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  1. Warning Letters

WARNING LETTER

ProRx LLC MARCS-CMS 723704 —

Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:
Drugs
Recipient:
Recipient Name
Arthur Fletcher
Recipient Title
General Counsel
ProRx LLC

619 Jeffers Cir
Exton, PA 19341-2540
United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER
WL # 723704

April 7, 2026

Dear Mr. Fletcher:

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 April 27, 2022, and most recently on February 20, 2026. From September 9, 2025, to September 19, 2025, an FDA investigator inspected your facility, ProRx LLC, located at 619 Jeffers Cir, Exton, PA 19341. 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. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your facility on September 19, 2025, and an amended Form FDA 483 on October 10, 2025. We reviewed your October 24, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence on February 13, 2026. FDA also acknowledges that, on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance. 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, which is 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 drug product compounded using bulk drug substances to qualify for the exemptions under section 503B, the bulk drug substances that are used must appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug must appear on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).

In addition, for a compounded drug product to qualify for the 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)]).

Further, 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 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 (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (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. Your facility compounded drug products using tirzepatide bulk drug substance. For example, on (b)(4), your facility compounded (b)(4) vials of Tirzepatide 72MG/4ML injectable drug product and on (b)(4), your facility compounded (b)(4) vials of Tirzepatide 45MG/2.5ML injectable drug product, using tirzepatide bulk drug substance on both dates. These drug products compounded using tirzepatide bulk drug substance are not eligible for the exemptions provided by section 503B because tirzepatide does not appear on the 503B bulks list and was not used to compound a drug that appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A).3

2. Some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, Glutathione Injection 2000mg, and Tirzepatide Injection 45mg/2.5mL, did not include the following statement on the label: the statement “Not for Resale” (section 503B(a)(10)(A)(iii)(IX)). Additionally, some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, did not contain the following on the label: the established name of the drug (section 503B(a)(10)(A)(iii)(II)).

3. Your facility did not 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 (or any successor regulations).4 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include an adequate definition of what constitutes a “serious” adverse event (21 CFR 310.305(b)) and do not require the firm to promptly investigate a serious, unexpected adverse event and submit a follow-up report within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)).

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

Adulterated Drug Products

The FDA investigator noted that drug products 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 investigator noted:

1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 production area. Instead, your firm approved and distributed drug products that were produced with colony-forming unit (CFU) recoveries found on ISO 5 operator gloves and settle plates.

2. An operator blocked first air by placing gloved hands and/or forearms directly over open tray of stoppers intended to be sterile during critical in-process operations within the ISO 5 production areas.

3. You did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 laminar airflow workstation (LAFW). Specifically, an operator removed the outer packaging of stoppers in the ISO 7 area and the inner bag was then transferred from the ISO 7 area into the ISO 5 LAFW without surface disinfection. The inner bag of stoppers could be held for up to (b)(4) within the ISO 7 area before being transferred into the ISO 5 LAFW.

4. An operator used non-sterilized scissor within the ISO 5 processing area. This scissor was used to cut open a bag of stoppers inside the ISO 5 LAFW during filling operation of drug product intended to be sterile. This scissor was routinely stored in the ISO 7 area and was only wiped with (b)(4) wipe prior to use.

5. You had production areas or equipment that are difficult to clean or contain porous, particle-generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings). Specifically, the floor of the ISO Class 7 buffer room equipped with an ISO 5 LAFW and Biological Safety Cabinet (BSC) showed significant visible sporadic discoloration, the cause of which remains unknown.

The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

3. 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)).

4. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).

5. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

Outsourcing facilities must comply 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 issued a revised draft guidance, Current Good Manufacturing Practice — 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 until more specific CGMP regulations for outsourcing facilities are promulgated.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is 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 commerce and results in the drug being adulterated.

Unapproved New Drug Products

You do not have any FDA-approved applications on file for drug products that you compound.5 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 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.6 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.

