Must a pharmacist signature accompy an application for a pharmacy permit?

Yes. Application for such permit shall be made on a form provided by the Board and signed by a pharmacist who will be in full and actual charge of the pharmacy and who will be fully engaged in the practice of pharmacy at the location designated on the application.

What must an application for a pharmacy permit entail in relatino to operational perameters?

(i) Show the coporate name and trade name

(ii) list any pharmacist in addition to the PIC practicing at the location indicated on the application

(iii) list the hours during which the pharmacy will be open to provide pharmacy services

Must the board of pharmacy be notified should the hours of operation change?

Yes.

Any change in the hours of operation, which is expected to last more than one week, shall be reported to the Board in writing and posted, at least fourteen days prior to the anticipated change, in a conspicuous place to provide notice to the public.

A pharmacy permit is actually given to whom?

The actual permit will be issued ONLY to the pharmacist who signs the application as the pharmacist-in-charge (PIC) and as such assumes the full responsibilities of the legal operation of the pharmacy.

What happens to the pharmacy permit once a PIC is terminated?

immediately surrended to the Board by the PIC or legal representative.

May a pharmacy that has failed to procure a PIC reamin in operation?

No. The pharmacy must properly dispose of all Schedule II through VI drugs and devices on the premises within 15 days.

Mus the PIC make an inventory of drugs upon hire?

Yes! Succeeding pharmcist-in-charge shall cause an inventory to be made of alll schedule I-V drugs on hand. Such inventory shall be completed as of the date he becomes pharmacist-in-charge and prior to opening for business on that date.

Whose respnosbility is to enact safeguards against diversion of all controlled substances?

The pharmacist to whom such permit is issued

When do pharmacy permits expire?

Annually on a date determined by the board

Prior to the closing of a pharmacy for more than ___ week, the owner shall either (i) post a conspicuous notice at least ____ days prior to the anticipated closing or (ii) mail a notice, at least _____ days prior to the anticipated closing, to every current pharmacy customer having refill authority.

When a pharmacy that is closing transfers their prescpriton informatin to the new owner, how far back must the records go?

How many pharmacies can one pharmacist be in charge of (i.e. how many permits can they have?)

Who is to controll all aspects of the pharmacy practice?

The pharmacist-in-charge (PIC) or the pharmacist on duty shall control all aspects of the practice of pharmacy.

Doe shte law require for the PIC to take a full and complete inventory of controlled substances II-V on the date of termination?

NO; it does not.

PIC has the option to unless the owner of the pharmacy submits written notice to the board showing good cause as to why this opportunity (seriously, opportunity?!) should not be allowed.

A PIC who is absent from practice for more than _____ consecutive days shall be deemed to no longer be the PIC.

30

Pharmacists-in-charge having knowlede of upcoming absences for longer than 30 days shall be responsible for notifying the board and returning the permit.

An application for a permit designating the new PIC shall be filled with the required fee within ____ days of the original date of resignation or temination of the PIC on a form provided by the board.

14;

It shall be unlawful for a pharmacy to operate without a new permit past the 14-da deadline unless the board receives a request for extension prior to the deadline. The executive director for the board may grant an extension for up to an additional ___ days for good cause shown. 

For good cause shown, the board may issue a special or limited-use pharmacy permit, when the scope, degree or type of pharmacy practice or service to be provided is of special, limited or unusual nature as compared to a regular pharmacy service.

What conditions must be met for a pharmacy to obtain a "Special or limited-use pharmacy permit"?

(1) list the regulatory requirements for which a waiver is requested and a brief explanation as to why each requirement should not apply to that practice.

(2) policy and procedure manual

(3) the understanding that the continuation of such permits shall be subject to continuing compiance with the conditions set forth by the board.

For a special-use pharmacy located in or providing services to a free clinic that uses volunteer pharmacists on a part-time basis with pharmacy business hours less than ____ hours a week, the board may grant waiver to the restricted access provisions under the following conditions (what are the conditions):

20;

(1) the access is only for the purpose of repairing or upgrading essential equipment for the purpose of securing a delivered drug order in the pharmacy

(2) The PIC shall be notified prior to each entry and give permission for the designated, specific individulas to enter

(3) If entry is by a nonpharmacist, two persons must enter together, one of whom must be an employee or volunteer of the free clinic who holds a license as a nurse, physician, or a physician assistant. Both persons must remain in the pharmacy the entire time that access is required.

