Is Village Pharmacy Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

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 bei

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.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FloorParsippany, NJ 07054Telephone: (973) 331-4900FAX: (973) 331-4969

VIA UPS NEXT DAY AIRAnn Ervin, OwnerVillage Pharmacy1280 Yardville-Allentown RoadAllentown, New Jersey 08501-1830

From June 14, 2016, to June 22, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Village Pharmacy, located at 1280 Yardville-Allentown Road, Allentown, New Jersey 08501-1830. During the inspection, the investigators noted that drug products you produced, such as Hydroxyzine Pamoate 25 mg/ml Suspension, 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 failed to meet the conditions of section 503A of the FDCA, and in addition, the investigators noted serious deficiencies in your practices for producing non-sterile drug products, which put patients at risk.

Regulatory Context

B. Failure to Meet the Conditions of Section 503A

During the inspection, the FDA investigators noted that drug products produced by your firm failed to meet the conditions of section 503A. For example, the investigators noted that 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 do not meet the conditions of section 503A and are not eligible for the exemptions in that section from the requirement under sections 505, 502(f)(1) and 501(a)(2)(B) 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.