Reg of Pharmacy Practice

The FDAs orange book is defined as?

Approved drug products with therapeutic equivalence evaluations

Therapeutic equivalent is defined as

Having the same effect and safety

What is the criteria for the OB rating system?

FDA approved (NDA OR ANDA)

Pharmaceutical equivalent

Bioequivalent

What does B mean in the coding system?

equivalence suspect or not proven

could mean: not therapeutically equivalent, issues, potential for issues, insufficient date FDA

Does substituting a B-rated product violate federal law?

NO- however could violate state law

In the coding system the second letter means what?

Dosage form or product nature

AA: no bioequiv issues

AB: bioequiv issues resolved

AN: inhalation

AO: oils

AP: aqueous

AT: topical

Absent identifying code is deemed as

Adulterated and misbranded

Creation of generic biologics leads to

Competition

Decrease in price and Increase in efficacy and innovation

Why was the law change for biologics needed?

it previously only applied to products which are all small chemical compounds, and most of thes biomolecules are large in nature

BPCIA is similar to waxman hatch in that?

Congress is seeking a generic approval process to promote competition

Biosimilar definitions

Highly similar to the reference product

No clinically meaningful differences

NOT pharmaceutical equivalents

What is a key issue with biosimilars?

Interchangability

BPCIA is unlike waxman-hatch in that it requires some

Clinicals

For the BPCIA the sponsor must submit?

Structural and functional analysis

Animal and Human data

Title IV of the FDA Safety and Innovation act did what

provided for user fees to facilitate new product approval

Is the regulation of prescribing and dispensing state or federal?

States, they determine the conditions for prescribing and dispensing

FDA asserts it is misbranding for the pharmacist to dispense with out

PPI

Medguides

PPIs are dispensed

every time patient receives medication

Med guide drugs are

often part of REMS
and are required with every fill and refill

FDAAA accomplished what

Permit restrictions on distribution

Labeling changes - call doctor for medical advice about side effect

Expanded authority of FDA in the post marketing phase (REMS)

FDA may require REMS in the context of need to improve safety, an example of this may be

Patient communication plan

Professional communication plan

ETASU

What is the goal of REMS

Allow medication to stay on market by managing emergent risks

FDA requirements for addictive drugs

Training

Patient counseling

MedGuides

PPPA which was made by the CPSC left an exception for

OTCs, can label not for children

PPPA packaging examples include

Glass or threaded plastic one time use containers

For the PPPA how can a pharmacist dispense a drug without PPP

By having the patient sign a waiver once and keep on file

Failure to comply with CRP results in

Misbranding

CRP is different than tamper evident how?

Not designed to prevent access by children but to demonstrate potential tampering

Tamper evident/CRP can be both

adulterated and misbranded

Tummino v Hamburg ordered

All levonorgestrel-containing products made available without prescription based on citizen petition

What are the findings in the tummino case?

Levo is the safest OTC

Only acts pre fertilization

FDAs decision making process was inconsistent with past