WARNING LETTER

GenoGenix LLC MARCS-CMS 718739 — January 20, 2026

Delivery Method:: VIA Electronic Mail
Product:: Drugs

Recipient:: Recipient Name

Samuel Miron; Recipient Title

Chief Executive Officer; GenoGenix LLC; 2840 NW 2nd Ave, Suites 204 & 205
Boca Raton, FL 33431-6692
United States

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

WARNING LETTER
WL # 718739

January 20, 2026

Dear Mr. Miron:

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 February 4, 2025. From July 14, 2025, to July 18, 2025, FDA investigators inspected your facility, GenoGenix LLC, located at 2840 NW 2nd Ave, Suites 204 & 205, Boca Raton, FL 33431. During the inspection, the investigators 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 investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.

FDA issued a Form FDA 483 to your facility on July 18, 2025, and issued an amended Form FDA 483 on July 31, 2025. We reviewed your August 29, 2025, September 30, 2025, October 31, 2025, and November 30, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. FDA acknowledges that your firm has ceased drug production and distribution. FDA also acknowledges that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination. 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 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)(i) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).

Furthermore, 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)]).]

Moreover, 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 (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 investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted:

1. Your facility compounded drug products using bulk drug substances that are not eligible for the use in compounding under section 503B, including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+). Drug products compounded using 5-Amino-1MQ and NAD+ are not eligible for the exemptions provided by section 503B, because 5-Amino-1MQ and NAD+ do not appear on the 503B bulks list and are not used to compound a drug that appears on the drug shortage list.³

2. Some of your facility’s drug products did not include the following required information on the label:

a. The statement “this is a compounded drug.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.

b. The name, address, and phone number of the outsourcing facility. Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.

c. The established name of the drug. Examples include Rapamycin, Clear Mind 150, and LIPO (MIC) + B.

d. The dosage form of the drug. Examples include LIPO (MIC) + B, Ascorbic Acid Vitamin C, Alpha Lipoic Acid, and Epithalon.

e. Storage and handling instructions. Examples include Epithalon.

f. The statement “Not for resale,” and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement “Office Use Only.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.

3. Some of your facility’s drug products did not include a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient on the label or container. Examples include Rapamycin, Clear Mind 150, Alpha Lipoic Acid, and Epithalon.

4. Some of your facility’s drug products did not include the following information on the container:

a. Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088.

b. Directions for use, including, as appropriate, dosage and administration.

Examples include Immune Defense Nasal Spray.

5. Your facility failed to submit a report to FDA upon initially registering as an outsourcing facility in February 2025 and in June 2025 identifying the drug products that you compounded during the previous 6-month period.

6. 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, you do not have any documented procedures for reporting adverse events.

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

FDA investigators 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 investigators observed that:

1. An operator blocked first air by placing gloved hands directly over open sterile containers.

2. An operator manually touched a product contact surface by reaching into a bag of stoppers with gloved hands, then hand stoppered vials of drug product.

3. Operators did not disinfect materials at each transition from areas of lower quality air to areas of higher quality air.

4. An operator placed components within the ISO (b)(4) hood that had the potential to block the movement of first air to critical in-process operations.

5. Personnel engaged in aseptic processing while exposing skin within the ISO (b)(4) aseptic processing area.

6. Personnel performing sterile operations never conducted media fills. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

7. Your firm lacks adequate routine environmental monitoring. Specifically, your firm has never performed personnel or environmental monitoring during the production of drug products.

8. Your firm failed to conduct (b)(4) testing on (b)(4) used to sterilize drug products. Therefore, you do not have assurance that the (b)(4) throughout use.

9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

10. Your cleanroom is outfitted with HEPA filters directly adjacent to the return vents in the ceiling. This design may prevent the dilution of particle-laden air by HEPA filtered air. Therefore, your firm has no assurance of proper air circulation within your cleanroom where aseptic production occurs.

11. Your production areas are difficult to clean and contain porous surfaces.

12. Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area. Specifically, your cleanroom sliding glass doors have visible gaps that could compromise the integrity of the controlled environment. These openings create pathways for uncontrolled air movement and potential contamination transfer.

13. Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.

14. Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product’s intended use.

FDA investigators 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 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 establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

3. 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).

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

5. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

6. Your firm failed to establish and follow written procedures prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to ensure that the reprocessed batches conform to all established standards, specifications, and characteristics (21 CFR 211.115(a)).

7. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

8. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

9. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

10. Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).

11. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

12. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).

In addition, FDA investigators noted that your firm released and distributed several drug products in which the strength did not meet the label claim. For example, your firm released and distributed injectable methylcobalamin 5,000 mcg/mL, which was determined to have 65.3% the amount of methylcobalamin listed on the label, and injectable B Complex, which was determined to have 43.1% the amount of dexpanthenol listed on the label. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. The strength of these compounded drug products differed from the strength represented on their labels, causing them to be adulterated under section 501(c) of the FDCA.

