C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

21 C.F.R. § 314.520

Approval with restrictions to assure safe use

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(a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as:

(1) Distribution restricted to certain facilities or physicians with special training or experience; or

(2) Distribution conditioned on the performance of specified medical procedures.

(b) The limitations imposed will be commensurate with the specific safety concerns presented by the drug product.

Notes of Decisions
Cited in 19 cases (5 in the last 5 years), 2009–2023 · leading case: Planned Parenthood Se. Ohio Region v. DeWine, 696 F.3d 490 (6th Cir. 2012).
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Planned Parenthood Se. Ohio Region v. DeWine, 696 F.3d 490 (6th Cir. 2012). · cites it 2× “at 188 (FDA Approval Letter at 2); 21 C.F.R. § 314.520 . Following FDA approval, additional clinical trials led to the development of new protocols for administering the drugs, one of which called for “200 mg of mifepristone administered orally followed one to three days later…”
Cordray v. Planned Parenthood Cincinnati Region, 2009 Ohio 2972 (Ohio 2009). · cites it 8× “” {¶ 6} Further, in its drug approval letter, the FDA, pursuant to 21 C.F.R. 314.520, imposed an additional restriction that mifepristone “be provided by or under the supervision of a physician who meets the following qualifications: {¶ 7} “[1.”
All. Hippocratic Med. v. FDA, 78 F.4th 210 (5th Cir. 2023). · cites it 2× “” 21 C.F.R. § 314.520 (emphasis omitted). Mifepristone was approved under § 314.”
Oklahoma Coalition for Reproductive Just. v. Cline, 2019 OK 33 (Okla. 2019). · cites it 3× “Specifically, the Code of Federal Regulations (CFR) provides for accelerated approval of certain drugs that are shown to be effective but "can be safely used only if distribution or use is restricted"; 3.”
Tummino v. Hamburg, 936 F. Supp. 2d 162 (E.D.N.Y 2013). · cites it 4× “Indeed, rather than rely on § 355(d), it argued that FDA regulations, specifically 21 C.F.R. § 314.520 , expressly authorized it to restrict distribution of Plan B to select pharmacies and health clinics.”
Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018). “11055; see 21 C.F.R. § 314.520 . During the regulatory review process for Xyrem ® , the FDA scheduled an advisory committee meeting for June 6, 2001.”
Planned Parenthood of Arizona v. William Humble, 753 F.3d 905 (9th Cir. 2014). “See 21 C.F.R. § 314.520 . These restrictions require the manufacturer to distribute mifepristone only to doctors who sign an agreement “stating that he or she possesses the necessary qualifications and will adhere to the other requirements.”
Cline v. Oklahoma Coalition for Reproductive Just., 313 P.3d 253 (Okla. 2013). “See 21 C.F.R. § 314.520 . Although the FDA required mifepristone's sponsor to distribute the drug only under conditions where it would be provided by or under the supervision of a physician who was able to meet certain criteria, the FDA did not go so far as to require that…”
Christison v. Biogen Idec Inc., 199 F. Supp. 3d 1315 (D. Utah 2016). “, under 21 CFR 314.520 and 601.42 “Approval with restrictions to assure safe use” or under 505-l(f)(3) of the *1324 Federal Food, Drug, and Cosmetic Act (FDCA) “Risk Evaluation and Mitigation Strategies” Elements to assure safe use).”
In re Actiq Sales & Mktg. Practices Litig., 307 F.R.D. 150 (E.D. Pa. 2015). “For a small class of prescription drugs, the FDA will grant approval under the distribution regulations of 21 C.F.R. § 314.520 (“Subpart H”), which is reserved for drug products that are effective but carry significant safety risks.”
Oklahoma Coalition for Reproductive Just. v. Cline, 368 P.3d 1278 (Okla. 2016). “The FDA approved mifepristone (brand name Mifeprex) under the rubric of 21 C.F.R., Section 314.520, also referred to as "Subpart H", which is the only FDA approval process that allows for postmarketing restrictions, Specifically, the Code of Federal Regulations (CFR) provides…”
Okla. Coal. for Reprod. Just. v. Cline, 441 P.3d 1145 (Okla. 2019). “The FDA approved mifepristone (brand name Mifeprex) under the rubric of 21 C.F.R., Section 314.520, also referred to as "Subpart H", which is the only FDA approval process that allows for postmarketing restrictions.”
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