AZ Law.Lecture. 3.16 Arizona.CSA

Question 1

Every person who:

Must first: obtain and possess a current license or permit as a medical practitioner, or as pharmacy, pharmacist, manufacturer, or as a wholesaler

Answer 1

manufactures, distributes, dispenses, prescribes, or uses for scientific purpose any controlled substance s or proposes to do so

Question 2

Medical practitioner means:

Answer 2

any medical doctor, doctor of osteopathy, dentist, podiatrist, veterinarian or other person licensed and authorized by law to use and prescribe drugs and devices for the treatment of sickness in human beings or animals in this state or any state, territory, or district of the US

Question 3

Who doesn’t need to register for a current license or permit?

Answer 3

pharmacists unless they have a collaborative practice agreement that involves prescribing then they need to register.

Question 4

Az- inventories records are kept for?

Answer 4

3 years

Question 5

When does Az require an inventory of CS

Answer 5

Annual inventory on May 1 of each year or as directed by Arizona SBOP and under special circumstances

Question 6

When does Az require an inventory of CS under what special circumstances?

Answer 6

Specific inventory circumstances:

• Opening new pharmacy
• When there is a change of ownership or discontinuance of business; or you take CS stock from a pharmacy that is closing/terminating business
• Within ten days of a change of a pharmacist in charge
• If state board directs you to

Question 7

What are the inventory regulations?

Answer 7

• Include exact count of all CII
• Exact count of CIII-V or an estimated count if the stock container contains less than 1001 units.
• Indicate the date the inventory is taken and whether taken before opening or close of business for the pharmacy
• Be signed by the PIC OR for other required inventories the pharmacist who does the inventory
• Kept separately from other records
• Be available for inspection by the Board or its designee for not less than 3 years

Question 8

If a pharmacy is going out of business, and you are taking over their stocks including CII what form do you fill out?

Answer 8

Form 222

Using DEA Form 222 to transfer Schedule II Drugs

Question 9

Change in PIC you should do what?

Answer 9

inventory must be taken in 10 days!

Question 10

Federal inventory trigger for an inventory that is not in state trigger?

Answer 10

When a drug changes a schedule

Question 11

What happens when there is a loss of CS?

Answer 11

shall be reported:

• within 10 days
• DEA form 106
• By PIC or a manufacturer
• By the permittee or designated representative of a full-service wholesaler and
• to the federal DEA, the narcotic division of the DPS, and the board of pharmacy
  - Copy of the DEA Form 106 shall be kept on file by the pharmacy permittee, and shall state whether the police investigated the loss.

Question 12

How does loss of CS differ from Federal Vs.

Az

Answer 12

Federal requires you to report within 1 day

- loss is contextual…depends on the type of pharmacy (small or large)

Question 13

records of registrants…

Every person receiving… shall record and retain for not less than 3 years

Answer 13

Every person receiving, selling, delivering, or disposing of any controlled substance

Question 14

Records of registrants: should record and retain what for 3 years?

Answer 14

• The name, strength, dosage form, and quantity of each controlled substance received, sold, delivered, or disposed
• The name, address, and DEA registration number of the person from whom each controlled substances is received
• The name address and DEA registration number of the person to whom each controlled substance is sold, or delivered, or who disposes of each controlled substance, AND
• The date of each transaction

Question 15

What is not listed in the records of registrants?

Answer 15

Dispensing

however dispensing info must match inventory records.

Question 16

When should a drug wholesaler permitter or designated representative shall complete an inventory of all of the controlled substances?

Answer 16

• On May 1 of each year as directed by the board AND
• If there is a change in ownership, or discontinuation of business or within 10 days of a change of a designated
  representative

Question 17

controlled substances in schedule I and II shall be distributed by a registrant to another registrant only
pursuant to an order form?

Answer 17

Order from 222

Question 18

Closing a pharmacy what should happen to the paper form 222

Answer 18

The owner before they close up the pharmacy should send the paper form 222 back to the DEA regional office

Question 19

What should a prescription order contain?

Answer 19

(1) contain the date it was issued,
(2) the name and address of the person for whom or owner of the animal for which the drug is ordered,
(3) refills authorized, if any,
(4) the legibly printed name, address and telephone number of the prescribing medical practitioner,
(5) the name, strength, dosage form and quantity of the drug ordered and
(6) directions for its use.

Question 20

What if it is a written prescription?

Answer 20

Along with the other requirements, the written prescription should contain a manual signature of prescriber

Question 21

What if it is a controlled substance prescription?