D. Corrective Actions

We have reviewed your facility’s October 24, 2025, response to the Form FDA 483 and acknowledge receipt of your subsequent correspondence on February 13, 2026. We also acknowledge on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance.

Regarding your October 24, 2025 response related to the insanitary conditions and CGMP violations, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. Regarding your disinfectant efficacy studies, your response indicated initiating a comprehensive cleaning validation and disinfectant efficacy study on October 17, 2025, covering all disinfectants currently in use. You contracted (b)(4) to conduct efficacy testing against in-house isolates and common cleanroom contaminants, including molds and bacterial strains recovered during environmental monitoring (EM). While you agreed to share the protocol results with FDA once complete, the current status and expected completion timeline remain unclear, leaving questions about whether your existing cleaning disinfectants can adequately maintain your ISO 5 LAFWs, BSCs, and cleanroom environments.

2. Regarding your floor discoloration of the ISO 7 cleanroom, your response indicated that a deviation investigation and corrective action and preventive action (CAPA) plan were initiated to address this issue. You determined the root cause to be the use of (b)(4), which exceeded the (b)(4) tolerance threshold of your existing (b)(4) flooring. Your corrective action involves installing replacement flooring capable of withstanding your cleaning protocol, followed by third-party cleanroom certification. You have suspended all aseptic compounding pending certification completion. However, your response lacks critical documentation, including evidence of when flooring construction occurred, documentation verifying the new flooring's appropriateness for pharmaceutical cleanroom use, and a timeline for completing construction and resuming aseptic production.

Some of your corrective actions appear deficient:

1. Regarding your failure to conduct adequate investigations, our comprehensive review of your firm’s multiple deviation reports and SOPs reveals significant deficiencies in documentation and execution procedures for out-of-specification (OOS) events and deviation investigations. The following examples illustrate some of these deficiencies:

  • Your deviation reports (DEV-2025-05 and DEV-2025-06) provide only minimal information, such as the description of the deviation and the immediate action(s) taken. These reports lack critical details regarding the investigation into the root cause of the deviation.
  • Your firm has not established clear criteria for determining when investigations should be initiated following the opening of a deviation. Specifically, SOP QA-190 Deviation Procedure section 2.e. states, “Upon accepting the Deviation Form QA determines if an investigation and/or CAPA is required, checks the appropriate box (Yes or No), assigns and records the investigation and CAPA number.” However, your revised SOPs (SOP QA-190, QA-080 Root Cause Investigation Procedure, and QA-180 Corrective and Preventative Action (CAPA) Procedure) do not provide any details on the criteria for determining when a deviation warrants a formal investigation and CAPA. This represents a critical gap in your quality management system.
  • Your firm’s responses did not include any retroactive investigation or root cause analysis addressing the multiple microbial growth detected in personnel fingertip samples collected following production activities in the ISO 5 area. Nor did your firm perform any retroactive investigation or root cause analysis for the CFUs recovered from surface samples during (b)(4) EM of the ISO 5 areas.
  • Your response did not address why investigations were not extended to other batches produced by operators when contamination was recovered on consecutive days during personnel monitoring of those same operators. Furthermore, a passing sterility test result does not indicate the absence of contamination within a batch, as microbial growth is not uniformly distributed throughout a batch.
  • Your firm’s response regarding the recovery of 1 CFU of Trichoderma oriental from an air sample of the ISO 7 area during production of Tirzepatide 60mg/3mL on 01/16/25 was inadequate. While the 1 CFU recovered did not exceeded the ISO 7 acceptance limit, the nature of this microorganism necessitates further action. Since this organism is not part of the normal cleanroom flora and it was recovered during the capping process during the production of drug product intended to be sterile, your firm should have conducted an investigation and included this microbial recovery in the trending data.
  • Furthermore, your SOPs (SOP QA-190, QA-080, and QA-180) are missing signatories (author, reviewer, QA approver) and an effective date, making it unclear whether these represent the final, official version of these SOPs. In fact, the majority of SOPs you provided in your response lack these critical signatories that are essential for Good Documentation Practices (GDP) to ensure accountability, authorization, and data integrity (ALCOA principles: attributable, legible, contemporaneously recorded, original or a true copy, and accurate).

