Department of Health and Human Services
Public Health Service
Denver District Office
March 23, 2005
RETURN RECEIPT REQUESTED
Mr. Joel Maertens, R.Ph
166 West Main Street
Lander, Wyoming 82520
Ref # - DEN-05-08
Dear Mr. Maertens:
On September 13, 2004, investigators from the U.S. Food and Drug Administration (FDA) and the Wyoming State Board of Pharmacy inspected Palace Pharmacy, 166 West Main Street, Lander, Wyoming. This inspection revealed that your firm compounds human prescription drugs in various dosage forms and strengths.
As you may be aware, Section 127 of the FDA Modernization Act of 1997 amended the Federal Food, Drug and Cosmetic Act (the Act) by adding section 503A, which specified certain conditions under which compounded human drugs could be exempt from particular requirements of the Act. In April 2002, however, the United States Supreme Court struck down the commercial speech restrictions in section 503A of the Act as unconstitutional . Accordingly, all of section 503A is now invalid.
As a result, the agency now utilizes its longstanding policy to exercise its enforcement discretion regarding certain types of pharmacy compounding. This policy is articulated in Compliance Policy Guide, section 460.200, issued June 7, 2002 ("the CPG'). The CPG contains factors that the agency considers in deciding whether to exercise its enforcement discretion. One factor is whether a firm is compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without FDA sanctioned investigational new drug applications.
The factors listed in the CPG are not intended to be exhaustive, and other factors may also be appropriate for consideration, including factors that indicate that a compounded product may have a potential adverse affect on the public health.
The inspection documented that your firm prepares and distributes 10mg, 15 mg, and 20 mg domperidone capsules for human use.
The agency is concerned with the public health risks associated with the compounding of domperidone. There have been 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arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in several countries. Among other uses, FDA has become aware of the use of domperidone by lactating women to increase breast milk production because of its effect on prolactin levels . While domperidone is approved in several other countries for the treatment of gastric stasis and gastropaiesis, domperidone 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 breast-feeding. Because of this, FDA recommends that breastfeeding women not use domperidone to increase milk production.
Domperidone is not an active ingredient contained in any FDA-approved drug product. FDA does not sanction its use in pharmacy compounding and will not exercise its enforcement discretion for compounded products containing domperidone.
All products compounded by your firm containing domperidone are drugs within the meaning of section 201(g) of the Act. These products are misbranded under 502(f)(1) of the Act in that their labeling fails to bear adequate direction for their use. Further, these products are not exempt from this requirement under 21 CFR § 201.115, because they are new drugs within the meaning of section 201(p) of the Act and they lack approved applications filed pursuant to section 505 of the Act.
Please be advised that if the domperidone products compounded by your pharmacy leave the State of Wyoming, then they would also violate section 505 of the Act.
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that all drug products compounded and processed by your pharmacy comply with federal laws and regulations.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in additional regulatory action without further notice. These actions include, but are not limited to, seizure of your products or injunction. Federal agencies are routinely advised of the issuance of warning letters so that they may take this information into account when considering the award of government contracts.
Please notify this office in writing within 15 working days of receipt of this letter, of any steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time frame within which the correction will be completed.
You should address your reply to this letter to the U.S. Food and Drug Administration, Denver District Office, P. O. Box 25087, Denver, CO 80225-0087, Attention: Regina A. Barrell, Compliance Officer. If you have any further questions, please feel free to contact Ms. Barrell at (303) 236-3043.
B. Belinda Collins
This page was posted on August 8, 2009.