503A Substances Approved or Denied Tracker - Updated November 2018
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1
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
of the Federal Food, Drug, and Cosmetic Act
503A Category 1 – Bulk Drug Substances Under Evaluation (if denied, will be illegal to compound)
2
PCAC Review DateApproved/DeniedNotesTotal Nominated326
3
7 Keto DehydroepiandrosteroneDenied30
4
Acetyl L Carnitine/Acetyl-L- carnitine
hydrochloride
DeniedApproved15
5
Acetyl-D-Glucosamine"Unsafe"4
Category 2
6
Alanyl-L-GlutamineDeniedNo Review267
Category 3
7
Aloe Vera/ Aloe Vera 200:1 Freeze DriedDenied% Approve5%
8
% Reject96%
9
Alpha Lipoic AcidNov-18ApprovedOral only, Denied for IVPending12
10
Artemisia/ArtemisininDeniedTotal to Review56
11
Astragalus Extract 10:1Total Reviewed45
12
BoswelliaDenied
Denied of reviewed
30
13
Brilliant Blue(not on April 2019 list)Approved
Approved of reviewed
15
14
Cantharidin(not on April 2019 list)Approved
% Approve:Reviewed
33%
15
Capsaicin palmitateThis was added after initial round
% Denied:Reviewed
67%
16
Choline Chloride
17
Chondroitin SulfateDenied
18
ChrysinDenied
19
Coenzyme Q10










?Nov-18Approved
20
• Creatine MonohydrateNov-18Approved
21
• CurcuminDenied
22
• Deoxy-D-GlucoseDenied
23
• DichloroacetateDenied
24
• DiindolylmethaneDenied
25
• Dimercapto-1- propanesulfonic acid (DMPS)Approved
26
• Diphenylcyclopropenone (DPCP)(not on April 2019 list)Approvedfor topical use only
27
• EGCgDenied
28
• Ferric Subsulfate
29
• GlutaraldehydeApprovedFor topical
30
• Glutathione
31
• Glycolic AcidApprovedFor topical
32
• GlycyrrhizinDeniedLicorice extract
33
• Kojic AcidDenied
34
• L-Citrulline
35
Melatonin
36
Methylcobalamin
37
Methylsulfonylmethane (MSM)Denied
38
Nettle leaf (Urtica dioica subsp. dioica leaf)Denied
39
Nicotinamide Adenine Dinucleotide (NAD)Denied
40
Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)Denied
41
• OxitriptanDeniedMigraine sufferers
42
• PiracetamDenied
43
• Pregnenolone
44
• Pyridoxal 5-Phosphate MonohydrateNov-18Approved
45
• Pyruvic AcidApprovedFor topical
46
• Quercetin/Quercetin DihydrateNov-18Denied
47
• Quinacrine Hydrochloride (except for intrauterine administration)DeniedMoved to Category 2
48
• ResveratrolDenied
49
• Ribose (D)Denied
50
• Rubidium ChlorideDenied
51
• Silver Protein MildDenied
52
• Squaric Acid Dibutyl Ester (aka dibutyl squarate)(not on April 2019 list)ApprovedFor topical
53
• Tea tree oil (Melaleuca alternifolia leaf oil)Approved
54
• Thymol Iodide(not on April 2019 list)ApprovedFor topical
55
• TranilastDenied
56
• Trichloroacetic AcidApprovedFor topical
57
• Ubiquinol 30% PowderDeniedActivated version of CoQ10
58
• VanadiumDenied
59
• Vasoactive Intestinal PeptideDeniedChronic mold toxicity
60
61
1
62
503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks (automatically illegal to compound)
63
Cesium Chloride
Domperidone
64
Quinacrine Hydrochloride for
intrauterine administration
65
Germanium Sesquioxide
66
2
67
503A Category 3: Bulk Drug Substances Nominated Without Adequate Support (Will be illegal to compound if FDA is not stopped, and FDA will not even review)
68
Acetanilide
Adenosine-5-triphosphate disodium salt
69
Alcloxa
70
Aldioxa
71
Aldosterone
72
Alfalfa
73
Alfalfa leaves
74
Almadrate sulfate
75
Aloin
76
Alpha Ketoglutaric acid
77
Alumina Powder, hydrated
78
Aluminum phosphate
79
Aminacrine Hydrochloride
80
Ammonium bromide
81
Ammonium hydroxide
82
Anise seed
83
Argentyn
84
Aromatic powder
85
Asafetida
86
Asclepias tuberosa
Asefetida Tincture
87
Asparagus
88
Aspergillus oryza enzymes
89
Barosma
90
Beechwood creosote
91
Bean
92
Betamechlomathasone
93
Beta-Nicotinamide Adenine Dinucleotide
94
Disodium Salt Trihydrate
Bichloroacetic Acid
95
Calcium Folinate
Calcium Glycinate
96
Carbazochrome
97
Carbimazole
98
Cedarwood Essential Oil
Chlorhexidine Diacetate Hydrate
99
Choline bitartrate
100
Choline magnesium trisalicylate
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