About OTC Monograph Reform
On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In addition to the COVID-19 response efforts, the CARES Act includes statutory provisions that reform and modernize the way OTC monograph drugs are regulated in the United States. Specifically, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. The CARES Act also provides FDA the authority to assess and collect user fees dedicated to OTC monograph drug activities. FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
In support of the law, the Over the Counter Monograph User Fees Program Performance Goals and Procedures document was drafted to specify FDA and industry mutually agreed upon timelines. [Note: Dates of commitments will be updated to reflect the date of passage of the legislation.]
OTC [email protected] will provide the public with the ability to search for proposed and final administrative orders that add, remove or change conditions for an OTC drug monograph. OTC [email protected] will also provide the public with an opportunity to submit comments and data to proposed administrative orders.
FDA anticipates OTC [email protected] to available to the public in fiscal year 2021.
Frequently Asked Questions, by topic
An OTC monograph drug is a nonprescription, over-the-counter (or OTC) drug that may be marketed without an approved drug application under section 505 of the FD&C Act if it meets the requirements of section 505G of the FD&C Act, as well as other applicable requirements.
Simply stated, an OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, route of administration, labeling, and testing under which an OTC drug is generally recognized as safe and effective (GRASE).
In 1972, FDA established the Over the Counter (OTC) Drug Review to evaluate the safety and effectiveness of nonprescription, OTC drug products marketed in the United States before May 11, 1972. The OTC Drug Review established conditions under which OTC drugs were generally recognized as safe and effective (GRASE) and not misbranded. These GRASE conditions were described in OTC drug monographs for each OTC therapeutic drug class. Prior to enactment of the CARES Act, the OTC Drug Review relied on a three-phase public rulemaking process to establish monographs.
For more information on the OTC Drug Review prior to enactment of the CARES Act, see the FDA webinar titled Monograph reform is here! Learn what to expect and how to prepare.
The CARES Act, enacted on March 27, 2020, includes important reforms that modernize the way OTC monograph drugs are regulated in the United States. Specifically, the CARES Act replaces the rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. The CARES Act also provides FDA the authority to assess and collect user fees dedicated to OTC monograph drug activities. FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
Despite FDA’s successes in providing consumers with access to a wide variety of safe and effective OTC monograph drugs, challenges with the nearly 50-year old OTC Drug Review process became apparent. The biggest challenges of the OTC Drug Review prior to the CARES Act included:
- Burdensome, multistep rulemakings to establish or amend monographs;
- FDA lacked adequate resources to devote to rulemaking process;
- Delays in finalizing monographs;
- Limited, burdensome process for innovation (e.g., new combinations of ingredients or new dosage forms);
- Delays in responding to safety issues; and
- Challenges in keeping pace with evolving science and changing market conditions.
OTC Monograph Reform is expected to accomplish the following:
- Improve the process by replacing rulemaking with administrative orders;
- Improve efficiency, timeliness, and predictability;
- Facilitate innovation;
- Establish a process to rapidly address safety issues;
- Finalize pending monographs; and
- Provide FDA with user fees to support OTC monograph drug activities.
Are there timelines and performance goals for OTC Monograph Reform under the CARES Act?
Yes, the Over-the-Counter Monograph User Fee Program Performance Goals and Procedures document outlines the performance and procedural goals and other commitments agreed to by the agency for purposes of this user fee program. These goals apply to aspects of the over-the-counter monograph drug review program that are important for facilitating timely access to safe and effective medicines regulated under the OTC drug monograph system, and to implementing the OTC monograph policy reforms.
During the first three years of OTC Monograph Reform, essentially all effective review capacity is expected to be consumed by current external mandates, safety activities, and OTC Monograph Reform implementation and infrastructure development activities. Beginning in Years 4 and 5 (and to a limited extent in Year 3), FDA expects to have built sufficient effective review capacity to begin to have timelines and performance goals for review activities expected to be part of the steady state of a monograph review program.
FDA is committed to meeting the timelines and performance goals and to continuous improvement of its performance.
Administrative Orders and OTC Monograph Order Requests (OMOR)
The CARES Act gives FDA the authority to issue an administrative order that adds, removes or changes GRASE conditions for an OTC drug monograph.
Either industry or FDA can initiate the administrative order process. A request by industry to initiate the administrative order process is called an OTC Monograph Order Request (OMOR) and can be made by a requestor, which is defined in the CARES Act as any person or group of persons marketing, manufacturing, processing, or developing a drug.
As FDA issues each proposed or final administrative order, FDA will publish the order on FDA’s public website. Additionally, FDA will also publish a notice of availability of each proposed and final administrative order in the Federal Register.
Yes. After issuance of a proposed administrative order, there will be a public comment period. The public will receive at least 45 calendar days (and potentially longer depending on the subject of the proposed order) to submit comments on the proposed administrative order. When FDA issues the proposed order, the agency will provide Information on how the public should submit their comments and the duration of the comment period.