Answer 21

Besides all the normal requirements, it should contain

• DEA registration number of the prescriber
• A prescription for a CII shall only contain one drug order per prescription blank

Question 22

what should a prescription order that is dispensed by the pharmacist include?

Answer 22

a. Date of issuance;
b. Name and address of the patient for whom or the owner of the animal for which the drug or device is dispensed;
c. Drug name, strength, and dosage form or device name;
d. Name of the drug’s or device’s manufacturer or distributor if the prescription order is written generically or a substitution is made;
e. Prescribing medical practitioner’s directions for use;
f. Date of dispensing;
g. Quantity prescribed and if different, quantity dispensed;
h. For a prescription order for a controlled substance, the medical practitioner’s address and DEA number;
i. For a written prescription order, the medical practitioner’s signature;
j. For an electronically transmitted prescription order, the medical practitioner’s digital or electronic signature;
k. For an oral prescription order, the medical practitioner’s name and telephone number; and
l. Name or initials of the dispensing pharmacist;

Question 23

if authorized verbally by the prescriber, the pharmacist may make changes to a written or electronic CII. But what is something they can not change!?

Answer 23

• patient’s name
• prescriber’s name
• drug name

Question 24

What should pharmacist document when it comes to changing a CII with verbal authorization from prescriber?

Answer 24

the pharmacist must document on the original prescription order, the change that were made pursuant to verbal authorization and
record the TIME and DATE the authorization was granted

Question 25

All CII OPIOIDS prescriptions may be dispensed only?

Answer 25

ONLY with an electron prescription
Exceptions:
- if the electronic system isn’t operational or available, the pharmacist may dispense a CII opioid- MUST KEEP A RECORD OF WHEN ELECTRONIC PRESCRIBING SYSTEM IS NOT OPERATIONAL OR
AVAILABLE IN A TIMELY MANNER
- the CII is in writing and indicates the practitioner who issued with prescription provided care for a patient in a VA facility, a health facility on a military base, an IHS or tribal facility.
-the requirement for an electronic prescription order does not apply to a prescription order for a schedule II controlled substance that is an opioid that is issued for medication-assisted treatment for a substance use disorder.

Question 26

A prescription order for a schedule II substance shall not be dispensed more than?

Answer 26

90 days after the date on which the prescription order

was issued

Question 27

What are the prescribing limits under the arizona’s arizona opioid epidemic act?

Answer 27

• initial prescription for a schedule II opioid to a five-day supply, (except an initial opioid prescription following a surgical procedure is limited to a 14-day supply)
• new prescription for a schedule II opioid can’t exceed 90 morphine milligram equivalents (MMEs) per day. (same exceptions but includes hospitalization
• pharmacist is not required to verify with the prescriber whether the initial prescription complies with this section or that the prescription meets the 90 MME per day
• If a patient is prescribed more than ninety morphine milligram equivalents per day, the prescriber shall also prescribe for the patient naloxone hydrochloride or any other opioid antagonist that is approved by the United States food and drug administration for the treatment of
  opioid-related overdoses.

Question 28

What are the exceptions to arizona’s arizona opioid epidemic act?

Answer 28

patient:
1. has an active oncology diagnosis
2. has a traumatic injury, not including a surgical procedure
3. is receiving hospice care
4. is receiving end-of-life care
5. is receiving palliative care
6. is receiving skilled nursing facility care
7. is receiving treatment for burns
8. is receiving medication-assisted treatment for a substance use disorder
9. is an infant who is being weaned off opioids at the time of hospital discharge

Question 29

In an emergency, can emergency quantities of schedule II substance be dispensed on an oral prescription order of a medical practitioner?

Answer 29

yes, but it must:
- In an emergency, emergency quantities of schedule II substances may be dispensed on an oral prescription order of a medical practitioner.
- Must be immediately reduced to writing by the pharmacist and shall contain all the information required for schedule II drugs except for the manual signing of the order by the medical practitioner
- Within 7 days after authorizing an emergency oral prescription order, the prescribing medical practitioner
shall cause a written prescription order manually signed for the emergency quantity prescribed to be
delivered to the dispensing pharmacist
- It shall have written on its face (or indicated electronically), “authorization for emergency dispensing” and the date of the oral order
- IF prescribing medical practitioner fails to deliver such an emergency prescription order within 7 days in conformance with board rules the pharmacist shall notify the board
- Failure to notify the board shall void the authorized conferred by this subsection to dispense without a written, manually signed prescription order of a medical practitioner.
- Required under federal law to notify who? DEA!!

