Bellevue Pharmacy Solutions.

St. Louis, MO, Jan. 14 (Kansas City)

Based on the firm's website, www.bphartnacysolutions.com, and mailed advertisements to physicians, FDA wrote, "it has come to our attention that your firm compounds and distributes drugs, including hyaluronidase, progesterone, diphenhydramine, dimenhydrinate, folic acid, pyridoxine, thiamine, and EDTA (edetate disodium). It appears that your firm also compounds products containing polidocanol, cantharidin, estriol and domperidone, which are not components of any FDA-approved drug." The agency wrote that such compounding would violate the FD&C Act.

The agency wrote that compounded drugs are new drugs because they are not "generally recognized, among experts ... as safe and effective" for their labeled uses. Thus, compounded drugs may not be introduced into interstate commerce without FDA approval.

FDA said it has long recognized the important public health function served by traditional pharmacy compounding. Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced drug, or diluted dosages for children.

FDA's current enforcement policy with respect to the compounding of human drugs is articulated in its Compliance Policy Guide, which identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding. These factors help differentiate the traditional practice of pharmacy compounding from the manufacture of unapproved new drugs. They further address compounding practices that result in significant violations.

The firm's Website indicates that it compounds drugs including:

* Hyaluronidase 150 units/ml injections

* Progesterone 100 mg/200 mg capsules

* Diphenhydramine 50 mg/ml injections

* Dimenhydrinate 50 mg/ml injections

* Folic Acid 5 mg/ml injections

* Pyridoxine Hydrochloride 100 mg/ml injections

* Thiamine Hydrochloride (B-1) 100 mg/ml injections

* Edetate Disodium (EDTA) 150 mg/ml injections

FDA concluded that "These products are copies or essentially copies of FDA-approved drugs and appear to be compounded without a patient-specific medical need, as determined by a licensed health care provider, for their variation from the FDA-approved, commercially-available drugs with which they compete. We will not exercise enforcement discretion toward your firm's continued compounding of these drugs."

The firm's promotional materials offer compounding services for products that are not components of FDA-approved drugs, including polidocanol 5% injection, cantharidin and hormone therapy drugs containing estriol.

"FDA is concerned with the public health risks associated with the compounding of polidocanol. Known adverse events include deep venous thromboses, necrosis, and ulceration at the treated site with polidocanol. Reversible cardiac arrest after polidocanol sclerotherapy has been reported," the agency wrote.

Further, cantharidin and estriol are not components of an FDA-approved drug, and the firm compounds these products without FDA-sanctioned INDs.

"We also have reason to believe that your firm may be compounding domperidone," FDA wrote.

The agency said it is concerned with the public health risks associated with the compounding of domperidone, due to several published reports and case studies of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from the market in several countries. While domperidone is approved in several other countries for the treatment of gastric stasis and gastroparesis, it is not approved in any country for enhancing breast milk production in lactating women.

In several countries where the oral form of domperidone continues to be marketed, labels for the product note that domperidone is excreted in the breast milk of lactating women and recommend that women taking domperidone avoid breastfeeding. Because of this, FDA recommends that breastfeeding women not use domperidone to increase milk production.

Polidocanol, cantharidin, estriol and domperidone are not active ingredients contained in any FDA-approved drug. FDA did not sanction their use in pharmacy compounding and will not exercise enforcement discretion with respect to products that contain these ingredients.

The aforementioned products compounded by the firm are new drugs, FDA concluded, and "may not be introduced or delivered for introduction into interstate commerce because no approval of an application filed is in effect for them."

In addition, these drugs are misbranded because their labeling fails to bear adequate directions for their use. Compound; NDA; Web