Inspections, Compliance, Enforcement, and Criminal Investigations

Service First Pharmacies Inc, dba Madison Drugs 4/27/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

April 27, 2016
 
WARNING LETTER NO. 2016-NOL-03
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Terry A. Wingo, Owner
Service First Pharmacies, Inc., dba Madison Drugs
8 Parade Street NW
Huntsville, Alabama 35806
 
Dear Mr. Wingo:
 
From August 3, 4 and 13, 2015, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Service First Pharmacies, Inc., dba Madison Drugs, located at 8 Parade Street NW, Huntsville, Alabama. During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. 
 
Based on this inspection, it appears you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
 
A. Compounded Drugs Under the FDCA
 
Section 503A of the FDCA [21 United State Code (USC) 353a] describes the conditions under which certain compounded human drug products may qualify for exemptions from three sections of the FDCA:  compliance with current good manufacturing practice (CGMP) requirements, Section 501(a)(2)(B) of the FDCA [21 USC 351(a)(2)(B)]; labeling with adequate directions for use, Section 502(f)(1) of the FDCA [21 USC 352(f)(1)]; and FDA approval prior to marketing, Section 505 of the FDCA [21 USC 355].  Receipt of valid prescriptions for individually-identified patients is one of the conditions necessary to qualify for the exemptions under Section 503A. 
 
During the FDA inspection, the investigator noted your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce.
 
Accordingly, the drugs you compound without valid prescriptions for individually identified patients are not entitled to the exemptions in Section 503A.
 
In addition, we remind you there are other conditions that must be satisfied to qualify for the exemptions in Section 503A of the FDCA.[1]
 
B. Violations of the FDCA
 
The drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are misbranded drugs in violation of Section 502(f)(1) of the FDCA.
 
Misbranded Drug Products
 
You compound drug products, for which you have not obtained valid prescriptions for individually-identified patients, which are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the FDCA, and they are not exempt from the requirements of Section 502(f)(1) of the FDCA (see, e.g., Title 21, Code of Federal Regulations (CFR) 201.115). 
 
It is a prohibited act under Section 301(k) of the FDCA [21 USC 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.  
 
C. Corrective Actions
 
FDA acknowledges your commitment, as discussed with the investigator at the close of the inspection, to cease the practice of manufacturing and distributing compounded drug products without prescriptions for individually-identified patients. 
 
If you continue to manufacture and distribute drug products without valid prescriptions for individually-identified patients, the manufacture of such drugs would be subject to FDA’s drug CGMP regulations for Finished Pharmaceuticals, 21 CFR 210 and 211, among other requirements described above.
                                                                                                                                                    
D. Conclusion
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. 
 
Your written notification should be addressed to Mark W. Rivero, Compliance Officer, at the address listed above.  If you have questions regarding any issues in this letter, please contact Mr. Rivero at mark.rivero@fda.hhs.gov or by phone at (504) 846-6103.
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District
  
 
cc:   Alabama State Board of Pharmacy
        111 Village Street
        Hoover, Alabama 35242
 

[1]The Compounding Quality Act (CQA) contains a number of other provisions, including new exemptions and requirements for compounders seeking to operate as outsourcing facilities. A discussion of the CQA and the agency’s plans to implement the new law may be found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm

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