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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 9/12/18-9/12/18

Meeting Details:

The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. Drug - > Uses Reviewed - >(alpha lipoic acid) Diabetic neuropathy and associated pain, acute liver toxicity from Amanitaspp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain (coenzyme Q10) Mitochondrial disorders (creatine monohydrate) Mitochondrial disorders (pyridoxal 5 phosphate) Epilepsy and seizure disorders (choline chloride) Hepatic steatosis, supplementation in long term total parenteral nutrition, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis (quercetin dihydrate) Asthma, allergy, cancer prevention and treatment, and hypertension

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 5/8/17-5/9/17

Meeting Details:

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding Advisory Committee

Meeting Date: 6/23/16-6/23/16

Meeting Details:

The committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 3/8/16-3/9/16

Meeting Details:

On March 8, 2016, the committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA will discuss the following nominated bulk drug substances: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators of these substances will be invited to make a short presentation supporting the nomination. On March 9, 2016, the committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding. These categories of drug products are metered dose inhalers and dry powder inhalers. The nominators who nominated the category of drugs or specific drug products in the category will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 7/13/00-7/14/00

Meeting Details:

On July 13, 2000, the committee will review five drug products for inclusion on a list of drug products that cannot be compounded because they 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 whereby FDA amended its regulations to include such a list of drug products). In the Federal Register of January 4, 2000 (65 FR 256), FDA published a proposed rule amending these regulations to add two drug products to the list: (1) Aminopyrine (all drug products containing aminopyrine) and (2) astemizole (all drug products containing astemizole). In addition to these two drug products, the committee will review the following three drug products: (1) Grepafloxacin (all drug products containing grepafloxacin), (2) troglitazone (all drug products containing troglitazone), and (3) cisapride (all drug products containing cisapride). Beginning at approximately 10 a.m., and continuing on July 14, 2000, at approximately 8:30 a.m., the committee will discuss and provide FDA with advice about drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of those drug products.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 5/6/99-5/7/99

Meeting Details:

The committee will discuss and provide FDA with advice about the agency's development and publication of a list of bulk drug substances that may be used in pharmacy compounding that do not have a United States Pharmacopeia or National Formulary monograph and are not components of FDA-approved drugs. Specifically, the committee is likely to address the following drug substances as candidates for the bulk drugs list: 4-aminopyridine, 3,4-diaminopyridine, betahistine dihydrochloride, chloramine-T, cyclandelate, dinitrochlorobenzene, diphenylcyclopropenone, hydrazine sulfate, mild silver protein, monosodium asparate, pentylenetetrazole, peruvian balsam, and squaric acid dibutyl ester.

 

       
Location: CDER Advisory Committee Conference Room 1066 56 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding

Meeting Date: 10/14/98-10/16/98

Meeting Details:

The Committee will address those bulk drug substances that are neither components of FDA approved products nor covered by a USP monograph for inclusion on a list of bulk drug substances that may be used in compounding that qualifies for the applicable statutory exemptions. The Committee will also review drug products to be included on a list which have been withdrawn or removed from the market for reasons of safety or efficacy which may not be used in compounding that qualifies for the applicable statutory exemptions.

 

       
Location: Food and Drug Administration Building Rockville, Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 5/15/20-5/15/20

Meeting Details:

The Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies Advisory Committee

Meeting Date: 5/8/20-5/8/20

Meeting Details:

On May 8, 2020, the committee will meet by teleconference. In open session, the committee will hear an overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.

 

       
Location: VIRTUAL Related News Links: Not Available
Time: 1:00AM-4:55AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/29/20-4/29/20

Meeting Details:

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Location: tbd Related News Links: Not Available
Time: 9:00AM-5:00PM    
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