Answers to Frequently Asked Questions About...
How to Get Emergency Contraception
What did the FDA say when making Plan B available without a prescription?
On August 24, 2006, Plan B was approved by the Food and Drug Administration (FDA) for nonprescription
sale to women and men 18 and older in the United States.
Read the Q&A about Plan B from the FDA and the Kaiser
Daily Women's Health Policy Report summaries of national media
coverage of the FDA's decision about Plan B. To read more about the contentious history of Plan B and the Bush Administration, click here.
At the FDA news conference following this
announcement, Dr. Steven Galson of the FDA answered reporters' questions
about the implementation of this FDA ruling about Plan B:
- Where can I buy Plan B?
- How does the FDA enforce the age restriction on Plan B?
- What if other people - parents, siblings, or friends - buy Plan B to give to women under the age of 18?
- Can men buy Plan B?
- What happens in pharmacy access states where women can already get Plan B without a doctor's prescription?
- Was the age restriction based on any scientific evidence that Plan B is not safe for women under 18?
Plan B is available only at pharmacies/stores staffed by a licensed pharmacist. To buy Plan B, you must present identification showing proof that you are at least 18 years old. Plan B will not be sold at gas stations or convenience stores, where other OTC products are routinely available. See the FDA's Q&A about Plan B [question 7a].
How will
the FDA enforce the age restriction barring women under the age of
18
from getting Plan B without a prescription?
According to the FDA, the manufacturer of Plan B, Barr Pharmaceuticals,
will take responsibility for making sure the age restrictions are
enforced. Plan B is only sold behind the counter in licensed
pharmacies, and it can only be sold when a pharmacist is on duty.
Barr will educate pharmacists about the age restriction, and proof
of age (in the form of any government-issued ID) will probably be required for purchase of Plan B. The FDA says that Barr
will monitor patterns of prescribing and will send test buyers to
pharmacies to try to buy Plan B to see whether these restrictions
are being enforced.
What if other
people - parents, siblings, or friends - buy Plan B to give to women
under the age of 18?
Dr. Galson said that the FDA is not in the business of regulating
the practice of medicine or individual people's behavior as regards
drug use. There are no restrictions against a person 18 or older buying
Plan B in advance to have on hand for future use. There are no
restrictions against a person 18 or older buying multiple packages
of Plan B at one time. Opponents of the age restriction have noted
that it will be much easier for young women to get an older friend
or relative to buy Plan B for them than to get a doctor's prescription
(and cheaper, too).
Can men buy
Plan B?
Yes - if they 18 or older. Men under the age of 18 will not be able
to buy Plan B either with or without a prescription. See the FDA's Q&A about Plan B [question 7b].
What happens
in the pharmacy access states where women can already get Plan B
without a doctor's prescription?
In 9 states (Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire,
New Mexico, Vermont, and Washington), legislation has been
passed allowing specially trained pharmacists to provide Plan B to
women without a doctor's prescription. In addition, a few pharmacists
in Montana provide Plan B under collaborative agreement with physicians.
Specific pharmacy practices are regulated from state to state. The
FDA ruling does not
change these existing pharmacy access programs unless those states
pass new legislation to change them. In pharmacy access states, women
under the age of 18 will still be able to obtain Plan B without a
doctor's prescription through specially trained and licensed pharmacists.
Click here for
more information about pharmacy access programs.
Was the age
restriction based on any scientific evidence that Plan B is not
safe
for women under 18?
Dr. Galson largely evaded reporters' questions about the age restriction on OTC availability of Plan B,
repeatedly referring them to the FDA website when they asked questions
about it. He said that the age restriction (which was originally set
at 16) was changed to 18 to make it less confusing for pharmacists to
enforce. Despite the FDA-imposed age restriction, there is good evidence
that easier access to ECPs (like Plan B) does not increase risk taking, either for
adults or adolescents.* The reviewing divisions at the FDA, the FDA
advisory committee, and multiple
major medical organizations — including the American
College of Obstetricians and Gynecologists, the American
Academy of Pediatrics 
,
and the Society for Adolescent
Medicine — support nonprescription access for Plan B, without
an age restriction.
*A thorough and up-to-date academic review of the medical and
social science literature on emergency contraception is available;
click here for the PDF .