18 
criteria for buildings, equipment, 
components, laboratory controls, product 
containers, packaging, records and 
reports, etc. 3_2/ If "the methods used 
in, or the facilities or controls used 
for, [a drug's] manufacture, processing, 
packaging or holding do not conform to 
or are not operated or administered in 
conformity with current good manufactu- 
ring practices ..." the drug will be 
found to be adulterated. If it is, it 
may not be introduced into interstate 
commerce. Although the sanction is 
against the product, the regulation 
necessarily entails monitoring the 
process . 
(4) For some drugs and all biologies, FDA 
has the authority to require testing of 
all the product. For insulin and 
antibiotics, FDA requires that each 
batch be tested to show safety and 
purity. 33_/ With biological products, 
tests are required for each lot prior to 
release. 347 "[I]t is the administra- 
tive practice of the Office of Biologies 
to require lot by lot approval of many 
biologies before they are released by 
the manufacturer." 35 / 
(5) All genetically engineered pharma- 
ceuticals are considered "new drugs", 
even if identical to a previously 
32/ 
21 C.F.R. 
§§ 210-26 (1982). 
33/ 
21 U.S.C. 
§§ 356, 357 
34/ 
21 C.F.R. 
§ 610.1 
35/ 
See Office 
the United 
of Technology Assessment of the Congress of 
States, Commercial Biotechnology: An 
International Analysis 361 (U.S.G.P.O. 
January 1984). 
[718] 
