Dougherty's Pharmacy FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes [21 CFR 211.113(b)].

The ineligible drug products you compounded 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, and they are not exempt from the requirement to have labeling with adequate directions for use, 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., 21 CFR § 201.115).

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 and FDA regulations.

Potential Health Risks

From December 8, 2015, to December 29, 2015, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Dougherty’s Pharmacy Preston Royal, located at 5959 Royal Ln., Suite 515, Dallas, Texas  75230.  This inspection was conducted after receipt of a complaint about the lack of efficacy of alprostadil injections prepared by your firm.

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].  Specifically, the investigators noted that you did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.  In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk.  For example, during aseptic production of a sterile drug product, our investigators observed an operator reaching over open containers and therefore blocking first air within the ISO 5 area.  In addition, our investigators observed an operator failing to sanitize components prior to int

Section 503A of the FDCA [21 U.S.C. § 353a] describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, 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 U.S.C. § 351(a)(2)(B)]; labeling with adequate directions for use, section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]; and FDA approval prior to marketing of the FDCA, section 505 [21 U.S.C. § 355]1.   Receipt of valid prescriptions for individually-identified patients is one of the conditions necessary to qualify for the exemptions under section 503A of the FDCA.

Regulatory Context

B. Failure to Meet the Conditions of Section 503A

During the FDA inspection, the investigators observed that 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 of the FDCA.

Therefore, you compounded drug products (collectively the “ineligible drug products”) that do 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.