Question 30

when can a prescription be transmitted to a pharmacy by facsimile by a patient’s medical practitioner or the practitioner’s agent and are considered the original prescription for record keeping purposes?
CII

Answer 30

• Prescription order written for schedule II to be compounded for the direct administrative to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion
• A prescription order written for any schedule II for a resident of a LTCF
• A prescription for a schedule II controlled substance for a patient enrolled in hospice care program certified or paid for by Medicare under Title XVIII or a hospice program licensed by the state.
• The practitioner or his/her agent must note on the prescription that the patient is a hospice patient.
• A medical practitioner or medical practitioner’s agent may fax a prescription order for a Schedule II controlled substance for information purposes only
• A pharmacy may receive a fax prescription order for a schedule II controlled substance for information purposes only so for the information section a pharmacist can start counting but an not put a label on it, otherwise it is considered misbranded

Question 31

Prescription orders and refills for CIII, IV.

Answer 31

prescription order required Except when dispensed directly by a medical practitioner to the ultimate user, a controlled substance included in schedule III or IV that requires a prescription order shall not be dispensed without a written or oral prescription order of a medical practitioner

Question 32

Things to keep in mind for prescription orders and refills for CIII, IV

Answer 32

• The prescription order shall not be filled or refilled more than 6 months after the date on which the prescription order was issued
• A prescription order authorized to be refilled shall not be refilled more than 5 times.
• Additional quantities may only be authorized by the prescribing medical practitioner through issuance of a new prescription order that shall be treated by the pharmacist as a new and separate prescription order.

Question 33

Prescription orders and refills- Schedule V

Answer 33

A controlled substance included in schedule V and that requires a prescription order can be dispensed under a written (includes fax) or oral prescription order of a medical practitioner. The prescription order may be refilled as authorized by the prescribing medical practitioner, but shall NOT be filled or refilled more than one year after the date of issuance.

Question 34

A controlled substance listed in schedule III, IV, or V and that does not require a prescription order as determined under state or federal laws may be dispensed at retail by a pharmacist, or pharmacy intern under the pharmacist’s supervision without a prescription order to a purchaser who is at least 18 years (!!!!) of age if

Answer 34

• It is for a legitimate medical purpose
• Not more than 240cc (8oz) of any such controlled substance containing opium, nor more than 120 cc (4 oz) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage
  units of any other controlled substance may be dispensed at retail to the same purchaser in any given 48 hour period
• The pharmacist or intern requires every purchaser of a non-prescription controlled substance who isn’t known to the pharmacist to furnish suitable identification, including proof of age
• A bound record book for dispensing controlled substances under this subsection is maintained by the pharmacist and contains the name and address of the purchaser, the name and quantity of the controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist, or intern who dispensed the substance to the purchaser. Must be kept in conformity with record keeping requirements.

Question 35

The label on a container of a controlled substance that is directly dispensed by a medical practitioner or pharmacist and that is not for the immediate administration to the ultimate user, shall bear the:

Answer 35

(1) name and address of the dispensing medical practitioner or pharmacist,
(2) the serial number,
(3) the date of dispensing,
(4) the name of the prescriber,
(5) the name of the patient or, if an animal, the name of the owner of the animal and the species of the animal,
(6) the directions for use and cautionary statements, if any, contained in the prescription order or required by law

Question 36

Prescription labeling requirements for controlled substances in schedule II, III, IV

Answer 36

If the controlled substance is included in schedule II, III or IV, the label shall bear a transfer warning to the effect: “Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

The container of a schedule II controlled substance that is an opioid that is directly dispensed by a pharmacist and that is not for the immediate administration to the ultimate user shall have a RED CAP and a WARNING label prescribed by the board about potential addiction. The board or the executive director, if delegated by the board, may waive the red cap requirement if implementing the requirement is not feasible because of the specific dosage form or packaging type.

Question 37

What prescription can be transmitted by fax from a medical practitioner to a pharmacy?

Answer 37

schedule III, IV, or V controlled substance, prescription-only drug, or nonprescription drug can be faxed

Question 38

scchedule III, IV, or V controlled substance, prescription-only drug, or nonprescription drug that is faxed must include:

Answer 38

a. The prescription order is faxed only to the pharmacy of the patient’s choice;
b. The faxed prescription order:
i. Contains all the information required for a prescription order
ii. Is only faxed from the medical practitioner’s practice location, except that a nurse in a hospital, long-term care facility, or inpatient hospice may send a facsimile of a prescription order for a patient of the facility; and
c. The faxed prescription order shall contain the following additional information:
i. The date the prescription order is faxed;
ii. The facsimile number of the prescribing medical practitioner or the facility from which the prescription order is faxed, and the telephone number of
the facility; and
iii. The name of the person who transmits the facsimile, if other than the medical practitioner

Question 39

schedule III, IV, or V controlled substance, prescription-only drug, or nonprescription drug that is faxed recording keeping?

