PTCB Study Guide Chapter 2 - Stock Bottles, NDCs, Prescription Pregnancy Category
All pharmacy stock bottles must include the following:
1. Brand or generic name of medication
2. Strength of medication
3. The generic (chemical) name
4. Legend statement - all prescription bottles must have "RX Only" symbol or, "caution: federal law prohibits dispensing without prescription.
5. Storage requirements - whether bottle should be stored at room temperature or if it should be refridgerated.
6. Quantity of capsules, tablets, ect.
7. Dosage form - tablet, capsule, ointment, cream, ect.
8. Manufacturer name
9. Controlled substance mark - if the medication is a controlled substance, it's class must be in the upper right corner, for example, "CIII"
10. Lot number - Or known as control number. This number marks particular batches made by the manufacturer - if for some reason that a medication is recalled, it is pulled by that number.
11. Expiration date : if an expiration date only contains month and year of expiration, then it expires on the last day of that month. A "shelf life" is the period that properly stored medications will have effective use. After that period, the effective use is not assured.
12. NDC Number (National Drug Code) - The NDC number identifies each prescription bottle. The eleven numbers identify three pieces of information about the drug bottle.
- The first 5 numbers of the NDC identify the manufacturer.
- The second 4 numbers identify name, and strength of the drug.
- The third 2 numbers identify the package size.
Class I recall - a medication has been recalled because there is a strong chance of serious side effects or death to the patient.
Class II recall - there is a temporary chance of adverse effect to the patient.
Class III recall - A class III recall is when that particular medication is not likely to cause adverse effects.
The FDA requires all drugs to be classified in one of the five pregnancy categories. Each category reflects if that drug will have possible birth defects.
- Category A - Medication will cause no risk to fetus.
- Category B - Animal studies have been tested, although humans have not been tested.
- Category C- Either animal studies have had an effect on fetus, or both animals and humans have not been tested.
- Category D- Medication will cause risk to fetus.
- Category X - Medication will cause fetal abnormalities