WARNING LETTER
Chemco Corporation
MARCS-CMS 721592 —
April 07, 2026
Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
320-26-60
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Eitelberg G. Montarroyos, Sr.
Recipient Title
Chief Executive Officer
Chemco Corporation
4920 NW 165th Street
Miami Lakes
,
FL
33014-6323
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-26-60
April 7, 2026
Dear Mr. Montarroyos:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemco Corporation, FEI 1042599, at 4920 NW 165th St., Miami Lakes, from August 11 to 22, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
In addition, your “PRO Nail FUNGUS KILLER” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). This product is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).
Separately, "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells," "Eternal Spirit Beauty PAINLESS Pain relieving cream," and "Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes" drug products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), while the “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” and “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT” drug products are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(a). Subsequently, these products are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).
Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
We reviewed your September 12, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
CGMP Violations
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)).
You manufacture topical, over-the-counter (OTC), non-sterile drug products. You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your drug products.
Inadequate Equipment Cleaning
During the inspection, our investigator observed white residue in a piece of manufacturing equipment (Tank #68) that your quality unit verified as clean according to your
(b)(4)
tank cleaning logbook. This equipment was previously used in the manufacture of a topical drug product containing
(b)(4)
.
Lack of Cleaning Validation
During the inspection, you stated that you had not conducted cleaning validation studies for your non-dedicated equipment. You use active ingredients such as
(b)(4)
in your drug products. You failed to demonstrate that your cleaning process is effective in preventing cross-contamination between the various drug products manufactured on the same equipment.
In your response, you state that you will use
(b)(4)
analysis to verify the effectiveness of cleaning activities performed on your manufacturing equipment. Your response is inadequate because you did not provide evidence that your cleaning methods are appropriate and effective in removing contaminants, such as drug product residues, cleaning and sanitizing agents, and objectionable organisms. Furthermore, you did not assess the impact of your inadequate cleaning processes on drug products that are currently on the market and within expiry.
In response to this letter, provide the following:
A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment of whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one drug product.
A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all drug products and equipment; and all other needed remediations.
Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
o drugs with higher toxicities
o drugs with higher drug potencies
o drugs of lower solubility in their cleaning solvents
o drugs with characteristics that make them difficult to clean
o swabbing locations for areas that are most difficult to clean
o maximum hold times before cleaning
In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.
A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).
You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products, such as
(b)(4)
.
Identity testing of high-risk drug components (e.g.,
(b)(4)
) includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for
(b)(4)
levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.
In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.
(b)(4)
You failed to adequately test each shipment of each lot of
(b)(4)
for
(b)(4)
contamination.
The use of ingredients contaminated with
(b)(4)
has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
(b)(4)
to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for
(b)(4)
contamination at
(b)(4)
.
(b)(4)
You failed to adequately test your incoming
(b)(4)
for
(b)(4)
. The use of
(b)(4)
contaminated with
(b)(4)
has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
(b)(4)
.
In your response, you state that you will install and qualify new laboratory equipment to perform all required testing and will send components to a third-party laboratory for analysis in the interim. Your response is inadequate because you did not consider retrospective identity testing, or assessment by other methods, of reserve samples of the components used in your drug products that remain in the market and are within expiry. Additionally, your response lacks details on the remediation of your supplier qualification program.
Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.
In response to this letter, provide the following:
A comprehensive, independent review of your material system, including but not limited to:
o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;
o an assessment of all materials to determine whether they are consistently of acceptable quality;
o a review to ensure assigned expiration or retest dates are appropriate (supported by data)
o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.
Based on a thorough review, provide a summary of your systemic CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.
The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
A commitment to provide
(b)(4)
test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, test retain samples of all implicated finished drug product batches for the presence of
(b)(4)
.
A full risk assessment for drug products that are within expiry which contain any ingredient at risk for
(b)(4)
contamination (including, but not limited to,
(b)(4)
). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain
(b)(4)
including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPAs that secure supply chains in the future including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:
Adequate investigations into out-of-specification (OOS) results that include scientific justification for the purported root cause and an assessment of impact to other batches and drug products.
Adequate written procedures for production and process control (e.g., process validation).
Your firm’s quality systems are inadequate. See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.
In your response, you state that for process validation you will establish a robust validation program and will validate the manufacturing processes used in the production of your drug products. However, you did not address the issue of inadequate investigations.
Your response is inadequate because it does not address remediation to your investigation procedures. Additionally, your response does not provide a timeframe for completion of process validation activities for each of your drug products, nor does it provide your interim plan for any drugs distributed before validation activities are completed to ensure you produce drug products of acceptable quality.
In response to this letter, provide:
A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.
A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.
Process performance protocol(s), and written procedures for qualification of equipment and facilities.
A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
Repeat Violations at Facility
In a previous inspection, conducted in October 2022, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your responses. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate. For example, during the regulatory meeting held with your firm on June 16, 2023, we discussed that you failed to adequately validate the manufacturing processes used in the production of your drug products. After the meeting, you committed to correcting this deficiency. However, during the current inspection, the same deficiency was observed.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements.
