FDA Warning Letters to
Compounding Pharmacies and Suppliers
The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment. Most sellers do what FDA requests. This page indexes warning letters sent to compounding pharmacies and supllier that have prepared or distributed prescription drugs or other drug products that lack FDA approval.
- American Hormones, Inc. / Govind Gil (1/10/08): Testosterone lipoderm gel, thyroid (T4/T3) capsules, pregnenolone capsules, DHEA (dehydroepiandrosterone) capsules, and human growth hormone products
- Axium Healthcare Pharmacy / James Peter Sumerville (6/7/04): domperidone, ribavirin
- Bellevue Pharmacy Solutions / Paul Huesemen (1/14/08): Compounded hyaluronidase, progesterone, diphenhydramine, dimenhydrinate, folic acid, pyridoxine, thiamine, and EDTA (edetate disodium)
- Cape Drugs / Tom Wilson (7/11/05): domperidone
- Civic Center Pharmacy / Ari S. Schafer (12/16/08): Estriol (Bioidentical hormones)
- College Pharmacy / Thomas Bader (4/7/99): riboflavin injection
- Drugs Are Us / Hopewell Pharmacy / Gene Ragazzo and James Palmieri (6/7/04): adenosine monophosphate, human growth hormone, polidocanol, domperidone
- Farmacia La Salud / Raul Sanchez (3/26/08): Inhalant solutions
- Hal’s Compounding Pharmacy / Harold Keller (12/4/06): lidocaine, prilocaine, benzocaine, tetracaine, DMSO, progesterone, tretinoin
- Hawkins, Inc / John R. Hawkins (9/8/06): acyclovir, amitriptyline, cyclosporin A, dexamethasone, gentamicin
- Murray Avenue Apothecary / Susan Merenstein (1/7/08): "bioidentical" hormones
- New England Compounding Center / Barry J. Cadden (12/4/06): trypan blue ophthalmic solution, aminolevulinic acid, benzocaine, lidocaine, tetracaine, p-aminobenzoic acid (PABA)
- Newman, Inc. / Medi-Stat / Daniel A. Newman (3/26/08): Keto-Stat, Neuro-Stat, Neuro-Dystonia, Shingles TDO, and Gout TDO
- Pacifica Pharmacy / Jeffrey Barris (1/7/08): "bioidentical" hormones
- Palace Pharmacy / Joel Maertens (3/23/05): domperidone
- Panorama Compounding Pharmacy / Earl Broidy (1/7/08 "bioidentical" hormones
- Peoples Pharmacy / Bill Swail (6/7/04): betamethasone, cisapride, domperidone
- Pharmacy Compounding Specialties / James Porter (1/7/08): "bioidentical" hormones
- Professional Compounding Centers of America / David L. Sparks (7/27/01): phenacetin, dipyrone, dihydrostreptomycin sulfate, adenosine phosphate, chloroform
- Reed's Compounding Pharmacy / Thomas Reed, Dana Reed-King (1/7/08) : "bioidentical" hormones
- Saint John's Medical Plaza Pharmacy / Nancy Mavadat (1/7/08: "bioidentical" hormones
- Sargent's Drug Store / Glenn S. Balas (7/12/91): Sargenti root canal powder
- Spectrum Chemicals & Laboratory Products / Paul Burg (6/7/04): domperidone
- Spectrum Chemicals & Laboratory Products / Elizabeth Ferguson-Brown (11/28/05): adenosine monophosphate, domperidone, polidocanol
- Steven's Pharmacy / Charles T. Bonner (11/12/08): topical anesthetic products
- Tiberius, Inc. / James G. Castillo (12/4/06): fidocaine, prilocaine, phenylephrine, lidocaine, polidocanol, DNCB
- Village Compounding Pharmacy / Phil Pylant (1/7/08): "bioidentical" hormones
This page was revised on July 19, 2010.