The procedure for FDA to initiate an administrative order can be expedited when FDA determines:
- a drug poses an imminent hazard to public health; or
- a change in the labeling of a drug, class of drugs, or combination of drugs is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.
The term ‘‘OTC monograph order request’’ (or OMOR) is defined in section 744L(7) of the FD&C Act and refers to a request for FDA to issue an administrative order under section 505G of the FD&C Act.
There are two types of OMORs: Tier 1 and Tier 2.
As described in section 744L(8) of the FD&C Act, a Tier 1 OMOR is any request not determined to be a Tier 2 OMOR.
Examples of Tier 1 OMORs include additions of:
- A new ingredient to a monograph that already has one or more ingredients that have been found to be GRASE.
- A new indication to a monograph that already has one or more ingredients that have been found to be GRASE, and the new indication applies to one or more of the GRASE ingredients.
- New monograph therapeutic category (each ingredient proposed for the new therapeutic category will be a separate OMOR).
As described in section 744L(9) of the FD&C Act, a Tier 2 OMOR is a request for:
- Reordering of existing information in the drug facts label of an OTC monograph drug;
- Addition of information to the “Other Information” section of the drug facts label of an OTC monograph drug (subject to certain limitations);
- Modification to the “Directions for Use” section of the drug facts label of an OTC monograph drug, consistent with a minor dosage form change;
- Standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
- Change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
- Addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).
Based on program implementation experience or other factors found appropriate by FDA, FDA may also characterize any OMOR as a Tier 2 OMOR (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 505G of the FD&C Act.
FY 2021 Facility User Fee Rates
Facility fees will be published in a Federal Register notice
FY 2021 OMOR Fee Rates
The facility fee will be assessed for qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.
The OTC Monograph User Fee program does not assess a facility fee for human OTC drug products that are produced under an approved drug application. The Federal Register Notice referenced above will provide more information about FY 2021 facility fees.
The facility fee is due annually.
Under section 744L of the FD&C Act, an OTC monograph drug facility is generally defined as a foreign or domestic business or other entity that:
- is under one management, either direct or indirect, and at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
- includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
- does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies; testing; or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
As defined in section 744L of the FD&C Act, a CMO facility is an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
Yes, a qualifying CMO facility pays a fee equal to two-thirds of the amount of the fee for a qualifying OTC monograph drug facility that is not a CMO facility.
As described in section 744M(a) of the FD&C Act, beginning with fiscal year 2021, each person that submits an OMOR is subject to an OMOR fee upon submission of the OMOR. However, a person that submits an OMOR shall not be subject to an OMOR fee if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—
(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
FDA will develop guidance regarding formal meetings between FDA and sponsors or requestors of OMORs, as required by section 505G(l) of the FD&C Act. Prior to publication of that guidance, submit meeting requests to [email protected]. FDA anticipates such guidance will include guidance on the content of a meeting package for formal meetings between FDA and sponsors or requestors of OMORs. Prior to publication of this guidance, meeting requestors can refer to the guidance for industry Formal Meetings Between the FDA and Sponsors and Applicants of PDUFA Products. Meeting package content questions that are not covered in this guidance can be addressed to [email protected].
Additional information on the types of meetings and overall process for meetings can be found in the Over-the-Counter Monograph User Fee Program Performance Goals and Procedures document.
Status of Existing OTC Monograph Products
Before the enactment of the Coronavirus Aid, Relief, and Economic Security Act (or the “CARES Act”) on March 27, 2020, the OTC Drug Review was a rulemaking process. As part of that process, FDA issued tentative final monographs (TFMs) in proposed rules and final OTC drug monographs in final rules. The TFMs categorized active ingredients and other OTC conditions into three different categories for safety and effectiveness: Category I for conditions FDA proposed were generally recognized as safe and effective (GRASE), Category II for conditions FDA proposed were not GRASE, and Category III for conditions that had insufficient data for FDA to propose if they were GRASE. The categories are not used in final monographs. Only active ingredients and other conditions determined by FDA to be GRASE are included in final OTC drug monographs.
No. A drug that is classified in Category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not GRASE in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21 CFR is deemed a new drug under section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is misbranded under section 502(ee) of the FD&C Act, and is subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act beginning on September 23, 2020. The Secretary has not determined that it is in the interest of public health to extend the period during which any Category II drug may be marketed without such an approved new drug application (NDA).
“[a] drug that is classified as category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21 of the Code of Federal Regulations, shall be deemed to be a new drug under section 201(p), misbranded under 502(ee), and subject to the requirement for an approved new drug application under section 505 beginning on the day that is 180 calendar days after the date of the enactment of this section, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application.”
Therefore, under the CARES Act, drugs that are classified in Category II for safety or effectiveness in a TFM or determined to not be GRASE in the most recently applicable proposed rule are deemed to be new drugs and misbranded, and cannot be marketed without an approved drug application beginning on September 23, 2020. The Secretary has not determined that it is in the interest of public health to extend the period during which any Category II drug may be marketed without such an approved new drug application (NDA).
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