DRUG POLICY AND PROCEDURE MANUAL FOR STORM PLACE 6
DrugPolicy and Procedure Manual for Storm Place Student`snameinstitution
Stormsplace drug storage facility shall
1.Be of suitable size, constructed to facilitate cleaning maintenanceand proper operations
2.Provide adequate lighting, ventilation, temperature, sanitationhumidity, space, equipment and security conditions.
3.Have a quarantine area that is designed for storage of outdated,deteriorated, adulterated, outdated , misbranded, immediate/ sealedsecondary containers that have been opened
4.Be maintained in clean and orderly condition
5.Be free from infestation by insects, birds, rodents, insects orvermin of any kind
6. Be secure from unauthorized access as follows:
Access from outside of the premises shall be kept to a minimum and well controlled
Entry into drug storage area shall be limited to authorized personnel only
Outside perimeter shall be well lighted
Storage area shall be fitted with a security alarm system that detects after hour entry and
Storage area shall be equipped with a security system to protect against theft or diversion aimed at tampering with computers or electronic records.
8.All drugs shall be stored at the desirable temperatures and theappropriate conditions as provided by the requirements if any,with the labeling of such drugs and
9.If there are no storage requirements for a prescription drug, itshall be held at a controlled room temperature to ensure that itsstrength identity quality and purity are not adversely affected (FDA,2011)
Stormsplace drugs shall be administered as follows:
1.The oldest and approved stock of drugs shall be distributed first.Any deviation from this policy shall be temporary and appropriate
2.The procedure of handling recalls and withdrawals shall be adequatewith regards to
Any action that is initiated at the request of the food and drug administration or other federal, state, or local law enforcement, government agency including the state licensing agency.
Actions undertaken by the manufacturer to remove defective or potentially defective drugs from the market and
Any action undertaken to promote public health and safety that includes replacement of the current merchandise with improved products or new package design.
3.Outdated drugs at storms place shall be separated from other drugsand either returned to the
Manufactureror destroyed. There shall be shall be a written documentation of thestatus of the destroyed drugs which shall be maintained for 2 yearsafter their disposal and
4.Storms administration shall provide a list of the people responsibleof drug handling and storage including a detailed description oftheir duties and a summary of their qualifications (Hilts, 2003).
5.Before transportation, each outside container shall be visuallyexamined for identity to prevent the acceptance of contaminatedprescription drugs that are otherwise unfit for transportation
6.The examination shall be aimed at revealing containerdamage that would suggest possible contamination or other damageto the contents and
7.Before transportation, there shall be a careful inspection to ensurethere is no delivery of drugs that have been damaged while in storageor held under improper conditions (FDA, 2011).
1.Storms place labeling procedures shall be in tandem with the recordkeeping requirements with regards to labeling of all outdated,damaged, deteriorated, misbranded or adulterated prescription drugs
2.Labeling procedures shall be administered during receipt of the drugsto ensure security, storage, inventory and distribution ofprescription drugs and
3.Labeling shall be aimed at enhancing identification, recording andreporting losses or thefts and for correcting all errors andinaccuracies in inventories (Hilts, 2003).
E.Disposal over the counter
Stormsplace shall establish and maintain records and inventories of alltransactions with regards to disposal over the counter. The recordsshall entail:
1.The identity and quantity of the drugs disposed over the counter
2.The dates of disposal over the counter and of receipt of the drugs
3.The records regarding disposal over the counter that shall be madeavailable for inspection and photocopying by the law enforcementagency officials for a period of three years after their date ofcreation
4.The records regarding disposal that shall be kept in the inspectionsite where they can be easily retrieved by computer or otherelectronic means. They shall be easily available for authorizedinspection during the retention period
Disposal records kept at central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request from an authorized official of the State or a law enforcement agency.
5.The destination of the drugs, including the name and principaladdress of the buyer and the location and the address to which thedrugs were shipped and
6.The source of the drugs, including the name and principal address ofthe seller or transferor and the location and the address from whichthe drugs were shipped (FDA, 2011).
E.Staffing responsibilities and emergency supplies such as Epi-pen,inhaler and insulin
1.Storms place staff shall be responsible for enacting procedures toprepare against and handle any emergency supplies such as Epi-pen,inhaler and insulin including crisis that affects security of thedrugs in the event of fire, floods and any natural disasters orsituations of local, state or national emergency.
2.Storms place staff shall allow the state licensing authority andauthorized federal, state and local enforcement officials to enterand inspect the storms place premises, to audit the records and thewritten operating procedures at reasonable times, in a reasonablemanner to the extent authorized by law.
Hilts,P. (2003). ProtectingAmerica`s health: The FDA, business, and one hundred years ofregulation.New York: Alfred A. Knopf.
Medicaldevices and the public`s health the FDA 510(k) clearance process at35 years.(2011). Washington, D.C.: National Academies Press.