C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 310—NEW DRUGS › Subpart E—Requirements for Specific New Drugs or Devices

21 C.F.R. § 310.501

Patient package inserts for oral contraceptives

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(a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient (or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either). The patient package insert is required to be placed in or accompany each package dispensed to the patient.

(b) Distribution requirements. (1) For oral contraceptive drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient.

(2) Patient package inserts for oral contraceptives dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first oral contraceptive and every 30 days thereafter, as long as the therapy continues.

(c) Contents of patient package insert. A patient package insert for an oral contraceptive drug product is required to contain the following:

(1) The name of the drug.

(2) A summary including a statement concerning the effectiveness of oral contraceptives in preventing pregnancy, the contraindications to the drug's use, and a statement of the risks and benefits associated with the drug's use.

(3) A statement comparing the effectiveness of oral contraceptives to other methods of contraception.

(4) A boxed warning concerning the increased risks associated with cigarette smoking and oral contraceptive use.

(5) A discussion of the contraindications to use, including information that the patient should provide to the prescriber before taking the drug.

(6) A statement of medical conditions that are not contraindications to use but deserve special consideration in connection with oral contraceptive use and about which the patient should inform the prescriber.

(7) A warning regarding the most serious side effects of oral contraceptives.

(8) A statement of other serious adverse reactions and potential safety hazards that may result from the use of oral contraceptives.

(9) A statement concerning common, but less serious side effects which may help the patient evaluate the benefits and risks from the use of oral contraceptives.

(10) Information on precautions the patients should observe while taking oral contraceptives, including the following:

(i) A statement of risks to the mother and unborn child from the use of oral contraceptives before or during early pregnancy;

(ii) A statement concerning excretion of the drug in human milk and associated risks to the nursing infant;

(iii) A statement about laboratory tests which may be affected by oral contraceptives; and

(iv) A statement that identifies activities and drugs, foods, or other substances the patient should avoid because of their interactions with oral contraceptives.

(11) Information about how to take oral contraceptives properly, including information about what to do if the patient forgets to take the product, information about becoming pregnant after discontinuing use of the drug, a statement that the drug product has been prescribed for the use of the patient and should not be used for other conditions or given to others, and a statement that the patient's pharmacist or practitioner has a more technical leaflet about the drug product that the patient may ask to review.

(12) A statement of the possible benefits associated with oral contraceptive use.

(13) The following information about the drug product and the patient package insert:

(i) The name and place of business of the manufacturer, packer, or distributor, or the name and place of business of the dispenser of the product.

(ii) The date, identified as such, of the most recent revision of the patient package insert placed prominently immediately after the last section of the labeling.

(d) Other indications. The patient package insert may identify indications in addition to contraception that are identified in the professional labeling for the drug product.

(e) Labeling guidance texts. The Food and Drug Administration issues informal labeling guidance texts under § 10.90(b)(9) of this chapter to provide assistance in meeting the requirements of this section. A request for a copy of the guidance texts should be directed to the Center for Drug Evaluation and Research, Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.

(f) Requirement to supplement approved application. Holders of approved applications for oral contraceptive drug products that are subject to the requirements of this section are required to submit supplements under § 314.70(c) of this chapter to provide for the labeling required by this section. Such labeling may be put into use without advance approval by the Food and Drug Administration.

