Pharm Law lecture 4 Flashcards
What amendment was written as a result of the thalidomide disaster?
1962: Kefauver Harris Amendment
What did the Kefauver- Harris Amendment state? Which drugs did it affect
It required medications to be demonstrated not only safe, but also effective
This applied to all drugs marketed between 1938-1962 as well as new drugs
How did kefauver harris amendment affect marketing of drugs?
How did the kefauver harris amendment change clinical investigations?
Added requirements to clinical investigations including informed consent of research subjects and reporting of adverse drug rxns
What is cGMP? What does it ensure must happen to drugs manufactured in the USA?
cGMP= current good manufacturing practices. Any manufacture of drugs used in the US must be registered with the FDA and undergo an inspection at least once every two years.
What happens if a product does not comply with cGMP?
The product is adulterated.
What happens if a product is not registered with the FDA?
Adultered and misbranded
What are the three general categories making drugs falls into?
- Pharmacy or Traditional compounding (503a)
- Outsourcing Facilities (503b)
- Manufacturing
Define 503a, 503b and manufacturing
503a- compounding according to prescriptions specific to particular patients on an as needed basis
503b- Manufacturong large batches with or without prescriptions to be sold to facilities for office use only
manufacturing- mass production approved by FDA
What are some requirements for 503a (pharmacy or traditional compounding) that we should know?
- compound pursuant to a prescription only
- Compounding is for an individual patient
- Compounding only done by pharmacist, physician, or another individual under supervision
-Ingredients used in compounding are bulk substances which comply with USP-NF - Compounding cannot be a copy of commercially available product
- compounding can be done in advance, but only on a limited basis
Why is meeting the requirements for 503a important?
Meeting these requirements is important because compounding within these limits exempts the pharmacy from meeting regulations related to
-cGMP
-Misbranding
-New drug requirements
What are some requirements for outsourcing facilities (503b)
- compounding without receiving a prescription for a specific patient
- must register, pay annual fees and be inspected by FDA
- compounding cannot be a copy of commercially available product
For 503b, product labels must contain what things to avoid mislabeling
- the statement- “ this is a compounded drug”
- Name, Address, phone number of outsouricng facility
- Lot number or batch number
- Established name of drug
- dosage or strength
-QUantity or volume - Beyond use date
- Storage and handling instructions
-NDC - The statement- “Not for resale”
- List of active and inactive ingredients
Are there applicable laws misbranding, cGMP, New drug requirements (going through drug development process) for Pharmacy compounding (503a)?
No for all
For 503b, are there applicable laws for misbranding, cGMP and new drug requirements
Misbranding- Labeling/packaging requirements
cGMP- Yes
New drug requirement- No
For drug manufacturer, are there applicable laws for misbranding, cGMP and New drug requirements?
Yes to all
What to do for drugs that came out before 1962?
Before 1938, they can stay there.They are called grand father drugs. Its okay for you to still be in market.
After 1938 and before 1962- Desi drug. FDA reviews and investigates all of the medications. Products may remian on the market until a decision is made
What are the 5 steps of drug development process
Step 1- Preclinical research (invivo animal studies)
Step 2- Submission of investigational new drug (IND)
Step 3- clinical research (phase I, II, III)
Step 4- New drug application process (NDA)
Step 5- Post market safety monitoring (Phase IV)
define step 1 of drug development process
In vivo animal testing is utilized to record data and toxicity
What info must the IND contain (investigational new drug) in step 2?
The IND must contain the following info
- animal pharmacology and toxicology studies
- Manufaturing information
- clinical protocols and investigator info
once the IND is submitted, how long should the sponsor wait before initiating clinical trials
30 days
What happens during phase I of clinical trials
20-100 healthy human volunteers receive drug to evaluate safety and dosage of compound. Baseline human PK and pharmacologic properties are also reviewed and reported
Describe Phase 2 clinical trials
Phase 2 includes several hundred human volunteers who have the disease. It is to determine effectiveness of therapy
