SERIOUS DEFICIENCIES ARE NOTED IN THE PRACTICE OF PRODUCING STERILE DRUGS
BACKGROUND
Recently the FDA has been criticized for its management of the New England Compounding Center. The following Warning Letter represents one of the first Warning Letters that the Agency has issued in a similar area since the issue of Compounding Pharmacies has become a national topic.
The document highlighted below provides insight as to how the FDA is now managing this problem. Of note is the fact that even though the State of South Carolina lifted a suspension of Medi-Fare’s pharmacy license, the FDA, in a teleconference with the Client “informed you (the Client) that you should not resume production of sterile drugs until you implement appropriate corrective actions”.
“Between December 10, 2012, and January 18, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Medi-Fare Drug and Home Health Center, Inc., located at 300 W. Pine Street in Blacksburg, South Carolina 29702. During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a significant number of drug products you were producing. In addition, the investigator observed serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk. These observations and others were noted on an FDA Form 483 issued on January 18, 2013. We acknowledge receipt of your firm’s letter to FDA dated December 12, 2012, as well as your firm’s response to the FDA Form 483 dated January 29, 2013.
On February 28, 2013, we held a teleconference with you. Among other issues discussed, we expressed our concerns related to the design of your firm’s aseptic fill areas, which places sterile products at considerable risk of microbial contamination. As evidenced by photographs taken by the FDA investigator during the inspection your firm’s aseptic fill area is (b)(4) In addition, other activities, including labeling and weighing of non-sterile ingredients, are performed in this same room where sterile product is manipulated, creating a risk of contamination.
We are aware that the South Carolina Board of Pharmacy has recently lifted a suspension of your pharmacy license to produce sterile products. During our February 28, 2013 teleconference, we informed you that you should not resume production of sterile drugs until you implement appropriate corrective actions. You stated that you did not intend to resume production of sterile drugs until appropriate corrective actions have been implemented. We expect that you will notify this office before resuming production of sterile drugs.
Based on this inspection, it appears that you are producing drugs that do not fall within the exemptions for compounded drugs described in section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) or within the agency’s exercise of enforcement discretion set forth in Compliance Policy Guide 460.200 on Pharmacy Compounding (CPG) (2002).1
A. Compounded Drugs Under the FDCA
Currently, there are conflicting judicial decisions regarding the applicability of section 503A of the FDCA [21 U.S.C. § 353a), which exempts compounded drugs from several key statutory requirements if certain conditions are met.2 Nevertheless, receipt of valid prescriptions for individually-identified patients prior to distribution of compounded drugs is relevant for both section 503A of the FDCA and the agency’s CPG. During the FDA inspection, the investigator observed that your firm does not receive valid prescriptions for individually-identified patients for a significant number of the drug products you produce. Based on this factor alone, those drugs are not entitled to the statutory exemptions for compounded drugs described in section 503A of the FDCA and do not qualify for the agency’s exercise of enforcement discretion set forth in the CPG.3 In addition, we remind you that there are other conditions that must be satisfied to qualify for the exemptions in section 503A of the FDCA, as well as other factors that FDA considers in determining whether to exercise enforcement discretion under the CPG.4
Because the drug products that you manufacture and distribute without valid prescriptions for individually-identified patients are not the subject of approved applications, they are unapproved new drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§ 355(a) and 352(f)(1)] of the FDCA, respectively. In addition, because you manufacture and distribute drugs without valid prescriptions for individually-identified patients, the manufacture of those drugs remains subject to FDA’s Current Good Manufacturing Practice (CGMP)regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. FDA investigators observed significant CGMP violations at your facility, causing such drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].”
The entire Warning Letter may be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm343340.htm
Barry A Friedman, PhD LLC 