2. Regarding your firm’s deficiency in monitoring environmental conditions, your SOP CSP-080 Viable and Nonviable Air Sampling states viable air sampling “is conducted continuously during the compounding of CSPs in the ISO 5 environment by compounding personnel”. Our review of your SOPs and batch record reveals a fundamental misunderstanding of the distinction between active and passive viable air monitoring methods. Specifically, the viable monitoring documented in your batch record pertains to passive viable air monitoring (settle plate). While settle plates can provide valuable information about environmental monitoring conditions, they do not fulfill regulatory requirements. Active viable air monitoring is required under CGMP regulations. Furthermore, the viable air monitoring specification outlined in your SOP CSP-080 appears to address active viable air monitoring, yet no specifications are provided for the passive viable air monitoring.

Furthermore, your firm’s SOP CSP-090 Surface Sampling Procedure states, "Surface sampling must be performed in all ISO classified areas on a (b)(4) basis, or more frequently on a risk-based approach if trending excursions are identified." This is inadequate, as surface monitoring should be conducted at least (b)(4) during operations within the ISO 5 area.

3. Regarding your March 19, 2025, Dynamic Smoke Study, your response claimed the study demonstrated that first air to the stoppers was maintained and there was no contamination risk from your operator forearms during the stoppering process in your ISO 5 area. However, our review of your dynamic smoke study reveals several critical deficiencies that contradict these claims. The video footage shows operators extending their forearms and gloved hands directly over both the sterile stopper tray and open vial tray during stoppering operations in the ISO 5 hood, contradicting your assertion of no obstruction. Moreover, the stopper tray was empty during the smoke study, operators were simulating stopper pickup with tweezers and transfer over open vials rather than performing actual operations.

Additionally, the smoke study reveals significant airflow concerns in both the ISO 5 LAFW and ISO 7 cleanroom. The air movement exhibits an (b)(4) trajectory toward the ceiling rather than the top-down movement and dilution of HEPA filtered air in the ISO 7 cleanroom. This (b)(4) pattern in the ISO 5 LAFW suggests that vials and stoppers may not be receiving adequate first air protection. Furthermore, the vial tray positioning creates a raised lip around the tray perimeter that may further impede proper airflow and compromise sterile protection of open vials. Visible turbulence is evident over the vial tray, further indicating compromised airflow.

4. Regarding your media fills, your firm’s response indicates that SOP PT-020 Personnel Aseptic Qualification has been revised to require each operator to complete (b)(4) successful media fill runs that simulate actual production conditions. The revised SOP incorporates "best- and worst-case scenarios" with varying unit quantities (ranging from minimum of (b)(4) to a maximum of (b)(4)) and different fill volumes (1.2mL, 10.4mL and 30.4mL). However, your firm did not provide the media fill production batch record that would demonstrate how these requirements are implemented in your actual media fill procedures. Furthermore, while your response states all operators will be retrained and requalified on the revised SOP, no timeline was provided for completing this retraining and requalification.

5. Regarding your lack of change control, your firm’s response maintains that construction at your facility is occurring in an adjacent suite and poses no cross-contamination risk to the aseptic cleanroom. However, you did not provide any change control documentation, risk assessment, or other supporting evidence demonstrating how construction of a new facility within the same building does not pose a risk of cross-contamination and loss of environmental control. Such risks include particulate and microbial intrusion, personnel and material movement, and disruption of facility integrity.

