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September 20, 2021

Case # 610751

WARNING LETTER

Mr. Gilbert:

You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]¹ on July 3, 2019 and most recently on November 19, 2020. From October 28, 2019 to November 12, 2019, an FDA investigator inspected your facility, Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop located at 8400 Esters Blvd, Suite 190, Irving, Texas 75063. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA.

FDA issued a Form FDA 483 to your facility on November 12, 2019. FDA acknowledges receipt of your facility’s responses, dated November 29, 2019 and December 31, 2019, as well as your subsequent correspondence. Based on this inspection, it appears you produced drugs that violate the FDCA.

A. Compounded Drug Products under the FDCA

Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.²

An outsourcing facility, as defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding 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 the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.

In addition, for a compounded drug product to qualify for exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).

Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b) including the requirement to submit a report to FDA upon initially registering as an outsourcing facility, once in June of each year, and once in December of each year identifying the drug products compounded during the previous 6-month period (section 503B(b)(2) of the FDCA [21 U.S.C. §353b(b)(2)]) and the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations” (section 503B(b)(5) of the FDCA [21 U.S.C. § 353b(b)(5)]).

B. Failure to Meet the Conditions of Section 503B

During the inspection, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator noted:

1. Some of your facility’s drug products did not include the National Drug Code number on the label (section 503B(a)(10)(A)(iii)(VIII) of the FDCA [21 U.S.C. § 353b(a)(10)(A)(iii)(VIII)]). For example, the drug product labels for Estradiol Pellet 6mg (NDC 71138-0006-01) and Testosterone Pellet 25mg (NDC 71138-1025-01) did not include the National Drug Code numbers. In addition, the container from which individual units of some of your facility’s drug products are removed for dispensing or for administration, including Estradiol Pellet 6mg and Testosterone Pellet 25mg, did not include directions for use (section 503B(a)(10)(B)(iii)) of the FDCA [21 U.S.C. §353b(a)(10)(B)(iii)]).

2. The report your facility submitted to FDA upon initial registration, in July 2019, failed to identify all the drug products that you compounded during the previous 6-month period, including HCG Methylcobalamin B12 1000IU Injection, Testosterone Pellets-25mg, 37.5mg, 50mg, 100mg, & 200mg, Estradiol Pellets-6mg, 10mg, 12.5mg, & 15mg, Testosterone/Anastrozole Pellets-75mg/4mg & 100mg/4mg and Testosterone cypionate/ Testosterone propionate 200mg/10mg Injection.

3. Your facility failed to submit adverse event reports to FDA as required by section 503B(b)(5) and 21 CFR 310.305. Specifically, FDA received a report of an adverse drug experience from your firm on October 31, 2019, regarding a patient who was diagnosed with (b)(6) after administration of your compounded Testosterone 25mg, Testosterone 50mg, and Testosterone 87.5 mg pellets. However, your firm became aware of this adverse drug experience on September 26, 2019. An outsourcing facility must submit to FDA reports of all serious, unexpected adverse drug experiences associated with their compounded drug products as soon as possible, but no later than 15 calendar days after first receiving information about the adverse drug experience (21 CFR 310.305(c)(1)).

Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.

Specific violations are described below.

C. Violations of the FDCA

Unapproved New Drug Products

You do not have any FDA-approved applications on file for drug products that you compound.³ Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 331(d)], 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. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.

Misbranded Drug Products

You compound drug products that 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 causing them to be misbranded under section 502(f)(1) of the FDCA.⁴ The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also 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 being misbranded.

Failure to Report Drugs

As noted above, your facility failed to submit a complete report to FDA upon initial registration as an outsourcing facility in July 2019, identifying all the drug products that you compounded during the previous 6-month period (section 503B(b)(2) of the FDCA). The failure to report drugs by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].

Failure to Report Adverse Events

As noted above, your facility failed to submit adverse event reports in accordance with section 503B(b) and 21 CFR 310.305. The failure to report adverse events by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].

D. Corrective Actions

We have reviewed your facility’s responses to the Form FDA 483 and your subsequent correspondence.

Regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear adequate:

1. The product report submitted in December 2019 appears to identify all the drug products that you compounded during the previous 6-month period, including the products not reported upon initial registration in July 2019.

2. You provided documentation of a “revised Adverse Drug Event (ADE) SOP to include calendar invitations…to ensure report is submitted within 15-day requirement” and [r]etrained all employees on [this] ADE SOP.” Please note that we are unable to fully evaluate whether the aforementioned SOP is consistent with the content and format requirements established through regulation under section 310.305 of title 21, Code of Federal Regulations, because the documentation provided is incomplete.⁵

However, you did not address labeling issues related to the conditions of section 503B of the FDCA. FDA reminds you that drug products produced in a 503B-registered outsourcing facility must be labeled in accordance with section 503B as one of the conditions necessary to qualify for the exemptions under section 503B of the FDCA (Section 503B(a)(10), [21 U.S.C. § 353b(a)(10)]).

Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.

Furthermore, during the inspection, the FDA investigator noted that your facility compounded drug products that are (1) not identical or nearly identical to an approved drug product and (2) the component of which is a bulk drug substance that is a component of an approved drug product.

Please be advised that FDA intends to consider such products to be essentially a copy of an approved drug product under section 503B(d)(2)(B) of the FDCA unless the prescribing practitioner determines that there is a change that produces a clinical difference for an individual patient. If you intend to rely on such a determination to establish that a compounded drug is not essentially a copy of an approved drug, you should ensure that the determination is noted on the prescription or order (which may be a patient-specific prescription or a non-patient specific order) for the compounded drug.

We do acknowledge your firm’s intention to not compound drug products that are essentially a copy of one or more approved drug products.

E. 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 any violations 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.

You should take prompt action to correct any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. If you believe that your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so. Your written notification should refer to the Warning Letter Number above (Case # 610751). Please electronically submit your signed reply on your firm’s letterhead to CDR John W. Diehl, M.S., Director, Compliance Branch, at [email protected] and [email protected].

If you have questions regarding the contents of this letter, you may contact Mr. Thao Ta, Compliance Officer, via phone at 214-253-5217 or e-mail at [email protected].

Sincerely,
/S/

Tamala Bogan
Acting Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

cc:

Via Electronic Mail
Donald Prentiss, President of Operations
Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
8400 Esters Blvd, Suite 190
Irving, Texas 75063-2217
(b)(6)

Ann Driscoll, Director of Operations
Texas State Board of Pharmacy
333 Guadalupe Street, Suite 3-500
Austin, Texas 78701-3943
[email protected]

_______________________________________

1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

2 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.

3 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 and/or because they are intended to affect the structure or any function of the body. 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.

4 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

5 See FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.