Law Week 5
Additional adulteration examples
-Prepared, packed or held in conditions where it may have been contaminated -Exposed to a container that may have contaminated it -Manufactured under conditions that do not conform to CGMP -Contains an unapproved color additive -Contains any ingredient as a substitute for the active drug
If package too small, the following can be in labeling/package:
-Recommended dosage -Route of administration -Inactive ingredients -Type of container
How can pharmacies violate adulteration provisions?
-Repackaging of products that may contaminate the product -Storage of drug inventory outside of temperature ranges -Overfilled stock bottles
What constitutes misbranding? Labeling...
-missing either the name or location of the manufacturer, packer, or distributor -does not contain a word, statement or other information required by law to be displayed in a prominent, readable manner -does not state 'Rx only' if the drug is available only by prescription -does not contain a precautionary statement for a drug product that is subject to deterioration -has inadequate directions for use of OTC or does not include appropriate warnings
Labeling must include:
-not be false or misleading -a listing of active ingredients and quantity -a listing of inactive ingredients in alphabetical order -adequate directions for use -adequate warnings against use by children and others for whom use might be dangerous
New pregnancy warnings
-provide information relevant to the use of the drug in pregnant women, including dosing and potential risks to the fetus -lactation information -Females and Males of Reproductive Potential
What must labeling include for OTCs?
-statements of all conditions, purposes, or uses for the drug (Intended and Commonly used) -Directions under which the layperson can use a drug safely and for the purposed intended -Includes adequate warnings for use -Labeling must be complete enough to inform the consumer that the drug should be used for the consumer's particular ailment -Quantity or dosage for each intended use (differing ages and physical conditions) -frequency/duration/time of administration or application -Route or method of administration or application -The preparation necessary
Prescription drug package inserts include all of the following types of information EXCEPT:
Average Wholesale Pricing (AWP)
Package Inserts
Contains essential scientific and medical information needed for safe and effective use of the drug by healthcare professionals; cannot be promotional or misleading; FDA specifies content and format
A drug product consisting of tablets may be declared adulterated for all of the following reasons EXCEPT:
Does not indicate the number of tablets present
Labeling for rx drugs must include:
Drug's indication, Side effects, Dosages, Routes, methods, frequency and duration of administration, Contraindications, Other warnings and precautions for administration, prescribing or dispensing safely
What does the CGMP do?
Ensure drug is safe and meets quality and purity requirements; manufacturers must be registered with the FDA and are inspected every 2 years
Black box warning
FDA can require when use of a drug may lead to death or serious injury; should include in counseling, if applicable; doctors are often unaware, we should educate them
Federal Anti-Tampering Act
Made it a federal offense to tamper with consumer products; created because of tylenol laced with cyanide in 1982; this is the reason we have tamper-resistant bottles now
A pharmacist dispenses a refill for a prescription that originally was written for Adalat but labels the refill as Procardia. This action may be considered?
Misbranding (Mislabeling)
What is the 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
Into how many segments is the national drug code (NDC) number on a pharmaceutical package divided?
Three
Old pregnancy warning system
category A, B, C, D, X
What is the second segment of the NDC?
identifies a specific strength, dosage form and formulation of the drug
What is the third segment of the NDC?
identifies package size and type
What is the first segment of the NDC?
identifies the manufacturer or distributor
What is an adulterated drug?
if its strength, quality or purity differs from compendia standards or the label
What is it if a drug imitates another drug? (i.e. pharmacist dispenses generic as name brand)
misbranding
Adequate directions for use
over-the-counter drug
adequate instructions for use
prescription drug
Current Good Manufacturing Practices (CGMP)
product is adulterated unless the manufacturer complies with this
What two things do adulteration provisions focus on?
the facility and the product