NMBOP: 35 & 37 Flashcards
PART 35 DRUG WAREHOUSE
“Drug warehouse”
means an off-site physical storage location of a clinic, hospital or pharmacy currently licensed by the New Mexico board of pharmacy. Dangerous drugs may be stored for the use of the licensed clinic, hospital or pharmacy.
FACILITIES
Q: What are the general requirements for facilities where prescription drugs are stored?
A: Facilities must be of suitable size and construction to facilitate cleaning, maintenance, and proper operations. They must be maintained in a clean and orderly condition, be free from infestation by insects, rodents, birds, or vermin of any kind, and be a commercial location, not a personal dwelling or residence.
FACILITIES
Q: What specific features must storage areas in these facilities have?
A: Storage areas must provide adequate lighting, ventilation, temperature control, sanitation, humidity control, space, equipment, and security. They must also include a quarantine area for storing prescriptions that are outdated, damaged, deteriorated, misbranded, counterfeit, suspected of being counterfeit or adulterated, or otherwise unfit for use.
FACILITIES
Q: How should controlled substances be stored in comparison to non-controlled substances?
A: Controlled substances must be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.
FACILITIES
Q: What inventory controls must facilities implement?
A: Facilities must provide and maintain appropriate inventory controls to detect and document any theft, counterfeiting, or diversion of prescription drugs or devices.
STORAGE
Q: How should all prescription drugs be stored?
A: All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements specified in the labeling of such drugs or in compliance with standards in the current edition of an official compendium, such as the United States Pharmacopeia-National Formulary (USP/NF).
STORAGE
Q: What should be done if no specific storage requirements are established for a prescription drug?
A: If no requirements are established, the drug may be held at “controlled” room temperature, as defined in an official compendium, to ensure that its identity, strength, quality, and purity are not adversely affected.
STORAGE
Q: What equipment should be used to document proper storage of prescription drugs?
A: Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be utilized to document proper storage of prescription drugs.
SECURITY
Q: How should facilities used for drug warehouses be secured from unauthorized entry?
A: All facilities used for drug warehouses shall be secure from unauthorized entry by ensuring:
1. Access from outside the premises is kept to a minimum and well-controlled.
2. The outside perimeter of the premises is well-lighted.
3. Entry into areas where prescription drugs are held is limited to authorized personnel.
SECURITY
Q: What security systems must all facilities have to protect against theft, diversion, or counterfeiting?
A: All facilities shall be equipped with a security system that provides suitable protection against theft, diversion, and counterfeiting, including:
1. An alarm system to detect entry after hours.
2. A security system to protect against theft and diversion.
3. Protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
EXAMINATION OF MATERIALS
Q: What should be done upon receipt of each outside shipping container?
A: Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that could suggest possible contamination, adulteration, misbranding, counterfeiting, contraband, or other damage to the contents.
EXAMINATION OF MATERIALS
Q: What inspection procedures should be followed for outgoing shipments of prescription drugs?
A: Each outgoing shipment shall be carefully inspected for the identity of the prescription drug products and to ensure that no prescription drugs that have been damaged in storage or held under improper conditions are delivered.
EXAMINATION OF MATERIALS
Q: What must a drug warehouse do upon receipt of prescription drugs or devices?
A: Upon receipt, a drug warehouse must review records for the acquisition of prescription drugs or devices to ensure accuracy and completeness.
RECORD KEEPING
Q: What records must drug warehouses establish and maintain?
A: Drug warehouses shall establish and maintain inventories and records of all transactions regarding receipt, distribution, or other disposition of prescription drugs. These records must include:
1. The identity and quantity of the drugs received and distributed or disposed of;
2. The dates of receipt and distribution or other disposition of the drugs;
3. The name, location, and license number of the business, health care practitioner, or other entity appropriately licensed to possess, dispense, distribute, administer, or destroy prescription drugs.
RECORD KEEPING
Q: How long must inventories and records be maintained, and who can inspect them?
A: Inventories and records must be maintained for a retention period of three (3) years following the disposition of the drugs. These records must be made available for inspection and photocopying by authorized inspectors employed by the board and authorized federal, state, or local law enforcement agency officials.
RECORD KEEPING
Q: What must registrants do to store records at an alternate location?
