[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2740 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 2740

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
receipt of donated prescription drug samples by charitable health care 
                               entities.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 2, 2001

Mr. Burr of North Carolina (for himself and Mr. Kleczka) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
receipt of donated prescription drug samples by charitable health care 
                               entities.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Access Act of 2001''.

SEC. 2. DONATION OF PRESCRIPTION DRUG SAMPLES TO CHARITABLE HEALTH CARE 
              ENTITIES.

    Section 503(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(d)) is amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by striking ``paragraphs (2) and (3)'' and inserting 
        ``paragraphs (2) through (4)''; and
            (2) by adding at the end the following paragraph:
    ``(4)(A) A charitable health care entity may receive a drug sample 
donated by a person described in subparagraph (A), (B), or (C) of 
paragraph (1) or by another charitable health care entity for 
dispensing to a patient of the charitable institution, and a charitable 
health care entity may donate a drug sample to another charitable 
health care entity for dispensing to its patients, if the following 
requirements are met:
            ``(i) Delivery of the donated drug sample to the charitable 
        health care entity is completed by mail or common carrier, 
        collection by an authorized agent or employee of the recipient 
        charitable health care entity, or personal delivery by a 
        licensed practitioner or an agent or employee of the donating 
        charitable health care entity.
            ``(ii) The charitable health care entity receiving the 
        donated drug sample executes a written receipt for the drug 
        sample upon its delivery and provides for the return of the 
        receipt to the donating entity.
            ``(iii) The donated drug sample received by the charitable 
        health care entity is in its original, unopened packaging with 
        its labeling intact.
            ``(iv) Before dispensing such sample to a patient, the 
        sample is examined by a licensed practitioner or registered 
        pharmacist to confirm that the sample is not adulterated or 
        misbranded.
    ``(B) For purposes of this subsection, the term `charitable health 
care entity' means an entity that provides diagnostic, medical, 
surgical, or dental treatment or provides chronic or rehabilitative 
care; is described in section 501(c)(3) of the Internal Revenue Code of 
1986; and is under section 501(a) of such Code exempt from taxation.''.
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