Answers to Frequently Asked Questions About...
How to Get Emergency Contraception
Q&A About Over the Counter (OTC) Access to Plan B
Where can Plan B be sold over the counter (OTC)?
Plan B can be sold only at the pharmacy counter. Because Plan B has a "dual label" - it is OTC for consumers 18 and older but only available by prescription to those under 18 - it will be available only in retail outlets that have a pharmacy with licensed professionals. It will not be 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.
If a pharmacist only has the old prescription packaging of Plan B in stock, can it be sold OTC?
No. Pharmacists may begin dispensing the newly packaged Plan B for OTC sales as soon as they receive the shipment (generally, mid-November 2006). The newly packaged Plan B may be sold as both a prescription and non-prescription product. If pharmacists have any remaining stock of the old Plan B (Rx only), they may only sell it as a prescription product.
Can pharmacies provide Plan B to girls under 18 years old?
Over the counter (OTC) access is limited to people 18 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 Plan B.
Can pharmacies sell Plan B 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 18 or older and can show proof of age. The FDA updated its website on 12/14/2006 to explicitly state that men can purchase Plan B.
What are acceptable forms of proof of age for Plan B purchase?
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's 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, Barr 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 to someone under the age of 18, Barr will "increase its 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 Plan B purchasers still get insurance/Medicaid reimbursement?
Individual insurance companies will 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 over the counter (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 Plan B need to be kept in a retail pharmacy?
Plan B must be kept where customers do not have direct access to the product (behind the counter), though it can be fully visible to customers.
Will pharmacist technicians be able to sell Plan B?
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 Plan B over the counter (OTC) after seeing proof of age.
How do the FDA requirements for providing Plan B differ from the more stringent requirements for pseudoephedrine products?
The only requirements for pharmacies providing Plan B over the counter are that the purchaser is 18 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 Plan B is sold by prescription, a dose limit may be indicated by the prescriber.
Do I need any certification to sell Plan B?
No. No training or certification is required to sell Plan B over the counter (OTC). 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 OTC to ?customers 18 and older.
Are there any government reporting requirements for Plan B sales?
No. Unlike the requirements for pseudoephedrine products, there is no requirement that pharmacists keep a log of purchaser names, addresses, or amounts purchased.
Will Plan B OTC be available in clinics?
Yes. Assuming they have a system in place for confirming age, health care clinics will be able to distribute Plan B over the counter (OTC) to women and men 18 and older. In addition, they will be able to continue to dispense Plan B to anyone who needs a prescription.
What will be the cost of Plan B to public sector clinics? To student health centers?
In a personal communication from Amy Niemann to James Trussell, 12/18/2006, Barr stated, "In pricing Plan B, our lowest price in the public sector is for 340B qualifying entities, which comprise the vast majority of public sector units sold. This group is comprised of the clinics where the patients who are most in need financially are able to get their Plan B at little or no cost. Presently, our 340B price is $8.58/unit. This is the calculated 340B price, based on government pricing restrictions. Although Plan B is available OTC for consumers 18 and over, Barr has decided to offer reduced pricing of $17.95/unit to Student Health Centers and other non- 340B entities. This is substantially lower than our price to retail entities."
Additional resources:
Barr Laboratories has developed Plan B educational materials for providers and pharmacists. They can be accessed at: http://go2planb.com/ForPrescribers/ResourceLibrary/SupportMaterials.aspx