(4) The key must be maintained in a secure location within the facility in a sealed envelope or other container with the name of the sealing pharmacist written across the seal. The PIC shall ensure that the alarm access code is changed within 48 hours should a nonpharmacist enter the pharmacy.

(5) A log must be maintained of each nonpharmacist enter showing date and time or entry, names of the two persons entering, purpose for entry, and notation that permission was granted by the pharmacist-in-charge and the date it was granted. Such a log shall be maintained on premises for one year.

Is the succeeding PIC required to take inventory of the drus on-hand?

Yes. The succeeding pharmacist-in-charge shall cause an inventory to be made of all Schedule I-V drugs on hand. Such inventory shall be completed as of the date he/she becomes pharmacist-in-charge and prior to opening for business on that date.

Any person wishing to open a new pharmacy, engage in the acquisition of an existing pharmacy, change the location of an existing pharmacy, move the location or make structural changes to an existing prescription department, or make changes to a previously approved security system shall file an application with the board.

In acquisition of a new pharmacy, if the prescription records are to be accessible to anyone for purposes other than for continuity of pharmac services at substantially the same level offered by the previous owner or for the necessary transfer of prescription recrods, the owner of the pharmacy acquiring the records shall disclose such information in writing to eachpatient ___ days prior to the acquisition.

Do proposed location or structural changes require board authorization?

Of course, in fact, it requires a new permit to reflect the location/structural changes.

Pharmacy permit appliations which indicate a requested inspection date, or requests which are received after the application is filed, shall be honored provided a ____ day notice is allowed piror to the requested inspection date.

14;

Requested inspection dates which do not allow a 14-day notice to the board mauy be adjusted by the board to provide 14 days for the scheduling of the inspection.

Penalty for not being prepared for inspection or failing an inspection?

Of course; the penality is a fee.

"If an appilcant substantially fails to meet the requirements for issuance of a permit and a reinspection is required, or if the applicant is not ready for the inspection on the established date and fails to notify the inspector or the board at least 24 hours prior to the inspection, the applicant shall pay a reinspection fee prior to reinspection being conducted."

Drugs shall not be stocked within the proposed pharmacy or moved to a new location until approval is granted by the inspector or board staff.

Once the permit is issued, prescription drugs may not be stocked earlier than ______ prior to the designated opening date. Once prescription drugs have been place in the pharmacy, a pharmacist shall be present on a daily basis to ensure the safety and integrity of the drugs (duh!).

Permits issued under the provisions of this chapter shall be displayed in a conspicuous place in the factory or other place of business for which issued.

Are permits transferable?

No. Permits shall not be transferable and shall be renewed annually.

Every pharmacy shall be under the personal supervision of a pharamcist on the permises of the pharmacy.

The PIC in a pharmacy located within a hospital or the PIC of any outside pharmacy providing pharmacy services to a hospital shall be responsible for establishing procedures for and assuring maintenance of the proper storage, security, and dispensing of all drugs used throughout the hospital.

The PIC of a pharmacy serving a hospital shall be responsbile for maintaining a policy and procedure for providing reviews of drug therapy to include at a minimum any irregularities in drug therapy consistent with the Code of Virginia.

Schedule VI controlled substances, the PIC of a pharmacy serving a hospital may authorized the storage in an area or the hospital outside the pharmacy, and may delegate the ordering and distribution within the hospital to non-pharmacy personnel provided the conditions for proper storage and adequate security and the procedures for distribution are set forth in the pharmacy's policy and procedure manual, and provided the PIC assures that these storage areas are checked ______ for compliance. The storage areas must be locked when authorized staff is not present in the area. Except for _____ _____, medical gases may be stored in an unlocked area.

The prescription department shall not be less than _____ square feet.

Access to stock rooms, rest rooms, and other areas other than an office that is exclusively used by the pharmacist shall not be through the prescription department.

