Other Classes of Drugs - Biologics, Blood, 'Cells, Tissues, and Organs,' and Radiopharmaceuticals

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Other Classes of Drugs Biologics,
Blood, “Cells, Tissues, and Organs,”
and Radiopharmaceuticals
ere are several schedules to the Food and Drugs Act (FDA) that delineate
the scope of certain rules in the Act; for example Schedule C (radiopharma-
ceuticals and drugs other than radionuclides sold or represented for use in
the preparation of radiopharmaceuticals) and Schedule D (biologics).
is chapter provides a brief overview of the additional regulatory
requirements for drugs that are listed on one of these Schedules, as well as
rules that apply to minimally manipulated cells and tissues.
Schedule D includes allergenic substances used for the treatment or diagno-
sis of allergic or immunological diseases; anterior pituitary extracts; drugs
obtained by recombinant DNA procedures; drugs, other than antibiotics,
prepared from micro-organisms; and drugs that are or are made from blood,
immunizing agents, insulin, and monoclonal antibodies. Blood, semen, and
other minimally manipulated cells and tissues for transplantation are also
classied as biologic drugs and have their own regulations that govern how
they are retrieved and processed, and when they can be distributed.
RSC , c F-.
Section . of the Assisted Human Reproduction Act, SC , c , as amended,
removed sperm and ova from the FDA.

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