Author Question: In the early 1800s, it became clear that the standardization of drug purity and strength was ... (Read 14 times)

laurencescou · **on:** Jul 23, 2018

In the early 1800s, it became clear that the standardization of drug purity and strength was necessary. Which reasons reflected this need?

1. Strength and purity of products varied from region to region and batch to batch.
2. Strength and purity of products depended on the pharmacist's experience.
3. Strength and purity of products would vary in size, taste, and nutritional value.
4. Strength and purity were mostly guaranteed if products were produced locally, which caused a hardship for those outside the region.
5. Strength and purity could be trusted when the product had gone through extensive local testing.

Question 2

The Pure Food and Drug Act (PFDA) of 1906 was significant in that it gave the government the power to prohibit drug labels from claiming false therapeutic benefits.

However, there were still several weaknesses in the legislature of this act. Which statements most accurately describe these weaknesses?
1. This law did not require drug manufacturers to prove that the drug was effective in its claims.
2. This law did not prevent drugs from being marketed for any disease.
3. This law required all drug labels to accurately describe their contents.
4. This law required adequate testing for safety prior to marketing.
5. This law did not encourage the development of drugs for rare or unusual disorders.

dudman123 · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

Correct Answer: 1,2,3
Rationale 1: The strength and purity of the products varied considerably because they were dependent on the experience of the pharmacist and the quality of the local ingredients, which could vary from region to region and batch to batch.
Rationale 2: The strength and purity of the products varied considerably because they were dependent on the experience of the pharmacist and the quality of the local ingredients, which could vary from region to region and batch to batch.
Rationale 3: The strength and purity of the products varied considerably because they were dependent on the experience of the pharmacist and the quality of the local ingredients, which could vary from region to region and batch to batch.
Rationale 4: Strength and purity could not be guaranteed, even if produced locally. Causing a hardship on those outside the region had nothing to do with determining that standardization was needed.
Rationale 5: Extensive testing prior to marketing did not occur until the early 1930s.
Global Rationale: The strength and purity of the products varied considerably because they were dependent on the experience of the pharmacist and the quality of the local ingredients, which could vary from region to region and batch to batch. Because of this, standardization was necessary. Strength and purity could not be guaranteed, even if produced locally. Causing a hardship on those outside the region had nothing to do with determining that standardization was needed. Extensive testing prior to marketing did not occur until the early 1930s.

Answer to Question 2

Correct Answer: 1,2
Rationale 1: The fact that manufacturers did not have to prove efficacy was a tremendous weakness in the regulation of drugs in the early 20th century.
Rationale 2: The PFDA of 1906 did not address false therapeutic claims.
Rationale 3: Requiring drug labels to identify their contents is not a weakness of the PFDA.
Rationale 4: The PFDA did not require testing for safety prior to marketing. It was not until Congress passed the Food, Drug, and Cosmetic Act that drugs had to be tested for safety prior to marketing.
Rationale 5: The act that encouraged the research and development of drugs for rare or unusual disorders is called the Orphan Act.
Global Rationale: The weaknesses of the PFDA of 1906 include the fact that manufacturers did not have to prove efficacy in the regulation of drugs in the early 20th century and the Act did not address false therapeutic claims. Requiring drug labels to identify their contents is not a weakness of the PFDA. The PFDA did not require testing for safety prior to marketing. It was not until Congress passed the Food, Drug, and Cosmetic Act that drugs had to be tested for safety prior to marketing. The act that encouraged the research and development of drugs for rare or unusual disorders is called the Orphan Act.