A rest room in the prescription department, used exclusively by pharmacists and personnel assisting with dispensing functions, may be allowed provided there is another rest room outside the prescription department available to other employees and the public.

Yes. A sink with hot and cold running water shall be within the prescription department.

Is the PIC in charge of keeping a current dispensing information reference source consistent with the scope of pharmacy practice at the location of the permitted pharmacy?

The PIC is responsible for keepign a set of prescription balances, sensitive to _______, and weights or an electronic scale if the pharmacy engages in dispensing activities that require the weighing of components.

The PIC is responsible for other equipment, supplies, and references consistent with the pharmacy's scope of practice and with the public safety.

Define "Prescription department"

means any contiguous or noncontiguous areas used for the compounding, dispensing and storage of all schedule II through VI drugs and devices and any schedule I investigative drugs

What must the prescription department ensure when a pharmacist is not on duty

The enclosure shall be locked and alarmed at all times when a pharmacist is not on duty.

The keys or other means of entry into a locked prescription deparment and the alarm access code shall be restricted to pharmacists practicing at the pharmacy and authorized by the PIC with what exceptions?

(1) the PIC or a pharmacist on duty, for emergency access, may place a key or other means of unlocking the prescription department and the alarm access code in a seald envelope or other container with the pharmacist's signature the seal in a safe or vaut or other secured place within the pharmacy.

(2) Pharmacy interns, pharmacy technicians, and other persons authorized by the PIC or pharmacist on duty may posses a key or other means of entery into a locked prescription department only when a pharmacist is on duty.

Each pharmacist while on duty shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of prescription drugs and drugs.

Upon request by a patient to obtain an already-dispensed prescription, a pharmacy technician may enter the pharmacy for the sole purpose of retrieving filled precriptions that have already been reviewed and certified for accruacy by a pharmacist and deemed ready for delivery to the patient if?

(1) unplanned reason for pharmacist not to work

(2) Alternate pharmacist coverage cannot immediately be obtained

(3) The technicianis accompanied by a member of the pharmacy's management or administration

What are the requirements for entry into the prescription department in the absence of a pharmacist?

(1) prior to entry into the prescription department, the pharmacy technician shall obtain verbal permission from the PIC or another pharamcist regularly employed by that pharmacy to obtain and use the emergency key or other access and alarm access code and enter the pharmacy.

(2) Record shall be made by the pharmacy technician of the entry to include the date and time of entry; the name and signature of the pharmacy technician; the name, title, and signature of the person accompanying the pharmacy technician; the pharmacist's name granting permission to enter and telephone number where the pharamcist was reached; the name of the patient initially requesting needed medication and the nature of the emergency; a listing of all prescription retrieved during that entry; and the time of exit and re-securing of the prescription department.

(3) pharmacy technician shall reseal the key and alarm access code after the pharmacy is re-secured, and the PIC shall have the alarm access code changed within 48 hours of such an entry and shall document that this has been accomplished on the record of entry.

(4) All records related to entry by a pharmacy technician shall be maintained for a period of one year on permises.

Are prescription departments required by law to have a security system?

Yes. A device for the detection of breaking shall be installed in each prescription department of each pharmacy.

The device shall fully protect the prescription department and shall be capable of detecting breaking by any means when activated.

Are security alarms prior to November 4, 1993 inadequate?

Technicially, no. But if a break in does occur than the pharmacy is required to upgrade their security system witin 14 days!

Is a pharmacy that is opened 24 hours a day required to have a security system?

NO. If, however, the pharmacy changes its hours or if it must be closed for any reason, the PIC or owner muts immediately notify the board, file an application (with the board), and have installed prior to closing, a security system that meets the requirements.

Prescirptions awaiting delivery. Prescriptions prepared for delivery to the patient may be placed in a secured area outside of the prescription department, not accessible to the public, where access to the prescriptions is restricted to individuals designated by the pharmacist.

No. Schedule II drugs shall either be dispersed with other schedules of drugs or shall be maintained within a secrely locked cabinet, drawer, or safe. The cabinet, drawer, or safe may remain unlocked during hours that the prescription department is open and a pharamcist is on duty.

Can expired drugs be kept amongst the dispensing stock?

