Carlton's Dunwoody Pharmacy Corp FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The ineligible drug products you compounded are intended for conditions 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, and they are not exempt from the requirements of Section 502(f)(1) of the FDCA (see, e.g., 21 CFR 201.115). Accordingly, these ineligible drug products are misbranded under Section 502(f)(1) of the FDCA. It is a prohibited act under Section 301(k) of the FDCA 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 bein

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.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your written notification should refer to the Warning Letter Number above (CMS Case # 512043).

Potential Health Risks

Office of Pharmaceutical Quality Operations, Division II4040 N. Central Expressway, Suite 300Dallas, Texas 75204

Marvin O. McCord, OwnerCarlton’s Dunwoody Pharmacy Corporation5484 Chamblee Dunwoody Rd.Dunwoody, Georgia 30338

From January 5, 2016 to January 13, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Carlton’s Dunwoody Pharmacy Corp., located at 5484 Chamblee Dunwoody Rd., Dunwoody, Georgia 30338-4133. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA. Specifically, the investigators noted that you did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.

Regulatory Context

B. Failure to Meet the Conditions of Section 503A

During the inspection, FDA investigators noted that drug products produced by your firm failed to meet the conditions of Section 503A. For example, the investigators noted your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.

Therefore, you compounded drug products (collectively the “ineligible drug products”) that did not meet the conditions of Section 503A and are not eligible for the exemptions in that Section from the FDA approval requirement of Section 505 of the FDCA, the requirement under Section 502(f)(1) of the FDCA that labeling bear adequate directions for use, and the requirement of compliance with CGMP under Section 501(a)(2)(B) of the FDCA.