Answer 39

7 YEAR RECORD RETENTION AS A PRESCRIPTION RECORD- can store a photocopy of the fax

A medical practitioner or the medical practitioner’s agent may fax refill authorizations to a pharmacy if the
faxed authorization includes the medical practitioner’s telephone number and facsimile number, the medical
practitioner’s signature or medical practitioner’s agent’s name, and date of authorization

Question 40

electronic transmission of a prescription order from a medical practitioner to a pharmacy requirement?

Answer 40

1. A medical practitioner or medical practitioner’s agent may transmit a prescription order by electronic means
2. complies with any security or other requirements of federal law.
3. The medical practitioner and pharmacy shall ensure that all electronic transmissions comply with all the security requirements of state or federal law related to the privacy of protected health information (HIPAA
   compliant).
4. electronically transmitted prescription orders also must include:
   ◦ a. The date of transmission; and
   ◦ b. If the individual transmitting the prescription is not the medical practitioner, the name of the medical practitioner’s authorized agent who transmits the prescription order.
5. Must be retained for 7 years!!!!
6. Must be transmitted only to the pharmacy of the patient’s choice

Question 41

Exceptions to electronic

prescribing requirements

Answer 41

Medical practitioners- may use written prescription:
◦ In this state to be filled in a jurisdiction outside of this state
◦ For a medication that requires compounding two or more ingredients
◦ For a medication not in the e-prescribing database
◦ For individual detained or in custody of Arizona or federal law enforcement agency

Pharmacy exceptions may dispense from written order if the prescription order
◦ Is written by a medical practitioner not licensed in this state, but another state
◦ Is written for medication that requires compounding two or more ingredients
◦ Is written for med not in e-prescribing database
◦ Is written for individual who is detained by or in custody of AZ or federal law enforcement

No e-prescribing for oral emergency CII

Question 42

Arizona transfer requirements

Answer 42

Same as federal

Question 43

Federal tranfer requirements

Answer 43

The transfer of original prescription order information for a Schedule III, IV, or V controlled substance meets the following conditions:
◦ The transfer of information is communicated directly between two licensed pharmacists or interns electronically or verbally;
◦ The following information is recorded by the transferring pharmacist or intern:
◦ The word “void” is written on the face of the invalidated original prescription order unless it is an electronic or oral transfer and the transferred prescription order information is invalidated in the transferring pharmacy’s computer system; and
◦ The name, address, and DEA number of the pharmacy to which the prescription is transferred, the name of the receiving pharmacist, the date of transfer, and the name of the transferring pharmacist is written on the back of the prescription order or entered into the transferring pharmacy’s computer system; and
◦ The following information is recorded by the receiving pharmacist on the transferred prescription order:
◦ The word “transfer;”
◦ Date of issuance of original prescription order;
◦ Original number of refills authorized on the original prescription order;
◦ Date of original dispensing;
◦ Number of valid refills remaining and the date of the last refill;
◦ Name, address, DEA number, and original prescription number of the pharmacy from which the prescription is transferred;
◦ Name of the transferring pharmacist; and
◦ Name of the receiving pharmacist

Original and transferred prescription record is maintained for 7 years!!!! (A.R.S. 32-1964)

Question 44

What are the prescription requirements for receiving a prescription from out of state?

Answer 44

For a transfer from out of state:
1 between to pharmacists or interns
2. The following information is recorded by the receiving pharmacist on the transferred prescription order:
◦ (1) The word “transfer;”
◦ (2) Date of issuance of original prescription order;
◦ (3) Original number of refills authorized on the original prescription order;
◦ (4) Date of original dispensing;
◦ (5) Number of valid refills remaining and the date of the last refill;
◦ (6) Name, address, DEA number, and original prescription number of the pharmacy from which the prescription is
transferred;
◦ (7) Name of the transferring pharmacist; and
◦ (8) Name of the receiving pharmacist;

Question 45

What requirements must an electronic transfer prescription meet?