No. Expired prescription drugs shall be maintained in a designated area within the prescription department until proper disposal.

Any person who permits or causes, directly or indrectly, such controlled paraphernalia to be used for any other purpose thatn that for which it was lawfully obtained shall be guilty of ?

Any equipment outside the pharmacy used to house drugs to be administered in a unit dose system shall be fitted with a locking mechanism and locked at all times when unattended. True/False?

Regarding drug storage in long-term-care facilities, what are the pharmacist responsibilities?

(1) ensure that each cabinet, cart or other are utilized for the storage of drugs is locked and accessbiel only to authorized peronnel

(2) ensure that the storage are for patients' drugs is well lighted, or sufficient size to permit storage without crowding, and is maintained at appropriate temperature.

(3) ensure that poison and drugs for "external use only" are kept in a cabinet and separate from other medicaitons

When authorized by the PIC, an authorized _____ may have access to a supply of drugs maintained by the pharmacy at a location _____ the pharmacy in order to obtain emergency medication during hours the pharmacy is closed, prvoided that such drug is available in the manufacturer's original package or in units which hvae been prepared and labeled by a pharmacist and provided further that a serparate record shall be made and left at the location of the stock of drugs on a form prescribed by the PIC and such records are maintained witin the pharmacy for a period of ____ year.

Must the after-hours supply of drugs be monitered by a security system?

Depends. If the after-hours supply of drugs is in an area that is continuously open and staffed, such as a patient floor or emergency room, then the area does not need to be alarmed. If the after-hours supply is maintained in an area of the hospital that is not open continusouly staffed, such as a floor that primarily houses departments that are closed daily, then an alarm shall be installed.

At least ____ days prior to the date a pharamacy closes, the owner shall notify the board.

What should be reported to the board when a pharmacy closes?

Proposed disposition of all schedule II through VI drugs, prescription dispensing records, patient information records, and other required records.

At least ____ days prior to any change in owenership of an existing pharmacy, the owner shall notify the board of the pending change.

Upon any change in ownership of an existing pharmacy, the prescription dispensing records for the ____ years immediately preceding the date of change of ownership and other required patient information shall be provided to the new owners on the date of change of ownership in substantially the same format as previously used immediately prior to the transfer to provide continuity of pharmacy services.

Who is responsible for record transfer?

The previous owner shall be held respnsible for assuring the proper and lawful transfer of records on the date of the transfer.

Is the PIC in charge of providing notice to the public of a change in pharmacy operations?

No. The OWNER of the pharmacy shall be responsible for providing notice for a change in the hours of operation to the public and to the board.

Within houw many days must the board be notified in the change in hours of operation?

What does the DEA number consists of?

Two letter combination followed by a seven number combination.

What DEA letters corrispond to practitioners and dispensers!

A, B, F

Mid-level practitioners receive DEA numbers with what letters?

Distributors receive DEA numbers beginning with what letters?

The second letter of the DEA number noramlly begins with what?

How to check the legitimacy of a DEA number!

(1) Add the first, third and fifth digits of the seven numbers that follow the first two letters

(2) Then add the second, fourth and sixth of those seven numbers, double the result and add this figure to the first sum

(3) Compare the number in the “ones column” of the result (the right-most digit) and determine whether this number matches the seventh and final number of the nine-figure letter-and-number combination.

If there is a match, then the DEA number looks valid

Law enforcement personnel, agents and employees of registrants, and certain military and other personnel are exempt from registration.

Only persons actually engaged in activities with controlled substances are required to register

a pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding _____ of the complete solution, compound or mixture without the need to register as a manufacturer.

Pharmacists is that they may distribute controlled substances to other registrants, as long as the total number of dosage units does not exceed ___ percent of the total units of controlled substances distributed and dispensed in one year, without the need to register as a distributor!

Pharmacist must keep accurate records of controlled substances and where they are going at all times. Are prescribers required to?

Prescribers are not required to keep records if they simply prescribe or administer drugs in the course of their practice, and do not dispense them!

What is the purpose of the DEA number?

To account for the regulation of controlled substances!

Therefore ALL controlled substance prescriptions must have a DEA number!

