[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.501]

[Page 20-22]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 310_NEW DRUGS--Table of Contents
 
        Subpart E_Requirements for Specific New Drugs or Devices
 
Sec. 310.501  Patient package inserts for oral contraceptives.


    (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.

[[Page 21]]

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.

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    (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 Sec. 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 Metabolism and 
Endocrine Drug Products (HFD-510), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.
    (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 Sec. 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]