The Pharmacy - Physical Space Flashcards
Specific Physical Space Requirements on Who Can Access Pharmacy? Without Pharmacist? Board of Pharmacy? Police?
- Must be locked by key or combination while pharmacist in charge is absent.
- Absence Under 2 Hours: Only pharmacist in charge may designate a staff in charge during absence.
- Board of pharmacy may perform compliance inspections.
Minimum Square Footage of Pharmacy?
No Minimum Square Footage
Minimum Counter Space of Pharmacy?
No Minimum Counter Space
Pharmacy Counseling Area Requirements?
Suitable for Confidential Patient Counseling:
* Easily accessible without allowing patient access to drugs
* Maintains confidentiality and privacy of pharmacist-patient communication
Pharmacy Security System Requirements?
Security:
* Pharmacist is responsible for prescription department while on duty. This includes: control against theft/diversion or unauthorized access to prescriptions, drug records, and patient records.
* If you have an authorized controlled substance collection program, federal regulations can be found at www.deadiversion.usdoj.gov/drug_disposal/drug-disposal.html under Title 21-1317. Must submit one copy of DEA Form 41 to special agent. If disposing regularly, Special Agent in Charge may authorize disposal without prior application if they keep records of disposals and file periodic reports summarizing disposals. Special agent may put conditions they deem as proper regarding disposal of controlled substances.
Department Locked:
* Lock by key/combination
* Pharmacist temporary absence (less than 2 hours) requires to designation of one staff member to be in charge. They may not dispense or provide final verification for drugs until the pharmacist returns.
* Pharmacist on break requires designation of one staff member to be in charge. They may not dispense drugs that require counseling until the pharmacist returns. May dispense refills that do not require counseling.
Secure Barrier:
* Must be surrounded by physical barrier that cannot be easily removed, penetrated, or bent.
* Physical barrier must be capable of being locked to prevent entry while the department is closed.
Minimum Requirements:
* Each Iowa pharmacy can make policies/procedures for physical security and monitoring to prevent unauthorized access to prescription drugs, including controlled substances, and pharmacy records. Must have an alarm and video surveillance system.
Telepharmacy:
* Electronic keypad or other electronic entry system into site that documents unique ID, date, and time.
Specifications on Pharmacy Alarms/Video Surveillance?
Policies/Procedures establish the retention of documentation of activities or recordings retained from alarm and video surveillance systems, as well as contingencies when systems are temporarily unavailble
* No later than July 6, 2023: a basic alarm system
* No later than July 6, 2023: a video surveillance system, except in areas where drugs are stored in an automated medication system or alternative electronic storage unit if it uses biometric restricted access or another electronic monitoring mechanism (like a badge).
* Controlled access to computer records
* Designated, monitored place to store personal staff items, away from drug storage and handling areas.
Pharmacy Connectivity Required? (Phone/Fax/Internet)
Not Specified
Separate Storage in Pharmacy for Physical Hard Copies by Control? Drugs by Control?
Hard Copies:
* CI/CII: Store Separately
* CII/CIII/CIV/CV: Store separately or in a form that is readily retrievable from ordinary business records.
Combined Records:
* If Controlled, Rx, or Non-Rx drugs are listed on same record; note the controlled substance in a form that is readily identifiable from other records (asterisked, red-lined, etc.)
Separate Storage of Drugs:
* Not specifically addressed unless controlled, then it must be secured in a locked storage area or in a way that discourages theft and diversion.
Must Pharmacy Storage Area Be Locked for Hard Copies? Drugs?
Hard Copies:
* Must be in secured storage area.
Drugs:
* CI: Store in a securely locked cabinet/safe.
* CII/CIII/CIV/CV: Store in securely locked cabinet/safe. (However, pharmacies/hospitals may disperse these substances throughout the stock of non-controlled substances in a manner to obstruct the theft or diversion of controlled substances.)
Must Pharmacy Storage Area be On Site for Hard Copies? Drugs?
Controlled Substance Hard Copies:
* Maintained in readily retrievable manner. (Federal Requirements 21 CFR 1304.04(g) & 657-10.36).
* Maintain records on-site or off-site in a secure storage area for minimum of 12 months, except if if the pharmacy has received an electronic copy that is immediately available.
* After 1 year, original records may be maintained off-site in secure storage for a minimum of 2 years.
* Original records and electronic records must be available within 72 hours by request of he board, or it’s authorized agent, unless such remote storage is prohibited under federal law (657-6.16).