The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to
each healthcare provider.

When a pharmacy is closing, who is responsible for the transfer of controlled substances?

The pharmacy is responsible for the actual
transfer of the controlled substances and for the accuracy of the inventory and records. The records involving the transfer of controlled substances must be kept readily available by the pharmacy for two years for inspection by the DEA.

The logistics of transfering CIII-CV substances from a closing pharmacy to a new pharmacy?

To transfer schedule II substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances.

Who may have access to and make copies of records?

Agents designated by the Board and any agent designated by the Superintendent of the Department of State Police!

Can an agent of the Superintendent of the Department of State Police copy/remove records from the premises?

Depends. Generally, no.

"Any agent designated by the Superintendent of the Department of State Police to conduct drug diversion investigations shall, for the purpose of such investigations, also be permitted access at reasonable times to all such records relevant to a specific investigation and be allowed to inspect and copy such records. However, agents designated by the Superintendent of the Department of State Polic to conduct drug diversion investigations shall not copy and remove patient records unless such patient recrods are relevant to a specific investigation."

If records are removed fro the permises by an agent, waht must be left behind?

A receipt.

Can an agent take financial data?

"No inspection shall extend to financial data, sales data other than shipment data, pricing data, personnel data or resesarch data"

Can a DEA registration be modified?

Can a DEA registration be modified to add authority to more controlled substances, including controlled I substances?

Yes;

"If the registrant is seeking to handle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, he/she shall attach three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate. No fee shall be required to be paid for the modification."

How early can one register for renewal of a DEA registration?

Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II controlled substances or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration.

How long does a DEA registration last (for retail pharmacy, hospital/clinic, practitioner or teaching institution is first registered) lasts?

36 months (three years)

What DEA form should be filed to surrender a DEA registration?

In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.

What is the time frame for an outgoing business to notify the DEA of transfer of controlled substances to a new business. And what information must be included?

Any registrant desiring to discontinue business activities altogether or with respect to controlled substance (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information:

(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);

(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);

(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will occur.

What the requirement for the transfer of controlled substances between a closing pharmacy and the buying pharmacy so that the closing pharmacy is not classified as a manufacturer?

Unless the registrant-transferor is informed by the Special Agent in Charge, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his/her possession to the registrant-transferee in accordance with the following:

(1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Administration unless requested by the Special Agent in Charge. 

 

(2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under part 1304 of this chapter, shall be transferred to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.

Note: remember that the movement of controlled substances (I and II) require DEA form

If the DEA enters into the pharmacy and takes a sample of a controlled sample or listed chemical, what DEA form must they give as a receipt?

What information is excluded from DEA inspection?

(1) Financial data3

 

(2) Sales data other than shipping data

(3) Pricing data

The DEA must obtain an adminstrative warrant to inspect one's property agains the consent of the owner. Is this always true?!

No; there are exceptions!

Does the owner of the pharmacy have to consent to inspection and, if so, how is it done?

Yes.

Wherever possible, informed consent shall consist of a written statement signed by the owner, operator, or agent in charge of the premises to be inspected and witnessed by two persons. The written consent shall contain the following information:

(1) That he (the owner, operator, or agent in charge of the premises) has been informed of his constitutional right not to have an administrative inspection made without an administrative inspection warrant;

(2) That he has right to refuse to consent to such an inspection;

(3) That anything of an incriminating nature which may be found may be seized and used against him in a criminal prosecution;

(4) That he has been presented with a notice of inspection as set forth in Sec. 1316.06;

(5) That the consent is given by him is voluntary and without threats of any kind; and

(6) That he may withdraw his consent at any time during the course of inspection.

(c) The written consent shall be produced in duplicate and be distributed as follows:

(1) The original will be retained by the inspector; and

(2) The duplicate will be given to the person inspected.

Can an owner refuse a DEA inspector who posses an adminstrative warrant?

Sure, do so and be arrested and be removed from the premises :-)

Can someone with a history of a felony be hired to work with controlled substances?

NO!

"The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term "for cause" means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances."

What DEA form is used to order Schedule II drugs?

What DEA form is used for inventory surrenderd?