[54 FR 22587, May 25, 1989, as amended at 74 FR 13113, Mar. 26, 2009]
Notes of Decisions
Cited in 24 cases, 1979–2004 · leading case: MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65 (Mass. 1985).
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MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65 (Mass. 1985). · cites it 6× “9002 -9003 (1970), recodified at 21 C.F.R. § 310.501 (a)(4), 39 Fed. Reg. 11680 (1974), 40 Fed.”
Kurer v. Parke, Davis & Co., 2004 WI App 74 (Wis. Ct. App. 2004). · cites it 5× “associated with the drug's use," 21 C.F.R. § 310.501 (c)(2), of "the most serious side effects," § 310.”
Humes v. Clinton, 792 P.2d 1032 (Kan. 1990). · cites it 3× “The court examined 21 C.F.R. § 310.501 (1989), a federal regulation governing oral contraceptives, and determined the reason for requiring patient labels was to make patients more sensitive to possible side effects of the drug.”
In Re Certified Questions, 358 N.W.2d 873 (Mich. 1984). · cites it 5× “Ortho also published and distributed to Odgers' physician a booklet discussing in layperson's language the proper use of the drug and the potential risks associated with that use, in compliance with a federal Food and Drug Administration regulation as it then was written, 21 CFR…”
Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541 (Ind. Ct. App. 1979). · cites it 2× “[7] Section 388 states: Chattel Known to be Dangerous for Intended Use One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be…”
Lukaszewicz v. Ortho Pharm. Corp., 532 F. Supp. 211 (E.D. Wis. 1981). · cites it 5× “961 , of which footnote 2 was amended in an order issued April 28, 1981, the Court held that the defendant had a duty to warn patients directly, and not merely their physicians, of the possible side effects of Ortho-Novum in the manner provided in 21 C.F.R. § 310.501 . At pages…”
Odgers v. Ortho Pharm. Corp., 609 F. Supp. 867 (E.D. Mich. 1985). · cites it 3× “argues that the FDA’s exhaustive requirements regarding package inserts for oral contraceptives, see 21 C.F.R. § 310.501 , as a practical matter make it impossible to deviate from these requirements in order to conform to a common law duty to warn.”
Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 961 (E.D. Wis. 1981). · cites it 3× “Syntex Laboratories, supra, but without specific discussion none of them have used 21 C.F.R. § 310.501 to impose on a manufacturer of oral contraceptives a duty to warn the patient as well as the doctor, a breach of which would give rise to strict liability in tort to the…”
Edwards v. Basel Pharm., 933 P.2d 298 (Okla. 1997). · cites it 2× “We see no reason that this second exception should not apply to nicotine patches available by prescription. When direct warnings to the user of a prescription drug have been mandated by a safety regulation promulgated for the protection of the user, an exception to the learned…”
West v. G.D. Searle & Co., 879 S.W.2d 412 (Ark. 1994). · cites it 4× “See 21 C.F.R. § 310.501 (a)-(c) (1993). This was the requirement at the time Gari West was taking the contraceptives.”
Elizabeth L. Henley v. Food & Drug Admin., Dep't of Health & Human Servs. Kessler, Dr., Comm'r of Food & Drug United States, 77 F.3d 616 (2d Cir. 1996). · cites it 2× “” 21 C.F.R. § 310.501 (1989). In 1989, after notice and comment proceedings, the FDA revised the requirements for patient package inserts for oral contraceptives (the “1989 Ruling”).”
Seley v. G. D. Searle & Co., 423 N.E.2d 831 (Ohio 1981). “21 C.F.R. Section 310.501. See, also, 2 Restatement of Torts 2d 135, Section 323: “One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person, or things, is subject to…”
Show all 24 citing cases →
— 21 C.F.R. § 310.501(a) — 3 cases
Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541 (Ind. Ct. App. 1979). “[7] Section 388 states: Chattel Known to be Dangerous for Intended Use One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be…”
Ortho Pharm. Corp. v. Chapman, 180 Ind. App. 33 (Ind. Ct. App. 1979).
Elizabeth L. Henley v. Food & Drug Admin., Dep't of Health & Human Servs. Kessler, Dr., Comm'r of Food & Drug United States, 77 F.3d 616 (2d Cir. 1996). “” 21 C.F.R. § 310.501 (1989). In 1989, after notice and comment proceedings, the FDA revised the requirements for patient package inserts for oral contraceptives (the “1989 Ruling”).”
— 21 C.F.R. § 310.501(a)(1) — 2 cases
In Re Certified Questions, 358 N.W.2d 873 (Mich. 1984). “Ortho also published and distributed to Odgers' physician a booklet discussing in layperson's language the proper use of the drug and the potential risks associated with that use, in compliance with a federal Food and Drug Administration regulation as it then was written, 21 CFR…”
Odgers v. Ortho Pharm. Corp., 419 Mich. 686 (Mich. 1984).
— 21 C.F.R. § 310.501(a)(6) — 2 cases
In Re Certified Questions, 358 N.W.2d 873 (Mich. 1984). “Ortho also published and distributed to Odgers' physician a booklet discussing in layperson's language the proper use of the drug and the potential risks associated with that use, in compliance with a federal Food and Drug Administration regulation as it then was written, 21 CFR…”
Odgers v. Ortho Pharm. Corp., 419 Mich. 686 (Mich. 1984).
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