The 2020 OTC monograph reform, and what it has done so far

On Sept. 10, 2026, FDA removed two ingredients, aminobenzoic acid (PABA) and trolamine salicylate, from the list of active ingredients allowed in over-the-counter sunscreens sold without an approved application. The agency had first proposed the change in 2019, and it said it was not aware of any sunscreen then sold in the US that contained either one, according to FDA's sunscreen Q&A¹. Three months earlier, on June 10, FDA had added an ingredient, bemotrizinol, at concentrations up to 6 percent, in response to an industry request filed on Sept. 23, 2024, the Federal Register notice says².

Both actions ran through a process that did not exist before March 27, 2020. That day the CARES Act, the coronavirus relief law, added section 505G to the Food, Drug, and Cosmetic Act, FDA says³. It replaced the notice-and-comment rulemaking FDA had used for OTC monographs since the 1970s with administrative orders, created a user fee program to pay for the work, and set deadlines for sunscreens. This explainer covers what changed, what the fees are, and where the first big cases stand.

The system the CARES Act replaced

FDA began its Over-the-Counter Drug Review in 1972, according to the agency's history of food and drug law⁴. The review produced monographs, which FDA describes as a set of conditions, including "active ingredients, uses (indications), doses, routes of administration, labeling, and testing," under which an OTC drug in a therapeutic category such as sunscreen or antacid is generally recognized as safe and effective, or GRASE, on its monograph reform page³. A product that met its monograph could be sold without an approved application. The other route to the shelf, an approved application, is covered in GxRadar's explainer on prescription-to-OTC switches.

Before 2020 those monographs moved through formal rulemaking. Final monographs were codified in the Code of Federal Regulations, and GRASE conditions that were not yet final sat in proposed rules called tentative final monographs, FDA's rulemaking history page⁵ explains. When the CARES Act passed, some monographs were still at the proposed stage, in whole or in part, nearly five decades after the review began. Labeling did standardize along the way: a 1999 final rule required the uniform Drug Facts format on OTC labels, the FDA history notes, and its requirements sit in 21 CFR 201.66⁶.

What section 505G changed

Section 3851 of Public Law 116-136⁷ wrote the new framework, now codified at 21 U.S.C. 355h⁸. Its first move was to convert the old paperwork. A drug that met a final monograph, or a "category I" tentative final monograph, was deemed GRASE, and those monographs were deemed final administrative orders that FDA can amend through the new process. A drug classified in category II, or found not GRASE in the most recent proposal, was deemed a new drug that needs an approved application.

FDA's OTC drug review process page⁹ lays out the mechanics. Either FDA or a requestor can start an order. FDA issues a proposed order with at least 45 days for comment, then a final order, and every final order is open to formal dispute resolution, an administrative hearing and judicial review. For an imminent hazard, or a labeling change expected to reduce a serious risk, FDA can use an expedited procedure and issue an interim final order that takes effect before the public comments. When an order responds to an industry request, the statute can give the requester 18 months of marketing exclusivity, subject to limits, under 21 U.S.C. 355h(b)(5)⁸.

Section 3702 of the same law changed how OTC purchases are paid for. It made OTC medicines reimbursable from health savings accounts and flexible spending accounts without a prescription, for amounts paid after Dec. 31, 2019, the IRS said in 2020¹⁰; GxRadar's guide to using an HSA or FSA covers those accounts. A separate part of the CARES Act dealt with shortages, covered in GxRadar's piece on shortage reporting.

Who pays for the work

Congress also authorized, in the CARES Act, the Over-the-Counter Monograph Drug User Fee Program, known as OMUFA, which FDA describes as modeled on the prescription drug user fee program. Industry pays two kinds of fees: annual fees on facilities that make OTC monograph drugs, and a fee on each order request. The first authorization covered fiscal years 2021 through 2025, and a law signed Nov. 12, 2025, Public Law 119-37, renewed it for fiscal 2026 through 2030, FDA's OMUFA page¹¹ says. Products sold under an approved application owe no OMUFA facility fee.

By statute, the base order request fees were $500,000 for a Tier 1 request and $100,000 for a Tier 2 request, adjusted each year for inflation, under 21 U.S.C. 379j-72¹². Facility fees are set by dividing a target revenue figure by FDA's estimate of fee-paying facilities, with contract manufacturers counted at two-thirds. The table shows the arithmetic from FDA's notices for fiscal 2026¹³ and fiscal 2027¹⁴.

For fiscal 2027 the full facility fee is roughly two and a half times its fiscal 2026 level, because target revenue more than doubled while the estimated count of paying facilities fell. Fiscal 2027 facility fees are due in two halves, on Oct. 1, 2026, and Feb. 1, 2027, the OMUFA page says. FDA counts relabelers and repackagers as fee-liable facilities, the fiscal 2027 notice adds¹⁴, which touches the firms behind many store-brand OTC medicines. For comparison, GxRadar covers the generic drug fee program in its explainer on GDUFA.

Sunscreens, the first big test

Congress singled out sunscreens. The CARES Act created a deemed final order for them, built from a 1999 final monograph that had been stayed and a 2011 rule on labeling and effectiveness testing, and ordered FDA to propose a revised order within 18 months, by Sept. 27, 2021, FDA's sunscreen Q&A¹ says. FDA posted both on Sept. 24, 2021.

Those two documents are far apart. The deemed order treats sunscreens with any of 16 active ingredients as GRASE and sets no maximum SPF. The 2021 proposal would find only zinc oxide and titanium dioxide GRASE, would find PABA and trolamine salicylate not GRASE on safety grounds, and would ask for more data on the other 12, including oxybenzone and avobenzone. It would also cap labeled SPF at "60+" and require broad-spectrum protection for products at SPF 15 and above. FDA received more than 15,000 comments, many needing extensive scientific review, and has chosen to finalize the proposal in pieces.

Dates come from the Q&A and the bemotrizinol² and PABA¹⁵ Federal Register notices. Under the CARES Act, a final sunscreen order cannot take effect earlier than one year after it is issued. Labeling, dosage forms and maximum SPF remain open and will be handled in future orders, FDA says. GxRadar's article on benzene in consumer drug products covers a separate sunscreen quality issue.

Oral phenylephrine and what is still pending

One closely watched order that FDA started on its own concerns a cold medicine ingredient. On Nov. 7, 2024, FDA proposed removing oral phenylephrine as an active ingredient for nasal decongestion after concluding it is not effective for that use, the agency announced¹⁶; a notice followed in the Federal Register on Nov. 8¹⁷. FDA said "the proposed order is based on effectiveness concerns, not on safety concerns," that an advisory committee had unanimously reached the same view in 2023, and that "only a final order will affect what products can be marketed."

GxRadar found no Federal Register notice of a final phenylephrine order in a search of FDA notices through Nov. 4, 2026. When it made the proposal, FDA said companies may continue to market products containing oral phenylephrine until a final order says otherwise. Questions about a specific cold or allergy product are for a pharmacist.

The next fixed dates are financial and legal. The second half of fiscal 2027 OMUFA facility fees is due Feb. 1, 2027, and the PABA and trolamine salicylate order cannot take effect before September 2027, a year after its issuance.