Answer 45

• The electronic transfer is between pharmacies owned by the same company using a common or shared database
• The electronic transfer of original prescription order information for a controlled substance is performed between two licensed PHARMACISTS!!!
   The electronic transfer of original prescription order information for a controlled substance meets the following conditions:
   The transferring pharmacy’s computer system:
  - Invalidates the transferred original prescription order information
  - Records the identification code, number, or addresses and DEA number of the pharmacy to which the prescription order information is transferred
  - Records the name or identification code of the receiving pharmacist
  - Records the date of transfer
  - Records the name or identification code of the transferring pharmacist.
   The electronic prescription order received by the computer system of the receiving pharmacy includes the information required for a transferred CS prescription AND
   In addition to electronic documentation of a transferred prescription order in the computer system, an original prescription order containing the requirements of this section is filed in compliance with A.R.S. 32-1964. (Record storage- original prescriptions, serial numbers)

Question 46

prescription record keeping

Answer 46

a person registered to dispense must keep and maintain prescription orders
 Schedules I and II must be maintained in a separate prescription file for controlled substances listed in schedules I and II only
 Schedules III, IV, and V must be maintained either in a separate prescription file OR in a form that allows them to be readily retrievable from the other prescription records of the registrant. (the C stamp on them) same as federal

Question 47

What do you do with the prescription records of drugs, devices or replacement soft contact lenses that are compounded or
dispensed at the pharmacy,

Answer 47

◦ serially numbered, dated and filed in the order in which the drugs, devices or replacement soft contact lenses were
compounded or dispensed.
◦ A prescription order shall be kept for at least seven years!!!

Weird rules:
prescription original hard-copy prescription is maintained for ne less than 30 days after the date dispensed.

Question 48

Can you transfer an unfilled prescription?

Answer 48

NO

Question 49

What is unlawful?

Answer 49

 Intentionally or knowingly distribute or dispense a controlled substance in violation of 36-2525.
 Intentionally or knowingly manufacture a controlled substance not authorized by that person’s registration or to intentionally or knowingly
distribute or dispense a controlled substance not authorized by that person’s registration to another registrant or authorized person.
 Intentionally or knowingly refuse or fail to make, keep, or furnish any record, notification, order form, statement, invoice, or information
required under this chapter
 Intentionally or knowingly refuse an entry into any premise for any inspection authorized by this chapter
 Knowingly dispense or deliver anabolic steroids without a written prescription for a nontherapeutic use
 To intentionally or knowingly sell, buy, exchange, or give away any prescription subject to 36-2516, unless the prescription is to be used for
a legitimate medical purpose and in compliance with this chapter.
 Distribute as a registrant a controlled substance classified in schedule I or II, except pursuant to an order form as required by 36-2524
 To furnish false or fraudulent material information in, or omit any material information from, any application, report, or other document
required to be kept or filled under this chapter or any record required to be kept by this chapter

Question 50

Administrative Inspections and

Warrants

Answer 50

Judge within its jurisdiction can issue warrants
Warrants shall:
 State the grounds for its issuance and the name of each person whose affidavit has been taken in support thereof
 Be directed to a peace officer to execute it
 Command the person to whom it is directed to inspect the area, premises, building or conveyance identified for the purpose specified and if appropriate direct the
seizure of the property specified
 Identify the item or type of property to be seized, if any
 Direct that it be served during normal business hours and designate the judge or magistrate to whom it shall be returned

Must be executed and returned within 10 days of its date, unless, upon a showing of a need for additional time

Question 51

Pursuant to a warrant: officer or employee may

Answer 51

 Inspect and copy records required by Az CSA to be kept
 Inventory any stock of any controlled substance and obtain samples of such substance
 Inspect within reasonable limits and in a reasonable manner, controlled premises and all pertinent equipment , finished and unfinished
material, containers and labeling found in such premises, and except
-Financial data, sales data, other than shipment data or pricing data, unless the owner, operator, or agent in charge of the controlled premises consents in writing

Question 52

Without a warrant officer or employee may enter and administratively inspect, including seizing property and inspect books and records pursuant to an administrative subpoena without a warrant IF

Answer 52

 Owner, operator, or agent in charge of the controlled premises consents
 The situation presents imminent danger to health or safety
 If there is reasonable cause to believe that the mobility of the conveyance makes it impractical to obtain a warrant
 In any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking
 In all other situations in which a warrant is not constitutionally required.

