FR 37747) soliciting nominations for this list. At this first meeting of the committee, FDA intends to discuss the following nominated bulk drug substances: Cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester, and thymol iodide. 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.
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.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees.
- Written submissions may be made to the contact person on or before February 9, 2015.
- Oral presentations from the public will be scheduled between approximately 10:15 a.m. to 10:45 a.m. and 3:35 p.m. to 3:50 p.m. on February 23, 2015 and between approximately 9:30 a.m. to 9:45 a.m. and 11:45 a.m. to 12:00 p.m. on February 24, 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 February 12, 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 February 13, 2015.
CDER plans to provide a free of charge, live webcast of the February 23-24, 2015 meeting of the Pharmacy Compounding Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2015 Meeting Materials, Pharmacy Compounding Advisory Committee.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- Jayne E. Peterson, B.S. Pharm., J.D.
Center for Drug Evalulation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Telephone: (301) 796-9001
Fax: (301) 847-8533
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting
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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
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 Peterson at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at: Public Conduct During FDA Advisory Committee Meetings 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).