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Prescription drug samples may only be distributed to licensed practitioners or to the retail pharmacies, the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
 
a. True
b. False


Prescription drug samples may only be distributed to licensed practitioners or to the retail pharmacies, the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
 
a. True
b. False

Answer: (b) False, [21 CFR 203.3 and Section 503(d) of the Act].
 
Under section 503(d) of the FFDCA, prescription drug samples may only be distributed to licensed practitioners or to the pharmacies of hospitals or other health care entities upon the written request of a licensed practitioner.
 
A “health care entity” means any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy (21 CFR 203.3(q)).
 
A health care entity cannot simultaneously also be a retail pharmacy.
 
If a pharmacy of a health care entity operates as part of the health care entity, it is eligible to receive prescription drug samples from a manufacturer or authorized distributor of record, if the drug samples are obtained pursuant to a written, signed request of a licensed practitioner affiliated with the health care entity.
 
“Affiliation” is interpreted to mean that the requesting practitioner sees patients at the health care entity. A retail pharmacy that has no relationship to a health care entity is not permitted to receive prescription drug samples (21 CFR 203.3 and Section 503(d) of the Act).