Wk7 Kefauver Harris & Durham Humphrey Amendment Pharmacy Law Reflection Reflect on the content assigned using the below questions as a guide, at a minimum:
Wk7 Kefauver Harris & Durham Humphrey Amendment Pharmacy Law Reflection Reflect on the content assigned using the below questions as a guide, at a minimum:
Research the Durham-Humphrey’s Amendment (1951). What were its most significant impacts on pharmacy practice?
Select a law or regulation, past or pending, and do historical research on it. Reflect on the Law’s impacts (or projected impact) and your experience in researching it? What was your approach to finding the information you needed.
Locate additional resources for the content of Week #5 (besides the Durham-Humphrey’s Amendment, Affordable Care Act, and your selection above). Describe what you found and its usefulness to this course.
How effective were the assigned readings in presenting this information?
What other relevant questions would you ask about this content?
Please use 12-point, Times New Roman font with 1.5 or 2.0 spacing.
Minimum 2 pages of reflection.
At least 3 cited sources. History of Pharmacy SIG
Teaching History of Pharmacy
According to the AIHP
Guidelines:
C. Pharmacy Regulation via
State and Federal Governance
Created by David M. Baker,
BS Pharm, MBA, JD
Western New England
University College of Pharmacy
& Health Sciences
Developed by the Teaching History of Pharmacy Committee
of the History of Pharmacy SIG, 2017-18
Picture: Pharmacist at People’s Drug Store No. 5, Washington, DC, c. 1920. Library of Congress Prints and Photographs, LC-USZ62-129891
State Pharmacy Law Development
•Initially, in early 1800s, the few
attempts at “regulation” of
profession were typically limited to
local level laws
•As slowly moved toward state level
regulation, early attempts often
were developed in combination with
medical practice laws.
State Pharmacy Law Development
•1808 – Territory of Orleans (became
Louisiana in 1812): pharmacists had
to prove qualifications; examined by
Board of Physicians; banned sale of
deteriorated drugs; restricted sale of
poisons
•1840 – 1st state board of pharmacy
•1852 – pharmacy act was repealed
One of the First State-Licensed
Pharmacists
State Pharmacy Law Development
•Other State Pharmacy Acts:
•1817 – South Carolina
•1838 – penalty component was
repealed
•1825 – Georgia
•1852 – Alabama
State Pharmacy Law
Development – Common Law
• Thomas v. Winchester, 6 N.Y. 397 (N.Y. 1852) –
established duty to dispense (label) correctly
• Fleet and Semple v. Hollenkemp, 52 Ky. (1 B
Mon.) 219 (1852) – changed pharmacy
purchases from caveat emptor to caveat vendor
• Burgess v. Sims Drug Co., 86 NW 307 (Iowa
1901) – pharmacists & employers equally liable
• Peters v. Johnson, 41 SE 190 (W.Va. 1902) – high
degree of care & prevent foreseeable harm
State Pharmacy Law Development
•State regulation of pharmacy
practice prior to 1870 did not
typically involve pharmacists
directly:
•against drug adulteration
•restricted poison sales
•prohibited advertising or selling of
abortifacients
State Pharmacy Law Development
•1869 – APhA Meeting: after much
rancorous debate concerning rural
areas without pharmacies and a fear
of bureaucracy, a model state
pharmacy act was drafted. This
would quickly be adopted by states
as their state law.
State Pharmacy Law Development
•Adoption of Model Pharmacy Act,
creating Pharmacy Boards and
standards for pharmacists and
pharmacy practice:
•1870 – Rhode Island first
•By 1878 – 8 more states and D.C.
•In the 1880s – 21 more states
•In the 1890s – 12 more states
State Pharmacy Law Development
•In 1900, the Model Pharmacy
Practice Act was revised by APhA
without any controversy.
•Currently, the Model Pharmacy
Practice Act is updated and
maintained by the National
Association of Boards of
Pharmacy.
Federal Pharmacy Law Development
• Precipitating Events:
• Fraudulent production, advertising and distribution of fake smallpox
vaccine, at extravagant prices.
• Vaccine Act of 1813
• Purpose was to encourage and increase smallpox vaccinations.
• Created a single federally-appointed agent, whose responsibilities were
to:
• preserve the genuine smallpox vaccine matter; and
• to furnish the same to any citizen of the United States, whenever it may
be applied for, through the medium of the post-office (carried free of
charge by the post office).
• Repealed May 4, 1822 – result of an 1821 outbreak of smallpox in North
Carolina, which was traced to contaminated vaccines provided by Dr.
John Smith while in the capacity of the federal agent charged with
preserving and distributing genuine vaccine.
Federal Pharmacy Law Development
• Precipitating Events:
• Complaints by pharmacies that drug products (crude
product) were adulterated or not of specified
concentrations.
