503A Substances Approved or Denied Tracker - Updated November 2018

	A	B	C	D	E	G	H	I
1	3Bulk 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) . HIGHLIGHTED SUBSTANCES STILL PENDING REVIEW
2			PCAC Review Date	Approved/Denied	Notes	Total Nominated	326
3	• 7 Keto Dehydroepiandrosterone			Denied		Denied	34
4	• Acetyl L Carnitine/Acetyl-L- carnitine hydrochloride			Denied		Approved	18
5	• Acetyl-D-Glucosamine					"Unsafe"	4	Category 2
6	• Alanyl-L-Glutamine			Denied		No Review	267	Category 3
7	• Aloe Vera/ Aloe Vera 200:1 Freeze Dried			Denied		% Approve	6%
8						% Reject	98%
9	• Alpha Lipoic Acid		11/1/2018	Approved	Oral only, Denied for IV	Pending	6
10	• Artemisia/Artemisinin			Denied		Total to Review	56
11	• Astragalus Extract 10:1			Denied		Total Reviewed	49
12	• Boswellia			Denied		Denied of reviewed	34
13	• Brilliant Blue	(not on April 2019 list)		Approved		Approved of reviewed	15
14	• Cantharidin	(not on April 2019 list)		Approved		% Approve:Reviewed	31%
15	• Capsaicin palmitate	This was added after initial round				% Denied:Reviewed	69%
16	• Choline Chloride		6/9/2021	Denied
17	• Chondroitin Sulfate			Denied
18	• Chrysin			Denied
19	• Coenzyme Q10	?	11/1/2018	Approved
20	• Creatine Monohydrate		11/1/2018	Approved
21	• Curcumin			Denied
22	• D-ribose			Denied
23	• Deoxy-D-Glucose			Denied
24	• Dichloroacetate			Denied
25	• Diindolylmethane			Denied
26	• Dimercapto-1- propanesulfonic acid (DMPS)			Approved
27	• Diphenylcyclopropenone (DPCP)	(not on April 2019 list)		Approved	for topical use only
28	• EGCg			Denied
29	• Ferric Subsulfate		6/8/2022
30	• Glutaraldehyde			Approved	For topical
31	• Glutathione		6/8/2022
32	• Glycolic Acid			Approved	For topical
33	• Glycyrrhizin			Denied	Licorice extract
34	• Kojic Acid			Denied
35	• L-Citrulline			Approved
36	• Melatonin		6/9/2021	Approved
37	• Methylcobalamin		6/9/2021	Approved
38	• Methylsulfonylmethane (MSM)			Denied
39	• Nettle leaf (Urtica dioica subsp. dioica leaf)			Denied
40	• Nicotinamide Adenine Dinucleotide (NAD)			Denied
41	• Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)			Denied
42	• Oxitriptan	Both denied for some conditions, and approved for others		Denied	Migraine sufferers (but approved for tetrahydrobiopterin (BH4) deficiency)
43	• Piracetam			Denied
44	• Pregnenolone
45	• Pyridoxal 5-Phosphate Monohydrate		11/1/2018	Approved
46	• Pyruvic Acid			Approved	For topical
47	• Quercetin/Quercetin Dihydrate		11/1/2018	Denied
48	• Quinacrine Hydrochloride (except for intrauterine administration)			Denied	Moved to Category 2
49	• Resveratrol			Denied
50	• Ribose (D)			Denied
51	• Rubidium Chloride			Denied
52	• Silver Protein Mild			Denied
53	• Squaric Acid Dibutyl Ester (aka dibutyl squarate)	(not on April 2019 list)		Approved	For topical
54	• Tea tree oil (Melaleuca alternifolia leaf oil)			Approved
55	• Thymol Iodide	(not on April 2019 list)		Approved	For topical
56	• Tranilast			Denied
57	• Trichloroacetic Acid			Approved	For topical
58	• Ubiquinol 30% Powder			Denied	Activated version of CoQ10
59	• Vanadium			Denied
60	• Vasoactive Intestinal Peptide			Denied	Chronic mold toxicity
61
62	1
63	503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks (automatically illegal to compound)
64	• Cesium Chloride • Domperidone
65	• Quinacrine Hydrochloride for intrauterine administration
66	• Germanium Sesquioxide
67	2
68	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)
69	• Acetanilide • Adenosine-5-triphosphate disodium salt
70	• Alcloxa
71	• Aldioxa
72	• Aldosterone
73	• Alfalfa
74	• Alfalfa leaves
75	• Almadrate sulfate
76	• Aloin
77	• Alpha Ketoglutaric acid
78	• Alumina Powder, hydrated
79	• Aluminum phosphate
80	• Aminacrine Hydrochloride
81	• Ammonium bromide
82	• Ammonium hydroxide
83	• Anise seed
84	• Argentyn
85	• Aromatic powder
86	• Asafetida
87	• Asclepias tuberosa • Asefetida Tincture
88	• Asparagus
89	• Aspergillus oryza enzymes
90	• Barosma
91	• Beechwood creosote
92	• Bean
93	• Betamechlomathasone
94	• Beta-Nicotinamide Adenine Dinucleotide
95	Disodium Salt Trihydrate • Bichloroacetic Acid
96	• Calcium Folinate • Calcium Glycinate
97	• Carbazochrome
98	• Carbimazole
99	• Cedarwood Essential Oil • Chlorhexidine Diacetate Hydrate
100	• Choline bitartrate