The FDA Modernization Act of 1997

The Food and Drug Administration Modernization Act became law on November 21, 1997, as Public Law 105-115¹. FDA's own history of food and drug law³ says it “mandates the most wide-ranging reforms in agency practices since 1938.”

Most people who work with generic drugs meet the 1997 law through a single provision. Section 111 created the six months of pediatric exclusivity that still attaches to a brand drug when its maker studies it in children at FDA's request. FDA's running list of grants⁴ counted 354 pediatric exclusivity determinations as of its July 2026 update, covering 321 active moieties.

Its reach was far wider. It renewed the user fee program, created fast track, moved antibiotics into the main drug approval section of the statute, put “Rx only” on prescription labels, required early warning before certain drugs were discontinued and wrote the first federal rules for pharmacy compounding. Some pieces lasted, some expired and one was struck down by the Supreme Court. This history walks through the parts that matter for generics.

Six months for studying drugs in children

Under the new section 505A, if FDA issued a written request for pediatric studies and the sponsor completed them on time, the drug's existing protections grew by six months. The statute text¹ spelled out the arithmetic. Five years of new chemical entity exclusivity became five and a half; the four-year point at which a generic could file a patent challenge became four and a half; three-year exclusivity became three and a half; and seven years of orphan exclusivity became seven and a half. For a listed patent that a generic applicant had not defeated in court, FDA could not make the generic approval effective until six months after the patent expired.

Congress treated it as an experiment. A drug could earn the extra six months only if its application was submitted on or before January 1, 2002. The Best Pharmaceuticals for Children Act of 2002 carried the provision forward, FDA's milestones page³ notes, and in 2012 section 501 of the FDA Safety and Innovation Act⁷ struck the sunset altogether. FDA's pediatric labeling page⁵ tracks labeling changes since 1998 made under the children's drug act, the Pediatric Research Equity Act of 2003 and the 1998 Pediatric Rule, and the agency reports to Congress on the programs every five years, most recently for July 2020 through June 2025⁶. GxRadar's article on pediatric exclusivity covers how the six months play out for generics today.

User fees, fast track and faster reviews

Section 103 renewed the Prescription Drug User Fee Act for five more years, the reauthorization FDA calls PDUFA II⁸. The original 1992 fee law had authorized fees only through fiscal 1997.

Section 112 created fast track, a status for drugs that treat a serious condition and fill an unmet medical need. FDA's fast track page⁹ lists what it brings today, including more frequent meetings and written communication with the agency, and rolling review, under which a company can submit completed sections of its application before the whole thing is done. Section 113 required a federal information program on clinical trials for serious or life-threatening diseases, and section 116 rewrote how manufacturers report changes to an approved drug's production. Section 401 let companies share certain peer-reviewed articles about unapproved uses with doctors, under conditions, but the law set that authority to end on September 30, 2006, or seven years after FDA's implementing rules, whichever came later.

Antibiotics move into section 505

Before 1997, antibiotics had their own approval and certification track under section 507 of the Food, Drug, and Cosmetic Act. Section 125 of FDAMA repealed section 507. Antibiotic applications approved before the law took effect were treated from then on as new drug applications under section 505(b), or, if they had been abbreviated applications, as generic applications under section 505(j).

The move came with a carve-out. Drugs containing an antibiotic that had been the subject of any section 507 application received before enactment were excluded from the Hatch-Waxman patent listing, patent certification and exclusivity provisions. For a decade those older antibiotics sat partly outside the Orange Book system that governs other drugs. In 2008, the QI Program Supplemental Funding Act added a new section 505(v) that set conditions under which the patent and exclusivity provisions apply to drugs containing an antibiotic first submitted to FDA on or before November 20, 1997, according to an FDA notice published December 3, 2008¹⁰. The same notice set out deadlines of 60, 90 and 120 days after enactment for brand sponsors to submit patent information, for FDA to publish it and for pending generic applicants to certify to it.

“Rx only” and early warning on discontinuations

Section 126 rewrote the prescription legend. Under the 1997 text¹, a prescription drug is misbranded if, before dispensing, its label fails to bear “at a minimum, the symbol ‘Rx only’,” and a nonprescription drug is misbranded if its label does bear that symbol. GxRadar explains the marking in what “Rx only” means.

Section 131 created section 506C, an early warning rule that later became central to shortage tracking. A company that was the sole manufacturer of a drug that was life-supporting, life-sustaining or intended to prevent a debilitating disease had to notify FDA of a discontinuance at least six months ahead. The notice period could be shortened for good cause, including bankruptcy or economic hardship. In 2012, section 1001 of FDASIA⁷ rewrote 506C so that it reaches every manufacturer of such a drug, and so that it covers interruptions likely to lead to a meaningful disruption in supply as well as permanent discontinuances. GxRadar covers that change in FDASIA and early notice of shortages. On November 3, 2026, FDA's shortage list, which GxRadar reads through the openFDA shortage data¹³, showed 69 current shortages, 71 percent of them injectables.

The compounding section that did not survive intact

Section 127 added section 503A, the first federal statute written specifically for pharmacy compounding. A drug compounded by a licensed pharmacist or physician for an identified individual patient, based on the unsolicited receipt of a valid prescription, was exempt from FDA approval, from the label's adequate-directions requirement and from manufacturing quality rules, if it met a list of conditions. Among them were limits on advertising and promoting particular compounded drugs.

In 2002 the Supreme Court ruled¹² that “the FDAMA’s prohibitions on soliciting prescriptions for, and advertising, compounded drugs amount to unconstitutional restrictions on commercial speech.” The ruling left the validity of the rest of 503A in doubt until 2013. Congress acted after the 2012 outbreak tied to contaminated drugs from a Massachusetts compounding pharmacy, which FDA says caused more than 750 infections and more than 60 deaths in 20 states. The Drug Quality and Security Act, enacted November 27, 2013, removed the advertising provisions found unconstitutional and “removed uncertainty about the validity of section 503A,” according to FDA's compounding policy page¹¹. The same law created section 503B outsourcing facilities. See the Drug Quality and Security Act of 2013 and how 503A and 503B pharmacies differ.

Where the 1997 provisions stand

FDA keeps a page on the 1997 law² with background documents. The pediatric reward it started now has no end date, and the agency's list of exclusivity determinations was last refreshed in July 2026.