Answers to Frequently Asked Questions About...
Emergency Contraception Over the Counter
Q&A About OTC Access to Emergency Contraception (EC)
Where can Emergency Contraception be sold over the counter (OTC)?
Emergency contraceptive pills, like Plan B One-Step and Next Choice, can be sold only at the pharmacy counter. Because emergency contraceptives have a "dual label" in the United States, it is OTC for consumers 17 and older but only available by prescription to women under 17. Plan B One-Step and Next Choice are available only in retail outlets that have a pharmacy with licensed professionals. EC is not available in places that do not have a licensed prescriber or pharmacist on site - such as gas stations or convenience stores - nor is it likely to be available for purchase if a licensed pharmacist is off duty.
Can pharmacies provide EC to girls under 17 years old?
Over the counter (OTC) access is limited to women and men 17 and older. However, pharmacists can fill a prescription for women of any age and, in most states where pharmacists have prescriptive authority, there is no age restriction for dispensing EC.
Can pharmacies sell EC to a man? An older sister of a 16 year-old? A woman who is buying it “just in case”?
Yes. The FDA does not specify that the product must be sold to the intended user. The only requirements are that the purchaser is 17 or older and can show proof of age.
What are acceptable forms of proof of age for purchase of EC?
According to the agreement between Barr and the FDA, any government-issued identification is sufficient for proof of age. Examples of government-issued identification include but are not limited to:
- United States passport (unexpired or expired).
- Alien Registration Receipt Card or Permanent Resident Card, Form I-551.
- An unexpired foreign passport that contains a temporary I-551 stamp.
- An unexpired Employment Authorization Document issued by the Immigration and Naturalization Service which contains a photograph, Form I-766; Form I-688, Form I-688A, or Form I-688B.
- In the case of a nonimmigrant alien authorized to work for a specific employer incident to status, an unexpired foreign passport with an Arrival-Departure Record, Form I-94, bearing the same name as the passport and containing an endorsement of the alien's nonimmigrant status, so long as the period of endorsement has not yet expired and the proposed employment is not in conflict with any restrictions or limitations identified on the Form I-94.
- A driver's license or identification card containing a photograph, issued by a state or an outlying possession of the United States. If the driver's license or identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address.
- School identification card with a photograph.
- Voter registration card.
- U.S. military card or draft record.
- Identification card issued by Federal, State, or local government agencies or entities. If the identification card does not contain a photograph, identifying information shall be included such as: name, date of birth, sex, height, color of eyes, and address.
- Military dependent's identification card.
- Native American tribal documents.
- United States Coast Guard Merchant Mariner Card.
- Driver's license issued by a Canadian government authority.
As part of its agreement with the FDA, the manufacturers will conduct point of purchase monitoring at individual pharmacies; clinics and doctor offices will not be subject to this point of purchase monitoring. If a pharmacist sells Plan B One-Step or Next Choice to someone under the age of 17, the manufactuers will "increase educational efforts regarding the age restriction and focus on improving the level of understanding among pharmacists and pharmacy staff." A second infraction will result in the pharmacist being reported to the State Board of Pharmacy.
Can purchasers of EC still get insurance/Medicaid reimbursement?
Individual insurance companies determine their own policies for coverage. Additionally, because Medicaid policies differ in each individual state, there won’t be one answer to this question. Right now, Medicaid covers no OTC product in approximately one third of states; some OTC products in one third of states, and several OTC products in the other third. However, many states with Medicaid coverage for OTC products require prescriptions for the OTC products. A group of advocacy organizations are working together to tackle this and other access issues for low-income women.
Where does EC need to be kept in a retail pharmacy?
Plan B One-Step and Next Choice must be kept where customers do not have direct access to the product (behind the counter), though it can be fully visible to customers.
Can pharmacist technicians sell Plan B One-Step and Next Choice?
The FDA requires that a health care professional must be available to answer questions if needed, but anyone behind the pharmacy counter will be able to sell EC OTC after seeing proof of age.
How do the FDA requirements for providing Plan B One-Step and Next Choice differ from the more stringent requirements for pseudoephedrine products?
The only requirements for pharmacies providing EC over the counter are that the purchaser is 17 or older and can show proof of age and that the product is kept behind the counter. Unlike the requirements for pseudoephedrine products, there is no requirement that pharmacies keep a log of purchaser names, addresses, or amounts purchased.
How much product can I sell and how much can a customer buy?
There is no limit to the number of doses that can be bought or sold over the counter. If EC is sold by prescription, a dose limit may be indicated by the prescriber.
Do I need any certification to sell Plan B One-Step or Next Choice?
No. No training or certification is required to sell EC over the counter. Some states that allow pharmacists to prescribe emergency contraception under collaborative agreement or another mechanism do require that pharmacists receive training. Pharmacists in these states who do not have training are still able to sell Plan B One-Step and Next Choice OTC to customers 17 and older.
Are there any government reporting requirements for sales of EC?
No. Unlike the requirements for pseudoephedrine products, there is no requirement that pharmacists keep a log of purchaser names, addresses, or amounts purchased.
Are Plan B One-Step and Next Choice OTC available in clinics?
Yes. Assuming they have a system in place for confirming age, health care clinics can distribute EC over the counter (OTC) to women and men 17 and older. In addition, they can continue to dispense EC to anyone who needs a prescription.
Additional resources:
Teva has developed Plan B One-Step educational materials for providers and pharmacists. They can be accessed here.