A: Registrants must petition the board for a waiver to store records at an alternate location. The petition must include the address (mailing and street), telephone number, and the name and title of the person designated as the custodian of the records. Any changes in custodian or location of records must be reported in writing to the board within fifteen (15) actual days. Records approved by waiver to be stored at an alternate location must be available within two (2) working days of a request by authorized board personnel or officials of a federal, state, or local law enforcement agency.
Q: What actions must drug warehouses take regarding theft or loss of prescription drugs?
A: Drug warehouses shall report any theft, suspected theft, diversion, or other significant loss of any prescription drug or device to the board and FDA, and where applicable, to the DEA.
WRITTEN POLICIES AND PROCEDURES
Q: What must drug warehouses establish, maintain, and adhere to according to written policies and procedures?
A: Drug warehouses must establish, maintain, and adhere to written policies and procedures for:
1. The receipt, security, storage, inventory, and distribution of prescription drugs.
2. Identifying, recording, and reporting losses or thefts.
3. Correcting all errors and inaccuracies in inventories.
WRITTEN POLICIES AND PROCEDURES
Q: What specific procedures must be included in the written policies and procedures of drug warehouses?
A: Drug warehouses must include the following procedures:
1. A procedure for distributing the oldest approved stock of a prescription drug product first. Deviations are allowed if temporary and appropriate.
2. A procedure for handling recalls and withdrawals of prescription drugs, including:
- Actions initiated by the FDA or other federal, state, or local agencies.
- Voluntary actions by the manufacturer to remove defective drugs.
- Actions to replace existing merchandise with improved products or new package designs.
3. A procedure to prepare for, protect against, and handle crises affecting security or operations, including strikes, fires, floods, or other emergencies.
4. A procedure to segregate outdated prescription drugs from other drugs, return them to the manufacturer or destroy them, and provide written documentation of this disposition for three (3) years.
5. A procedure for the destruction of outdated prescription drugs in accordance with state and federal laws, including necessary documentation and witnessing of destruction, maintained for a minimum of three (3) years.
6. A procedure for disposing and destroying containers, labels, and packaging to prevent counterfeiting activities, including documentation and witnessing of destruction, maintained for a minimum of three (3) years.
7. A procedure for reporting criminal or suspected criminal activities involving prescription drug inventory to the board, FDA, and if applicable, DEA, within three (3) business days.
16.19.35.14 RESPONSIBLE PERSONS: Drug warehouses shall
establish and maintain lists of officers, directors, managers and other persons in charge of drug warehouse storage and handling, including a description of their duties and a summary of their qualifications.
COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW
Q: What access rights do board authorized personnel and authorized federal, state, and local law enforcement officials have at drug warehouses?
A: Drug warehouses must permit board authorized personnel and authorized federal, state, and local law enforcement officials to:
- Enter and inspect their premises and delivery vehicles.
- Audit their records and written operating procedures.
- This access must be provided at reasonable times and in a reasonable manner, and officials must show appropriate identification before being permitted access.
COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW
Q: What are the registration and compliance requirements for drug warehouses dealing in controlled substances?
A: Drug warehouses dealing in controlled substances must:
- Register with the board and the DEA.
- Comply with all applicable state, local, and DEA regulations.
COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW
Q: To whom may a licensed drug warehouse distribute prescription drugs?
A: A licensed drug warehouse may distribute only to persons who are licensed to possess dangerous drugs.
COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW
Q: Who can controlled substances be distributed or delivered to within the state?
A: Controlled substances may only be distributed or delivered to persons in this state who are registered by the board and the DEA to possess controlled substances.
MINIMUM REQUIRED INFORMATION FOR DRUG WAREHOUSE LICENSURE
Q: What must every clinic, hospital, or pharmacy requiring off-site storage of drugs do to obtain a license from the board?
A: They must:
- Apply to the board and provide the required information on an application approved by the board, including:
- All trade or business names used by the licensee.
- Names and details of owners and operators.
- Details about the type of business entity (partnership, corporation, sole proprietorship, LLC).
- Designated representatives for each facility.
- List of all state and federal licenses, registrations, or permits.
- List of disciplinary actions against the distributor.
- Description of each facility and warehouse.
- Copy of the drug warehouse written policies and procedures.
