Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526002.htm
Timestamp: 2019-04-21 14:55:53+00:00

Document:
From December 2, 2014, to December 12, 2014, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Right Value Drug Stores, Inc., dba Carie Boyd’s Prescription Shop, located at 122 Grapevine Highway, Hurst, TX 76054-2406.
During this inspection, the investigators noted that you were not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators observed that operators produced sterile drug products in the ISO 5 and ISO 7 areas with exposed facial skin and hair, as well as exposed wrists. In addition, your firm did not use a sporicidal agent, sterile wipes, or sterile disinfectants as part of the disinfection program for the ISO 7 areas and the ISO 5 hoods.
A Form FDA 483 was issued to your firm on December 12, 2014. FDA acknowledges receipt of your firm’s response, dated January 5, 2015. Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
FDA acknowledges that Carie Boyd’s Prescription Shop registered its facility with FDA as a 503B outsourcing facility on January 11, 2016.
Section 503A of the FDCA [21 U.S.C. § 353a] describes the conditions under which certain compounded human drug products 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, section 505 of the FDCA [21 U.S.C. § 355]. Receipt of valid prescriptions for individually-identified patients is one of the conditions that must be met for drug products to qualify for the exemptions under section 503A.
During the FDA inspection, the investigators observed that your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced. Accordingly, the drugs you compounded without valid prescriptions for individually identified patients before you registered as an outsourcing facility are not entitled to the exemptions in section 503A.
As previously noted, we acknowledge that you registered your facility with FDA as a section 503B outsourcing facility on January 11, 2016. Drug products compounded in a registered outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FDCA [21 U.S.C. § 355] and the requirement to label products with adequate directions for use under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] if the drug is compounded by or under the direct supervision of a licensed pharmacist and all of the conditions in section 503B are met. An outsourcing facility compounding under section 503B may or may not obtain prescriptions for individually-identified patients.
In addition, outsourcing facilities must comply with other provisions of the FDCA, including section 501(a)(2)(B) regarding compliance with current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)] regarding insanitary conditions.
Because the drug products that you manufactured and distributed without valid prescriptions for individually-identified patients before you registered as an outsourcing facility were not the subject of approved applications, they are unapproved new drugs and misbranded drugs in violation of sections 505(a) and 502(f)(1) of the FDCA, respectively. In addition, drug products that are intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health causing them to be adulterated within the meaning of section 501(a)(2)(A) of the FDCA. Furthermore, because you manufactured and distributed a portion of your drugs without valid prescriptions for individually-identified patients before you registered as an outsourcing facility, the manufacture of those drugs is also subject to FDA’s CGMP regulations for Finished Pharmaceuticals, 21 CFR, Parts 210 and 211. FDA investigators observed significant CGMP violations at your facility, causing your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.
You do not have any FDA-approved applications on file for the drug products for which you did not obtain valid prescriptions for individually-identified patients before you registered as an outsourcing facility.  Under sections 301(d) and 505(a) of the FDCA [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Your marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
The drug products that you compounded without obtaining valid prescriptions for individually-identified patients before you registered as an outsourcing facility 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 failed to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FDCA. The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA [21 U.S.C, § 331(a)]. It is also a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 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 and results in the drug being misbranded.
FDA investigators noted that drug products in your facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that operators produced sterile drug products in the ISO 5 and ISO 7 areas with exposed facial skin and hair, as well as exposed wrists. In addition, your firm did not use a sporicidal agent, sterile wipes, or sterile disinfectants as part of the disinfection program for the ISO 7 areas and the ISO 5 hoods.
2. Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination (21 CFR 211.28(a)).
4. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).
5. Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements (21 CFR 211.167(a)).
We acknowledge your action on December 12, 2014, to voluntarily recall all lots dispensed in the prior six months of Glutathione 200 mg/mL Injectable, and your response to the Form FDA 483 dated January 5, 2015, in which you stated your firm’s (b)(4).
In your response, received on January 5, 2015, you described certain corrective actions you took in response to the Form FDA 483 observations. Since providing these responses, you subsequently registered as an outsourcing facility, and are subject to CGMP requirements.
Although your proposed corrective actions appear to address some of the deficiencies observed at your facility, your response to several of the observations does not include sufficient information to evaluate the adequacy of your proposed actions. For example, your response states that the environmental monitoring frequency will be increased. However, it does not include a complete description of the new procedures for environmental monitoring of the cleanrooms. The implementation and adequacy of your firm’s planned corrective actions will be verified during FDA’s next inspection.
If you have questions regarding the contents of this letter, please contact Mr. Wooley at phone at 214-253-5251.
The specific products made by your firm are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

References: § 353
 § 351
 § 352
 § 355
 § 355
 § 352
 § 351
 § 331
 § 331
 § 321
 § 321