Professional Documents
Culture Documents
1. A misbranding refers to label that is false, and misleading, and in other words does not reflect the
true contents of the container to which labels are affixed. Examples are prescription written for
Adalat but filled for Procardia, an original bottle labeled 50 tabs contains only 60 tablets and names
of active/inactive ingredients are missing.
2. If a prescription bottle has an expiry date of July 08, it means the pharmacist can dispense until
July 31.
3. Drug references are required for retail or outpatient pharmacy and must be current. Following
references are required USP, NF, pharmacology, drug interactions, and Michigan OR ANY STATE
LAW pharmacy laws and public health codes.
4. Adulteration refers to the composition of a product. A drug is adulterated if it contains in whole or
in part of any filthy, putrid or decomposed substance, if is prepared or packed under unsanitary
conditions, if does not fall under GMPs or becomes contaminated. Examples are an herbal product
which contains American ginseng rather than the Chinese ginseng listed on the label, a product on
the shelf for the sale is past its expiration date, sterile parenteral solution contains a few
microorganisms, assay or purity is lower than that listed on the lable and active/inactive
ingredients have gone partial decomposition.
5. All dispensed prescription medication containers are required to bear a label containing at a
minimum of pharmacy name and address, Rx number, patients name, the date Rx was most
recent dispensed, prescribers name, direction for use, any cautionary statement and the name of
medication. The Rx must also bear discard this medication one year after the date it is dispensed.
All labeling of Rx drugs shall comply with the requirement of the code of federal FD and C Act.
6. All dispensed prescription medication containers are required to bear a label containing at a
minimum of pharmacy name and address, Rx number, patients name, the date Rx was most
recent dispensed, prescribers name, direction for use, any cautionary statement and the name of
medication. The Rx must also bear discard this medication one year after the date it is dispensed.
All labeling of Rx drugs shall comply with the requirement of the code of federal FD and C Act.
7. In addition to the manufacturers original label on OTC drugs, which cannot be defaced or altered
or covered, the pharmacist or pharmacy intern shall affix name of dispenser, the name and address
of pharmacy on OTC products.
8. FDA labeling requirement for OTC drugs are active ingredient, purpose, uses, directions, inactive
ingredients, lot number and expiry date.
9. For DAW, the prescriber has to write on Rx paper and electronically transmitted Rx must state
another brand of a generically equivalent product identical in dosage may be dispensed.
10. A pharmacist must write GEQ for the drug dispensed on the Rx label if it is not a brand name or
brand is not available and must tell purchaser. If drug product selection takes place, the brand
name or the name of the manufacturer or the supplier shall be noted on Rx label. This rule does
not apply to inpatient medical institution.
11. When a pharmacist receives a prescription for a brand name drug, the pharmacist may or when a
purchaser requests a lower cost GEQ drug, the pharmacist shall dispense a lower cost drug but not
higher cost GEQ drug if available in the pharmacy. Its a federal law.
12. A pharmacist, who substitutes a drug knowing or intending that it will be used, is subject to
licensure discipline including fines, suspension, revocation, probation, restitution and community
services.
13. A pharmacist shall not knowingly dispense a prescription after the death of prescriber or patient.
14. Vouchers intended for filling from the pharmacys stock and starter dose packs from
pharmaceutical companies are legal for community pharmacies to possess for the dispensing of
prescription drugs.