Additionally, your firm’s response states you are implementing a robust change control system. However, review of your revised change control documents (QA-241 Change Control Form, QA-240 Change Control Management Procedure, and related training logs) reveals inadequate instructions and insufficient detail for personnel to properly assess and execute the change control process. Key deficiencies include Attachment #1: Change Impact and Risk Assessment Checklist, which appears to be a required component of the QA-241 Change Control Form but is not referenced in SOP QA-240. Neither document provides criteria for evaluating the impact and risk associated with each item within the checklist. The checklist uses a simple Yes/No format without requiring justification or rationale for conclusions and the impact/risk assessment checklist appears to depend solely on the requester rather than involving a multidisciplinary team or subject matter experts. The procedure fails to specify QA's approval or rejection criteria and does not clarify whether decisions rely exclusively on checklist responses. There are no provisions for assessing change effectiveness or consequences post-implementation.

6. Regarding your visual inspection (VI) program, your firm’s response indicates that you are “engaging all operating personnel in a robust visual inspection competency and training program.” However, your visual inspection documents (QA-220 Acceptance Sampling Procedure, CSP-140 Visual Inspection Procedure, and PT-100 Visual Inspection Qualifications Procedure) provided with your response contain significant deficiencies. For example, your visual inspection qualification exam uses only (b)(4) with a (b)(4) time limit, despite batch sizes that range from (b)(4). The exam also employs a scoring system that lacks clear scientific justification for the assigned point values.

Furthermore, your revised procedures eliminated the previous requirement for (b)(4) as part of your personnel qualification of operator conducting visual inspection. This requirement should be maintained as essential criteria for inspector qualification to ensure inspectors possess adequate visual acuity to identify defects. Additionally, your firm's SOP CSP-140 delegates defect categorization entirely to quality control (QC) personnel after inspection by your operations personnel. Your visual inspection procedures do not address the disposition of defective units identified by operators but not confirmed by QC personnel. It remains unclear whether such units would be included in batch release or rejected.

Your firm’s defect classification system for minor, major and critical defects remain inadequate. Your firm did not provide scientific justification for classifying all particulates as major defects. A risk-based approach should evaluate multiple factors—including particle size, route of administration, and whether particulates are extrinsic or intrinsic—to determine the appropriate defect classification. Additionally, SOP CSP-140 classifies loose and missing crimps as minor defects despite their potential to compromise container closure integrity, permit microbial ingress, and threaten sterility assurance of your drug product intended to be sterile.

We acknowledge that SOP QA-220 Acceptance Sampling Procedure establishes a framework for AQL statistical sampling and defines limits for minor, major, and critical defect classifications. However, your visual inspection competency and training program exhibits significant deficiencies, as discussed above. Given these deficiencies, it does not appear your firm can appropriately classify the different type and category of defects to adequately execute statistical sampling and classification.

Your firm’s response also does not address batch yield specification as part of the VI program. Lastly, your response does not discuss the implementation of defect library or the training of VI inspectors and QC personnel using this library.

In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]

Furthermore, regarding issues related to the conditions of section 503B of the FDCA, your corrective actions appear deficient: Although you submitted revised labels that adequately corrected the labeling deficiencies noted during the inspection, your revised label for Nicotinamide Adenine Dinucleotide no longer includes a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient, as required by section 503B(a)(10)(iii)(X).

You did not address certain issues related to the conditions of section 503B of the FDCA, for example:

1. You did not address the issue of your firm compounding drugs using tirzepatide bulk drug substance.

2. You did not submit updated documented procedures for reporting adverse events.

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.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

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 address 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 violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe 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.

All correspondence should refer to the Warning Letter Number above (# 723704) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.

Sincerely,
/S/

Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research

cc: Gregory G. Gaiser, Senior Vice President

____________________

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 These substances are also not within the scope of the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). This guidance describes FDA’s interim regulatory policy for entities registered as outsourcing facilities under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B bulks list and that is not used to compound a drug that appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503BCategory 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf

4 For more information, 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.

5 The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [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.

6 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).

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