Distribution & Dispensing of non-Rx products Flashcards
Federal Laws & OTCs
Federal Anti-Tampering Act 1982
Definition (OTCs)
- Tamper-resistant packaging for select OTC products and cosmetics
- Provides barrier to entry to protect against intentional contamination of OTCs
- Alerts consumer to tampering (i.e. safety seals)
OTC Labeling Requirements
What are the components of a 7-point label? If any component is missing, then the product is considered as what?
- Name of product
- Name/address of manufacturer, packer, distributor
- Net contents of package
- Established name of all active ingredients and certain inactive ingredients
- Name of any habit-forming drug present
- Cautions/warnings to protect consumer
- Adequate directions for use
If missing, then the product is MISBRANDED
OTC Labeling Requirements
What are other specific labeling requirements that, if missing, may lead the product to be misbranded?
“other labeling may include…”
- Statement of intended use
- Dosage rande for different ages
- How often it can be safely taken
- Route or method of administration
- Factors that may affect efficacy, like “take with food”
- Pregnancy/nursing
- Sodium and other electrolyte content
Drug Facts Label (1999)
What are the components of the standard order created for non-Rx products under the Drug Facts Label (1999)?
- Active Ingredients
- Purpose
- Uses
- Warnings (“ask your doctor or pharmacist about food or drug interactions”)
- Directions
- Other information
- Inactive ingredients
Reqs have been established for pregnancy and Na/other mineral content
Prescriptions for OTCs
Pharmacists can refill OTCs without prescriber authorization, unless what?
- Dose requested is greater than the recommended amount on OTC label
- Prescriber limited the refills on the original Rx
- Schedule V drug where refills must be designated by the prescriber
- Individual state has set time limit for refills
Nonprescription Drugs
Even if a non-Rx is dispensed & profiled as an Rx, it does not need to be treated like a true Rx in regards to counseling and labeling
True or False
False - must be treated in all respects like a prescription with counseling and labeling
Nonprescription Drugs
If a non-Rx is sold in its original, unbroken prepackaged container, then it does not need to be dispensed & profiled as an Rx.
True or False
True
CV Prescriptions
What is the scheduling definition of schedule V products? What are examples of CV products?
- Drugs that have an accepted medical use; low potential for abuse relative to CIVs; may lead to LIMITED physical & psychological dependence
- Dihistine and Dihistine DH (cough & cold)
- Lonox (diphenoxylate & atropine)
CV Prescriptions
CV Rxs may be written or verbal orders OR may be dispensed without a prescription
True or False
True
Dispensing CVs by Pharmacists
CV sales transactions can be handled by a non-pharmacist employee, but CV distribution must only be done by a pharmacist
True or False
True - “not even an employee under the supervision of a pharmacist”
Dispensing CVs by Pharmacists
What are the liquid CV quantity limits per purchaser?
Liquid CV Sales
- 120 mL (4 oz) of any CV in a 48 hour period
- Pharmacist must determine the medical need for repetitive sales
Dispensing CVs by Pharmacists
The purchaser of a liquid CV product must meet what requirements?
- 18 years or older
- May not purchase substance again in any 48 hour period
- Must provide suitable ID if unknown to pharmacist
Dispensing CVs by Pharmacists
What must the record book for CV distribution include for each purchase?
- Name/address of purchaser
- Name/quantity of substance purchased
- Date of purchase
- Name or initials of pharmacist
Maintained by PHARMACIST
CMEA: Combat Methamphetamine Epidemic Act of 2005
What drug product active ingredients are included in the CMEA Act?
Ephedrine, Pseudoephedrine, Phenylpropanolamine
CMEA: Combat Methamphetamine Epidemic Act of 2005
Under the CMEA Act, what are the product storage requirements?
Behind counter or in locked cabinet
