Abbreviations
FDA
This Law prohibits falsely labeling pharmaceutical products and the sale of contaminated products
What is the Pure Food and Drug Act?
This is the schedule of Adderall
What is schedule II?
One of the reasons why we have special dispensing/prescribing requirements
What is keep patients using the medication safe?
Usually has less than 100 subjects
What is a phase 1 trial?
IND
What is an Investigation New Drug?
Oral Contraceptives and Estrogen-containing medications need one of these
What is a patient package insert?
Controlled Substance records need to be kept for this amount of time after inventory completion
What is 2 years?
Records of pseudoephedrine sales must be kept for at least this long
What is 2 years?
Group in charge of approving protocols and material used by researchers and protecting the heath and welfare of the volunteers
What is the Institutional Review Board (IRB)?
REMS
What is a Risk Evaluation Mitigation Strategy Program?
Examples of this include: lab results, labeled prescription vials, and patient identifiers
What is PHI?
This is the exception to the one time transfer rule for controlled substances.
What is pharmacies sharing an electronic real-time online database?
7.5g/30 days is the limit of pseudoephedrine that this type of pharmacy may sell.
What is Mail Order Pharmacy?
Preclinical tests need to test drugs in these before humans
What are Animals?
BLA
What is a Biologic License Application?
When State and Federal Laws are different, you should do this
What is follow the stricter law?
Valid or Not: AL3184532
Valid?
This lab is required as part of the Clozapine (Clozaril) REMS program
What is an absolute neutrophil count (ANC)?
This team contains pharmacist and pharmacy technicians who are dedicated to helping the study investigator with the study while maintaining regulations and ensuring compliance
What is Investigation Drug Services (IDS)?
DEA
This organization provides regulation for infection control
What is the CDC?
A schedule III and IV prescription can have this many refills within 6 months.
What is Five?
The amount of pseudoephedrine that community pharmacies are allowed to sell
What is 3.6g/day or 9g/30 days
Another name for phase 4
What is post-market testing?