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Unapproved New Drugs and Misbranded Drug Violations
“PRO Nail FUNGUS KILLER,” “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT,” “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Examples from product labeling, including your websites, www.echemco.com and www.beautymarketonline.com, that provide evidence of intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
PRO Nail FUNGUS KILLER
“maximum strength Antifungal Solution with Undecylenic Acid 25%, Eliminates fungus on fingers & toes” [from principal display panel on product label]
“Helps stop and eliminate fungal infections on cuticles, skin around nail edges and under nail tips where accessible with applicator drops.” [from side panel on product label]
“
Uses
▪ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ▪ Relieves itching, scaling, cracking, burning and redness.” [from drug facts panel on product label]
“
Maximum Strength Fungus Killer Liquid – Antifungal Treatment
with Undecylenic Acid, Vitamin E & Tea Tree – Treats Toe Nail Fungi, Athlete’s Foot, Ringworm, and Jock Itch” [from sidebar ad on product website page at https://beautymarketonline.com/products/pronail-maximum-strength-fungus-killer?variant=45535349440739]
SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY and ICY MINT
“…ANTISEPTIC Protects Against Bacteria Reducing the Risk of Skin Infection with Each Use…” [from principal display panel on product label]
“
Uses
First aid to help protect against bacterial contamination.” [from drug facts panel on product label]
Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells
“
Use
Help prevent recurrence of flaking and itching associated with dandruff.” [from drug facts panel on product label]
Eternal Spirit Beauty PAINLESS Pain relieving cream
“
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.” [from drug facts panel on product label]
Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes
“
Uses
▪ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ▪ Relieves itching, scaling, cracking, burning and redness.” [from drug facts panel on product label]
Unapproved New Drug Violations
Based on the above labeling evidence, “PRO Nail FUNGUS KILLER” is intended for use as an over-the-counter (OTC) topical antifungal drug product. As described below, this OTC drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product.
1
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements.
PRO Nail FUNGUS KILLER
Your “PRO Nail FUNGUS KILLER” is a topical antifungal drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this product falls under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has concluded, in a final determination issued under 21 CFR part 330, that topical antifungal drug products labeled with claims or directions for use on the scalp or nails are not GRASE.
2
This is evidenced by the product labeling that states “helps stop and eliminate fungal infections . . . under nail tips where accessible with applicator drops” and the image on the principal display panel (PDP) of the dropper dispensing the drug directly on the nail. Thus, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), for which no FDA-approved application pursuant to section 505 of the FD&C Act is in effect. Therefore, this product is an unapproved new drug.
The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Your “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” drug products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labeling includes statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. For example, all three product labels include the statement “made in an FDA registered facility.” FDA’s regulations provide that “[r]egistration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed” (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA’s regulations. The above assertions misleadingly suggest that the above-mentioned drug products are approved or endorsed by FDA in some way. Your “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” drug products are not the subjects of an FDA-approved application. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.
Additionally, "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells" is further misbranded under section 502(a) because it prominently features "Now With Stem Cells" on the label’s PDP. Under 21 CFR 201.10(c)(4), "[t]he labeling of a drug may be misleading by reason ... [of] [t]he featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation." The labeling for "Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells" prominently features stem cells on the PDP including within the product name. Featuring this inactive ingredient prominently on the PDP creates an impression of value greater than its functional role in the formulation and thus causes this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
The product labels for "SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY" and "SPA REDI Gelle-n-Detox Massage Lotion ICY MINT" are not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66. Specifically, the products’ labels fail to include the statement “in minor cuts, scrapes, and burns” within the Uses section of Drug Facts as required under M003.50(b) within the Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for OTC Human Use. Therefore, these products are misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Subsequently, “PRO Nail FUNGUS KILLER,” “SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY,” “SPA REDI Gelle-n-Detox Massage Lotion ICY MINT,” “Eternal Spirit Beauty HAIR PRO Anti-Dandruff, Now With Stem Cells,” “Eternal Spirit Beauty PAINLESS Pain relieving cream,” and “Eternal Spirit Beauty FUNGI FRESH Anti-fungus Liquid for Fingers & Toes” are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and/or are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Cosmetics Manufactured for Distribution in the United States
In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.
We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist 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.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1042599 and ATTN: CDR Frank Verni.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
/S/
Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
_________________
1
FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your “PRO Nail FUNGUS KILLER” drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.
2
On September 2, 1993, FDA issued a final rule establishing that certain labeling claims for OTC topical antifungal drug products, including for use on scalp or on the nails, are not generally recognized as safe and effective. 58 Fed. Reg. 46744. FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(22)(iii). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs;" notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330 prior to enactment of the CARES Act. In the case of first aid antiseptic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for OTC Human Use. See Order ID OTC000030, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)
Content current as of:
04/14/2026
Regulated Product(s)
Drugs
Over-the-Counter Drugs