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

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 113-120

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EIGHT

Other Classes of Drugs — Biologics,

Blood, “Cells, Tissues, and Organs,”

and Radiopharmaceuticals

A. INTRODUCTION

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.

B. SCHEDULE D

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.