Questions and Answers
May an automated dispensing device be used as an 'emergency kit'?
True
A pharmacy that services a nursing home may install an automated dispensing device to dispense controlled substances at the nursing home.
True
Does the NC Board of Pharmacy conduct background checks on licensees and registrants?
True
When do Board meetings occur?
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How can I present an issue to the Board of Pharmacy?
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How long should a pharmacist keep a hard copy of the Board's Newsletter?
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How should a pharmacy engage in compounding report to the Board?
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Is adding flavoring to a conventionally manufactured product considered compounding?
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Is it permissible to compound domperidone?
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Must a prescription label state the drug's generic name?
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What is the formulation for UNC Hospitals Mucositis Mixture, also known as 'Sleepy Butter'?
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Study Notes
Automated Dispensing Devices
- Automated dispensing devices can be utilized as "emergency kits" in facilities with a pharmacy permit.
- In health care facilities without a pharmacy permit, devices can serve solely as an "Auxiliary Medication Inventory."
Automated Dispensing for Nursing Homes
- Pharmacies servicing nursing homes can install automated dispensing devices (e.g., Pyxis) for controlled substances only if the facility holds a pharmacy permit.
- A limited service permit is necessary for long-term care facilities to use automated dispensing systems.
- Pharmacies may need to obtain an additional DEA registration to operate these systems at long-term care facilities.
Background Checks
- The North Carolina Board of Pharmacy performs background checks on licensees and registrants.
Board Meeting Schedule
- Board of Pharmacy meetings occur monthly at 9 am on the third Tuesday, excluding August and December.
Presenting Issues to the Board
- Requests to present issues must specify the topic, include supporting materials, and state any desired action.
- Submissions must be received at least two weeks before the intended meeting date for consideration.
Newsletter Retention
- Pharmacies are required to maintain hard copies of the Board's Newsletter indefinitely.
Compounding Reporting Requirements
- Pharmacies with a permit from the NC Board of Pharmacy must report any compounding activities during initial application and annual renewal.
- Required information includes:
- Whether compounding occurs
- Estimated percentage of compounded products
- Engagement in non-sterile and sterile compounding
- Risk level of sterile compounding based on USP guidelines.
Flavoring Addition and BUDs
- Adding flavoring to a manufactured product is considered compounding.
- BUD (beyond use date) is typically 14 days refrigerated for products without preservatives and 35 days for those with preservatives, unless otherwise stated in manufacturer labeling.
- Document flavoring details in prescription records.
Compounding of Domperidone
- Compounding of domperidone is only allowed as part of an investigational new drug application (IND).
Prescription Labeling
- Prescription labels must include the drug's generic name.
- Compounded products should list all active ingredients, with exceptions for standard formulations like "Duke's Mouthwash."
UNC Hospitals Mucositis Mixture (Sleepy Butter) Formulation
- Ingredients include:
- Diphenhydramine liquid 2.5 mg/mL
- Maalox suspension or equivalent
- Lidocaine, viscous 2%
- Equal volumes of the ingredients are mixed, typically yielding 300 mL.
- Oral formulations must have a BUD of no longer than 14 days under refrigeration.
- Topical and mucosal formulations have a BUD of 30 days at room temperature.
- Administration directions vary between "swish and swallow" for oral and "swish and spit" for mucosal.
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Description
Test your knowledge of the North Carolina Board of Pharmacy regulations with these flashcards. This quiz includes questions about automated dispensing devices and their use in emergency situations, as well as guidelines for pharmacies servicing nursing facilities.
