1. Mr. Roger Garfield Watts, BSOE, CPhT

2. Participants will successfully complete
pharmaceutical training, and all related
activities, to fulfill patient care
requirements commensurate with the
duties of an upgraded military
pharmacy technician.

4.  Understand and comply with major federal laws and
pharmaceutical standards of practice regarding
outpatient dispensing of pharmaceuticals.
 Identifylegal standards in documentation involved in
medication dispensing e.g., patient prescriptions,
Drug Enforcement Agency (DEA) numbers.

5.  Constitutional Law
 Outlines the organization of the federal government
 All states must comply with constitutional law
 Overrides other laws—such as state law
◦ When there is a conflict between state and federal laws,
the general standard of practice is to follow the most
stringent law or practice

6. Food, Drug, and Cosmetic Act (FDCA) of 1938
 The FDCA of 1938 stems from (amended) the 1906 Federal Pure
Food and Drug Act
 Both Acts mainly dealt with prohibiting adulteration and misbranding
of drugs…The laws also encompasses many aspects of consumer
protection
 Adulteration occurs if a product contains any filthy, putrid, or
decomposed substance. A drug is adulterated when it is packed or
held under unsanitary conditions or when its strength, purity, or
quality does not comply with its label
 Misbranding results if the label is false or misleading, or if it does
not contain directions for use, precautions, and in some cases, the
statement, “Warning—May Be Habit Forming.” It also applies to
pharmacists who supply or refill prescription drugs without
prescriber authorization

7. Kefauver-Harris Amendment (KHA)
 The FDCA required that a product’s safety must be proven; it did
not, however, require proof of efficacy, or effectiveness before
approval from The Food and Drug Administration, (FDA). Therefore,
drugs were not subject to rigorous testing before approval.
 The Kefauver-Harris Amendment (KHA) of 1962 is best noted for
requiring proof of efficacy of drugs before the FDA approved them.
The KHA applies to all drugs introduced after 1962 and drugs that
had new applications approved from 1938 to 1962.

8. This is the last slide for this part of the lesson. Please
close this lesson and watch the two short You Tube clips,
lesson video 1 on the Pure Food and Drug Act, and lesson
video 2 on the Kefauver-Harris Amendment.
Upon completion of the You Tube video 2 clip,
Kefauver-Harris Amendment, use your knowledge
of KHA to blog your thoughts on the Rx Law
Review Chat, then continue with Pharmacy Law
Lesson part 2.