• Claim was that this was primarily IMPORTED product.
• Drug Importation Act of 1848:
• Examined all imported products for quality, purity and
fitness for purpose.
• Established Pharmacopoeia of the U.S. and U.S.
Dispensatory as official standards.
• Administered by the Department of the Treasury.
Federal Pharmacy Law Development
•Precipitating Events:
•Tetanus contamination in diphtheria vaccine.
•Most vaccines produced on farms using
production animals (horses, cattle).
•Biologics Control Act of 1902:
•Treasury Department licensed and inspected
biologics manufacturers, and regulated
production and labeling of biologics.
•National Sanitary Board (the SurgeonGenerals of the Army, Navy and MarineHospital Service) promulgated regulations.
Federal Pharmacy Law Development
Muckraking Journalism – Early 20th
Century
Federal Pharmacy Law Development
• Precipitating Events:
• Muckraking journalism: Upton Sinclair’s The Jungle (meat
packers) and Samuel Hopkins Adams’ Great American
Fraud (patent medicines)
• Harvey Wiley’s advocacy (worked in Agriculture Dept.’s
Bureau of Chemistry)
• Pure Food and Drug Act of 1906:
• Defined “drug,” and regulated the adulteration or
misbranding of drugs.
• Regulations promulgated jointly by the Treasury,
Agriculture, and Commerce & Labor Departments;
Bureau of Chemistry (in Ag. Dept.) performed any
necessary tests.
• Established U.S. Pharmacopoeia and National Formulary
as drug standards.
Federal Pharmacy Law Development
• Precipitating Events:
• Realization of the extent of addiction to opiates and
other narcotics among the general public through
prescription and patent remedies.
• International Treaty concerning addictive substances
at the Hague in 1912, to which the U.S. was a
signatory.
• Harrison Anti-Narcotic Act of 1914:
• Established control over the manufacture, distribution
and dispensing of certain addictive substances (e.g.,
opium, morphine and cocaine) in high concentrations,
primarily through taxation and required labeling.
Federal Pharmacy Law Development
Federal Pharmacy Law Development
• Precipitating Events:
• Many had advocated for new law for years due to
ineffectiveness of 1906 law – could only prosecute
fraudulent, not misleading labelling, due to 1911 US
Supreme Court decision
• Sulfanilamide Elixir (Massengill) tragedy of 1937 –
used diethylene glycol as solvent; 107 deaths plus
suicide death of creator
• Food, Drug and Cosmetic Act of 1938:
• Definition of “drug” expanded
• to include affecting body structures even in the
absence of disease (prevention); and
• by addition of the Homeopathic Pharmacopoeia of
the U.S. as a drug standard.
Federal Pharmacy Law Development
Food, Drug and Cosmetic Act of 1938
(continued):
•Drug labeling requirements became more
strict
•A drug could not be sold unless an
application for approval was on file with
the FDA.
•The newly created Food and Drug
Administration (FDA) was given general
administrative powers.
Federal Pharmacy Law Development
•Precipitating Events:
•No standard as to what required a prescription.
Previously, decision was left to individual
manufacturer to make.
•Durham-Humphrey Amendment or Prescription
Drug Amendment of 1951:
•Established two classes of drugs – prescription
and over-the-counter
•Established label and labeling requirements
unique to prescription drugs (exempted from
“adequate directions for use” requirement)
Federal Pharmacy Law Development
•Precipitating Events:
•- Use of thalidomide in pregnant women for
morning sickness from 1957 to 1962 (Europe) –
teratogenic effects: death and phocomelia
(estimated 10–20,000 cases worldwide)
•Drug Efficacy Amendment of 1962 (or KefauverHarris Amendment):
• Established Good Manufacturing Practices
(“GMPs”)
•Transferred regulation of prescription drug
advertising from the Federal Trade Commission
(“FTC”) to the FDA
Federal Pharmacy Law Development
Drug Efficacy Amendment of 1962
(continued):
•Required informed consent of all
human research subjects.
•Required reporting of adverse drug
reactions by manufacturers to FDA.
•New drug approval now required
proof of efficacy in addition to safety.
Federal Pharmacy Law Development
Federal Comprehensive Drug Abuse
Prevention and Control Act or Controlled
Substances Act of 1970
•Established the Drug Enforcement
Administration (DEA) from four different
federal agencies, including BNDD (Bureau of
Narcotics & Dangerous Drugs).
•Created five controlled substance schedules,
and prescription limitations for each class.
•Established criminal liability for illegal
possession or trafficking in controlled
substances.
Federal Pharmacy Law Development
Poison Prevention Packaging Act of 1970
• Requires child-resistant (= 80% of children
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