Furthermore, FDA investigators noted your firm released and distributed a drug product that contained excessive bacterial endotoxins. More specifically, your firm initiated a complaint investigation after receiving a notification from a healthcare provider that three patients had developed adverse symptoms, including low blood pressure, uncontrollable shaking, shivers, and body aches shortly after or during the administration of a product compounded by your firm containing NAD+. According to the complaint report, these three patients received NAD+ Lot# GG121624-023 from the same vial and were directed to the emergency room. This product was compounded by your firm, but you did not perform any finished product testing prior to release. As part of your investigation, your firm sent the product in question to a contract laboratory for testing. An unopened vial from the same lot was found to contain excessive bacterial endotoxins with a reported value of 3,360 EU/mL. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your firm’s compounded product containing NAD+ is adulterated under section 501(c) of the FDCA.

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 Furthermore, you do not have any FDA-approved applications on file for the drug products that you repackage, such as Semaglutide, Tirzepatide, and Retatrutide.⁶ 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.⁷

In addition, you do not have any FDA-approved applications on file for certain other products that you manufacture, such as Thymosin Beta-4. Products such as Thymosin Beta-4 are unapproved new drugs under section 505 of the FDCA [21 U.S.C. § 355(a)] and also biological products under section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. § 262]. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. Your biological products, such as Thymosin Beta-4, are not the subject of an approved BLA. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)].⁸

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.

You repackage drug products, such as Semaglutide, Tirzepatide, and Retatrutide, 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.

You manufacture other products, such as Thymosin Beta-4, 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 this product safely for their intended uses.

Accordingly, the labeling of these products fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.⁹

In addition, the strength of compounded products, specifically injectable Methylcobalamin 5,000 mcg/mL and injectable B12 Complex, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Because the labeling of these products is false, they are misbranded under section 502(a) of the FDCA.

The introduction or delivery for introduction into interstate commerce of the aforementioned products 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 report to FDA upon initial registration as an outsourcing facility in February 2025, and again in June 2025, identifying 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)].

D. Corrective Actions

We have reviewed your facility’s responses to the Form FDA 483. We acknowledge your firm has ceased drug production and distribution. We also acknowledge that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination.

Your corrective and preventive actions (CAPA) and supporting documentation, including the deviation investigations, specific procedures, implementation plans, or timelines to address the violations, are inadequate. These documents lack sufficient detail regarding the actions you are currently taking to address each specific violation within the observations, including but not limited to your failure to expand your investigations to related and deficient practices. Furthermore, you have not provided documentation of these changes, including but not limited to approved revisions, qualifications, validations, training, or other corrective action plans.

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).]

In addition, regarding issues related to the conditions of section 503B of the FDCA, we are unable to fully evaluate the following corrective actions due to lack of adequate supporting documentation:

1. You state that you are “conducting a comprehensive review of all product formulations to verify that all raw materials, including bulk drug substances, are consistent with the requirements under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” You also state that “any in-house drug products that contain bulk drug substances subject to evaluation will be segregated and quarantined pending determination of the appropriate disposition under regulatory requirements and internal procedures” and that “a formal procedure will also be developed to ensure that all drug products and bulk drug substances are verified against section 503B requirements on an ongoing basis.” However, you have not provided documentation regarding the disposition of drug products containing 5-amino-1MQ (5-amino-1-methylquinolinium iodide) and NAD+ (nicotinamide adenine dinucleotide) or evidence that you have ceased compounding these products.

2. While you acknowledge the importance of proper labeling and commit to developing procedures, your response lacks sufficient information. You have not provided a timeline for implementing corrective actions, stating only “TBD, depending on the timing of the (b)(4).” Additionally, you have not provided documentation demonstrating that your current labeling practices have been corrected.

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

1. Your SOP for adverse event reporting does not adequately address adverse event reporting. For example:

a. Your procedures do not adequately define what constitutes a “serious” adverse event;

b. Your procedures do not define what constitutes an “unexpected” adverse event; and

c. Your procedures do not adequately include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA.

2. You have not submitted any report to FDA identifying the drug products that you compounded during the previous 6-month period.

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 if you decide to resume production of drugs your management first 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.

If you decide to resume operations to produce drugs, 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 you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs. If you intend to resume production of drugs, please include an explanation of each step being taken to prevent the recurrence of any 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. In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs.

All correspondence should refer to the Warning Letter Number above (# 718739) 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

___________________

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 eligible for 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 outsourcing facilities registered 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 list where the drug product also does not appear 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 “503B Category 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 These 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 The products repackaged 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.

7 Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period.

8 Biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2018 guidance document, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action for certain violations of the FDCA when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. This guidance addresses the mixing, diluting, or repackaging of a licensed biological product, not a biological product licensed for further manufacturing use only or a bulk drug substance. The policies expressed in this guidance do not extend to any person or entity that mixes, dilutes, or repackages a biological product from any other starting material.

9 Your compounded, repackaged and manufactured 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).