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药学专业英语16课第二部分:FDA Policeman or Teacher
;;2. FDA: Policeman or Teacher?;Not only do persons undergo such identity crises but at times organizations and agencies also experience this type of traumatic soul-searching.;In a number of respects, the behavior of the Food and Drug Administration has appeared to this writer as suggesting that it is similarly uncertain as to its proper role or function. ;In particular, the Agency has often acted ambivalent and wavering as it has moved back and forth between at least two distinctly different roles: namely, that of a police officer and that of a teacher.
;By law, the FDA has responsibility to oversee the purity, quality, identity, safety, usefulness, and related characteristics of the nation’s food, drug, and cosmetic supply. ;With this legal mandate, the Agency is clearly a regulatory body and must operate in a manner to assure compliance.
;But compliance itself can be achieved by at least two different routes.
;There is, of course, that of close
supervision and monitoring combined with
various enforcement measures. ;However, to rely solely on this approach would virtually necessitate one FDA agent for each person being monitored—clearly an unrealistic system.
;This same problem is encountered in other aspects of day-to-day living; for example, adherence to traffic regulations and payment of income taxes. ;Both of these systems basically rely on
voluntary compliance by the general public,
coupled with spot checks of driving speed
and sampling of tax returns for auditing. ;Similarly, the FDA must primarily rely on
the voluntary compliance of those who
operate within the professions and industries
that are responsible for the products over
which the FDA has jurisdiction. ;This voluntary compliance is encouraged
by a parallel program of regulatory
enforcement via product sampling, batch
testing marketplace surveys, plant
inspections, and so on.
;Today. Thank you for listening!
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