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 at the pharmacy?
Progestin-only emergency contraceptive pills, like Plan B One-Step, Next Choice One Dose, Next Choice and Levonorgestrel Tablets 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. EC pills 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. ella (ulipristal acetate) is sold by prescription only.
Is emergency contraception covered under the Affordable Care Act (healthcare reform)?
The new health care law requires insurance companies to cover the full range of FDA-approved contraceptive methods and to cover them without imposing extra charges, like co-pays. This provision went into effect for new health plans very recently -- starting on August 1, 2012 (or when the new plan year begins) -- so insurance companies are just starting to make these changes, and it is still unclear how EC will be covered. Your plan may not cover every brand of EC, or over-the-counter products. The best way to find out if EC is covered by your plan is to call your insurance company. The National Women’s Law Center provides a very helpful guide to what questions to ask your insurance company to understand your contraceptive coverage. Ask which brands of EC might be covered, and find out if your plan requires a prescription for insurance coverage. If your plan does not cover over-the-counter EC, you may want to get a prescription so that you will have coverage, even though progestin-only EC (like Plan B One-Step or Next Choice) is available without prescription if you are 17 or older.
Can purchasers of EC OTC still Medicaid reimbursement?
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.
Can pharmacies provide EC to women under 17 years old?
OTC access for Plan B One-Step, Next Choice One-Dose, Next Choice and Levonorgestrel Tablets 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. Collaborative practice agreements may not apply to ella.
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 to purchase Plan B One-Step, Next Choice One Dose, Next Choice and Levonorgestrel Tablets directly from the pharmacist 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?
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 their 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, Next Choice One Dose, Next Choice or Levonorgestrel Tablets 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.
Where does EC need to be kept in a retail pharmacy?
Progestin-only EC (Plan B One-Step, Next Choice One Dose, Next Choice and Levonorgestrel Tablets) must be kept where customers do not have direct access to the products (behind the counter), though they may be fully visible to customers.
Can pharmacist technicians sell progestin-only EC?
The FDA requires that a health care professional must be available to answer questions if needed, but anyone behind the pharmacy counter can sell EC OTC after seeing proof of age.
How do the FDA requirements for providing progestin-only EC 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 of progestin-only EC (Plan B One-Step, Next Choice One Dose, Next Choice or Levonorgestrel Tablets) that can be bought or sold over the counter. If it is sold by prescription, a dose limit may be indicated by the prescriber.
Do I need any certification to sell progestin-only EC?
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, Next Choice One Dose, Next Choice and Levonorgestrel Tablets OTC to customers 17 and older.
Are Plan B One-Step, Next Choice One Dose, Next Choice and Levonorgestrel Tablets available OTC 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.
Is ella available OTC?
No - ella (ulipristal acetate) is sold by prescription only.
Teva has developed Plan B One-Step educational materials for providers and pharmacists. They can be accessed here.