Question 53

You are discontinue operation, when should the notice be provided to the board and DEA

Answer 53

A pharmacy permittee or PIC shall provide written notice to the Board and the DEA at least 14 days before discontinuing operation of the pharmacy. Notice shall contain
the following

Question 54

(closing business example) The discontinuation of operation notice should include:

Answer 54

◦ 1. Name, address, pharmacy permit number, and D.E.A. registration number of the pharmacy discontinuing business;
◦ 2. Name, address, pharmacy permit number (if applicable), and D.E.A. registration number (if applicable) of the licensee, permittee, or registrant to whom any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical will be sold or transferred;
◦ 3. Name and address of the location where the discontinuing pharmacy’s records of purchase and disbursement of any narcotic or other controlled substance, prescription-only drug or
device, nonprescription drug, precursor chemical, or regulated chemical will be kept and the person responsible for the records. These records shall be kept for a minimum of three years from the date the pharmacy is discontinued;
◦ 4. Name and address of the location where the discontinuing pharmacy’s prescription files and patient profiles will be kept and the person responsible for the files and profiles. These records shall be kept for a minimum of seven years from the date the last original or refill prescription was dispensed; and
◦ 5. The proposed date of discontinuing business operations.

Question 55

Form 222 when closing pharmacy

Answer 55

Pharmacy permittee or PIC shall ensure that all DEA registration certificates and DEA schedule II order forms (Form 222) are returned to the DEA Regional Office in Phoenix

Question 56

PIC of the pharmacy should when discounting operations

Answer 56

 Only a pharmacist has access to the prescription only drugs and controlled substances until they are transferred to the licensee, permittee, or registrant listed in A(2)
 All narcotics or other controlled substances, prescription only drugs or devices, nonprescription drugs precursor chemicals or regulated chemicals are removed from the premises on or
before the date the pharmacy is discontinued. And
 All controlled substances are transferred as follows:
 Take an inventory of all controlled substances that are transferred using the procedures in R4-23-1003 [Inventory describe above]
 Include a copy of the inventory with the controlled substances that are transferred
 Keep the original of the inventory with the discontinued pharmacy’s records of narcotic or other controlled substance, prescription only drug or device, nonprescription drug, precursor chemical or regulated chemical purchase and
disbursement for a minimum of three years from the date the pharmacy is discontinued.
 Use a DEA Form 222 to transfer any schedule II controlled substances
 Transfer controlled substances that need destruction in the same manner as all other controlled substance

Question 57

Discontinuing Pharmacy:

Controlled Substance requirements

Answer 57

Upon receipt of outdated or damaged controlled substances from a discontinued pharmacy, THE RECEIVING
Pharmacy shall contact a D.E.A. registered reverse distributor for proper destruction of outdated or damaged
controlled substances. If there are controlled substances a reverse distributor will not accept, the licensee,
permittee, or registrant shall then contact the Board office and request an inspection for the purpose of drug
destruction.

During the three-year record retention period specified in subsection (A)(3), the person described in subsection
(A)(3) shall provide to the Board upon its request a discontinued pharmacy’s records of the purchase and
disbursement of narcotics or other controlled substances, prescription-only drugs or devices, nonprescription
drugs, precursor chemicals, or regulated chemicals.

Question 58

LTCF

Answer 58

Automated dispensing systems

Obtain separate controlled substance registration at the location of each LTCF where automated
dispensing system containing CS will be located

Controlled substance drugs contained in automated dispensing system remain the property of
the pharmacy- and CS drugs are included in inventories

CII drugs are not stocked in an automated dispensing system

Question 59

LTCF - Emergency Drugs

Emergency drug supply UNIT-

Answer 59

The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that:
◦ An emergency drug supply unit is available within the long-term care facility,
◦ Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy, and
◦ Controlled substance drugs contained in an emergency drug supply unit are included in all inventories

Drug removal procedures that require:
o The long-term care facility’s personnel receive a valid prescription order for each
o drug removed from the emergency drug supply unit,
o The long-term care facility’s personnel notify the provider pharmacy when a drug is removed from the emergency drug supply unit,
o Outdated drug replacement procedures, and
o Security and inspection procedures

Question 60

Key facts involving automated and emergency unit

Answer 60

The pharmacy permittee or pharmacist-in-charge of the provider pharmacy notifies the Board in writing of the intent to use an automated
emergency drug supply unit, including the name and type of unit;

The provider pharmacy is notified electronically when the automated emergency drug supply unit has been accessed;

All events involving the access of the automated emergency drug supply unit are recorded electronically and maintained for not less than two
years;

The provider pharmacy is capable of producing a report of all transactions of the automated emergency drug supply unit including a single drug
usage report as required on inspection by the Board or its staff