Inspections, Compliance, Enforcement, and Criminal Investigations

Right Value Drug Stores, Inc. 7/25/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128 

 

July 25, 2016
 
2016-DAL-WL-31
 
WARNING LETTER
UPS Overnight
 
Richard E. Appling, Owner/President
Right Value Drug Stores, Inc., dba Carie Boyd’s Prescription Shop
122 Grapevine Highway
Hurst, TX 76054-2406
 
Dear Mr. Appling:
 
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.
 
A. Compounded Drugs Under the FDCA
 
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. 
 
Generally, CGMP requirements for finished drug products are established in Title 21 of the Code of Federal Regulations (CFR) Parts 210 and 211. 
 
B. Violations of the FDCA
 
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. 
 
Unapproved New Drug Products
 
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. [1] 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.
 
Misbranded Drug Products
 
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.
 
Adulterated Drug Products
 
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. 
 
FDA investigators also noted CGMP violations at your facility, causing the drug products for which you had not obtained valid prescriptions for individually-identified patients before you registered as an outsourcing facility, to be adulterated under section 501(a)(2)(B) of the FDCA. The violations include, for example:
 
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)).
 
2.    Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination (21 CFR 211.28(a)).
 
3.    Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
 
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)).
 
Before you registered as an outsourcing facility, the CGMP violations described above applied only to the drug products for which you did not obtain valid prescriptions for individually-identified patients. Now that you are an outsourcing facility, all of your drugs must be made in accordance with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has also issued a draft guidance, Current Good Manufacturing Practice —Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR Parts 210 and 211 during this interim period. 
 
C. Corrective Actions
 
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.
 
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. You should fully implement necessary corrections in order to ensure that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.  
 
D. Conclusion
 
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.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
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 the corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be completed. Your written notification should refer to the Warning Letter Number above (2016-DAL-WL-31). Please address your reply to:
 
Jeffrey Wooley, Compliance Officer
FDA Dallas District Office
U.S. Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 75204
 
If you have questions regarding the contents of this letter, please contact Mr. Wooley at phone at 214-253-5251.
  
 
Sincerely,
/S/ 
Amy Barringer
Acting District Director
Dallas District


[1]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. 

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