PPLE Module 2 Readings

Two offenses established by the FDCA

-Adulteration

-Misbranding

A RPh did not know a drug was adultered/misbranded and they sold it to a consumer. Did they violate the FDCA?

Yes, but they will not be subject to any penalties if they cooperate with the FDA and furnish the info about the source of the supply

How can the FDA enforce the FDCA?

-Issue a warning letter to the violate as a 1st step

-Bring an injunctive action against the violator to cease activity

-Institute criminal proceedings against violators, resulting in fines and/or imprisonment

-Seize any adulterated/misbranded F, D, or C

Park Doctrine

Establishes that corporate officials can be personally prosecuted without proof they acted intentionally or with negligence and even if they had no knowledge of the offense.

Adulteration provisions are intended to regulate a facility and the means of production, rather than the product itself. Why?

1. It is easier to inspect a facility than it is to inspect the individual products

2. Health and safety risk is much lower if the FDA can prevent adulteration rather than wait for it to occur and then recall.

T/F: Counting tablets on a dirty counting tray in a retail pharmacy counts as adulteration

True!

Clean your trays, you heathens.

Current Good Manufacturing Practice

cGMP

-Set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product.

Who must comply with cGMP?

-Manufacturers

-Pharmacies registered as an outsourcing facility

How often are facilities inspected by the FDA for compliance with cGMP?

Once every two years

What are the cGMP inspections designed to do?

-Confirm production and control procedures result in proper strength, quality, and purity of the drugs

-ID deficiencies

-Ensure correction of the deficiencies

What kind of defects does the FDA looks for in products?

-Subpotency

-Particulates

-Lack of content uniformity

-Dissolution failures

What happens if a facility is noncompliant with cGMP?

Could result in litigation against the company and declaration that the drugs are adulterated

Federal Anti-Tampering Act

It is a Federal offense to tamper or change consumer products

Tamper-evident package

"One having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred."

Misbranding vs Adulteration

Misbranding focuses on representations made by the manufacturer on the label or labeling

Adulteration deals with the drug's strength, purity, and quality.

T/F: The exact wording a drug's label or labeling must be approved by the FDA

True

T/F: The manufacturer labeling must contain a warning if a drug contains a habit-forming substance

False. It used to be required, but the FDAMA took that provision away and it is now only discretionary.

BUT

Manufacturers are still required to describe habit forming characteristics in the "Drug Abuse and Dependence" section of the package insert.

Adequate directions for use

Directions under which the layperson can use a drug safely and for the purposes of which it is intended

What happens if a manufacturer can't meet the "adequate directions for use" requirement?

Then the drug is classified as prescription and instead of needing adequate directions, they now need adequate information for use

A product is an imitation if it is....

-Identical in size, shape, and color

-Similar or virtually identical in gross appearance

-Similar in effect to controlled substances

What is included in an OTC Drug Facts panel?

-Active ingredients

-Purpose

-Uses

-Warnings

-Directions

-Other Info

-Inactive ingredients

-Questions? or Questions and Comments

When can the info contained in professional labeling be safely used?

Only under the supervision of the licensed prescriber

Can a pharmacist provide a patient with professional labeling?

Only if the patient requests it

Can a pharmacist recommend an OTC drug to a patient for a condition or dosage not listed on the product label?

Yes, but doing so may increase the pharmacist's risk of civil liability in the event of patient injury.

Info required for Rx product labels

-Name/address of manufacturer

-Name of product

-Active and inactive ingredients

-Statement of identity (generic/proprietary names)

-Weight and qty in container

-Statement of recommended or usual dosage

-"Rx only"

-ROA

-Lot/Exp date

-Type of container to dispense in

What happens if an Rx stock bottle is too tiny to fit the oodles of info required?

The info that doesn't fit can be put in other labeling on/within the package.

EXCEPT for the "Rx only" statement. That has to go on the bottle.

Info required on a unit dose package

-Drug name

-Qty of active ingredient

-Lot/exp date

-Manufacturer

-Statements required by compendia

-# of dosage units

-Controlled drug symbol if required by DEA

-"Warning: may be habit forming" where applicable

Why were package inserts changed in 2006?

Because they were overly complicated and poorly organized. Basically useless and no HCPs utilized them because they sucked.

What drugs are required to have the new package insert format?

-Drugs whose NDAs were submitted after 6/30/2001 (aka drugs from the date the new package insert was approved + 5 years prior)

Where can one access online drug labeling info, including the package insert and labeling history?

Drugs@FDA

Why is the FDA considering switching to electronic package inserts?

Because the labeling still sucks. The font is small, the paper is SUPER thin, and there are a bunch of folds that make it hard to open the info (god forbid you try to fold the damn thing back up).