Study Set Content:
risk > benefit (daw X mo nga wala pulos)
Category X
FDA Pregnancy Categories
• Category A
• Category B
• Category C
• Category D
• Category X
• FDA’s strongest labeling requirements for high-risk medicines
Black Box Warnings
• Most serious warning placed in the labelling of a prescription medication
Black Box Warnings
first Black Box Warning
Chloramphenicol
not allowed in Black Box Warnings
Advertisements or “reminder ads”
– Reasonable probability of serious adverse health consequences or death
• Class I
May cause temporary or medically reversible consequences
• Class II
Not likely to cause adverse health consequences
• Class III
Drug Product Recall
• Class I
• Class II
• Class III
current good compounding practices
Compounding
current good manufacturing practices
Manufacturing
: that which holds the article and is or may be in direct contact with the article
USP
that which is in direct contact with the article at all times
• Immediate container
• Must be clean and dry before it is filled, and must not physically or chemically interact with the drug
Containers
Minimally acceptable container; Protects the contents from extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution
Well-closed
: Protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution, and is capable of tight reclosure
Tight
: Impervious to air or any other gas under ordinary conditions
Hermetic
For parenteral preparations
Sterile Hermetic
Holds a quantity intended for a single dose and cannot be resealed once opened
• Single-dose
