Module 3 - Federal Regulation of Drugs

Legal definition of a Drug per FDCA

• recognized by USP/NF or homeopathic pharmacopoeia

• use in diagnosis, cure, mitigation, treatment, or prevention of disease

• non-food article that affects structure or function of the body

Labeling requirements for OTC drugs?

• must be labeled with instructions for LAY people that indicates their safe and effective use

• DRUG FACTS!!!

Drug packaging requirements for OTC drugs?

• must be in tamper-evident pkg

  • unless insulin, lozenges, toothpaste, or dermatological

• OTC label must indicate the presence of tamper-evident features

  • considered misbranded if this is missing!

are syringes RX or OTC in WI?

OTC

labeling requirements for Rx only drugs?

• must contain a LEGEND that states

  • RX only or

  • CAUTION: federal law prohibits dispensing without a prescription

Rx drugs - what is required to be on the commercial container

• generic and proprietary name

• quantity/concentration

• quantity of finished dosage forms

• ingredients: active and inactive

• route of admin, if not oral

• dosage or reference to package insert

• federal legend (Rx only)

• lot and exp date

• name and address of mfr, packager or distributor

Dietary supplement labeling requirements

• SUPPLEMENT FACTS

• this statement has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease!)

Can dietary supplement make structure and function claim?

YES - just not treat, cure, or prevent disease

Drug Supply Chain and Security Act

What MUST pharmacies do when they receive a drug?

1. Verify and confirm trading partners’ credentials

2. Obtain and store drug tracing information

3. Investigate any suspected illegitimate drug products

What 3 pieces of product tracing documentation do we need to know BEFORE we accept drugs?

1. transaction information - details of drug in the sale (name, qty, lot #, dates, etc)

2. transaction hx - hx of all above info for each sale going back to mfr

3. transaction statement - statement declaring compliance with DCSCA (sellers statement)

How long to store drug tracing infromation?

6 YEARS

what is drug serialization

all rx drugs must have a DSCSA compliant identifier

what to do when suspecting counterfeit, diverted, stolen, or unfit medications?

• work with manufacture

• notify FDA and trading partners