Plan B Available Over-the-Counter for Women 18 and Older

[Pony]

The FDA has approved Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women ages 18 and older. Plan B is often referred to as emergency contraception, or the "morning after pill." It contains an ingredient used in prescription birth control pills—only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen.

Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B, approved in August, will remain available as a prescription-only product for women ages 17 and younger.

Duramed Pharmaceuticals Inc. of Pomona, N.Y., a subsidiary of Barr Pharmaceuticals Inc., will make Plan B available with a rigorous labeling, packaging, education, distribution, and monitoring program. In the CARE (Convenient Access, Responsible Education) program, Duramed commits to providing consumers and health care professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B ensuring that distribution of Plan B will be only through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription, designing packaging to hold both OTC and prescription Plan B.

Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age monitoring the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and older and prescription Plan B to women younger than 18.

For More Information: http://www.fda.gov/cder/drug/infopage/planB/

[CoolAunt]

I don't understand. I thought that over-the-counter meant without a prescription.

[Pony]

Cool Aunt I am trying to get an answer about that. Either it's wrong, or it's badly written, or it's wrong, or...

Just an example of how careless the whole women's issues initiative is at the FDA (and Health Canada, NHS, TGA).

[Andrew]

Sounds like it is OTC only if you are 18 or older. THerefore it has to be kept behind the counter because you would either need;
a) proof of age (over 18)
or
b) a prescription (under 18)

[Pony]

I haven't seen any news stories on it. Have you?

[SharkBait]

That was how it read to me Andrew.

[Pony]

At the time Plan B became available to women in Canada, with or without a prescription but in both cases, behind the pharmacy wall, the Canadian Medical Journal sent out a phalanx of women to 'test' the delivery of this product. I wonder if something similar could be done in the States.

[Andrew]

I don't know how those emoticons got in my post. THat should be: (over 18) and (under 18). Sorry!