Pharm Law exam 3 lecture 3

Question 1

Update to the last lecture, what are the registration tyes that do not permit coincidental acitivity

Answer 1

Reverse distributing and exporting

Question 2

Pharmacies/ anyone with dispensing or instructing registration may perform the following coincidental activities

Answer 2

May conduct research and instructional activities with substances for which registration was granted

A pharmacist may manufacture product containing a narcotic controlled substance in schedule II-V in a proportion not exceeding 20% of the complete solution, compound or mixture
A retain pharmacy may perform central fill activities

Question 3

When can a pharmacy distribute a controlled substance to another practitioner

Answer 3

So long as the distribution does not exceed 5% of the total dosage united distributed within the same year

Question 4

What does the controlled substance act state

Answer 4

Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.

Question 5

according to CSA, after registrants put safety measures in place, and the DEA determines whether they are appropriate. The DEA considers

Answer 5

-Activities conducted
-Type and form of CS handled
- Quantity of CS handled
- Storage system of CS

Question 6

What does the CSA state about employee screening

Answer 6

The registrant shall not employ 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.

Question 7

DEA recommended questions for employee screening

Answer 7

• within the past 5 yrs, have you been convicted of a felony or within last 2 yrs any misdemeanor or are you presently formally charged with commiting a criminal offense.

In past 3 yrs, have you ever knowingly used any narcotics amphetamines or barbiturates, other than those prescribed to you by a physician?

Answers do not disqualify applicants, but should be considered

Question 8

are barbiturates narcotics?

Answer 8

No

Question 9

If a registrant wants to employ an individual who does not qualify for employment what can they do

Answer 9

Apply for a waiver.
The DEA will not consider a waiver unless diversion is unlikely to occur

Question 10

What does the CSA require with regard to records and reports

Answer 10

The CSA requires all records and reports involving CS to be kept for at least 2 years from their origin dat

Question 11

With regard to record keeping, how does the DEA enforce it

Answer 11

10,000 fine for each unintentional violation and more severe penalties or jail time for intentionalviolations

Question 12

What must registrants maintain a complete report of for records and reports regarding CS

Answer 12

Registrants must maintain a complete and accurate reocrd of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them

Question 13

How should C II substances be stored? How should CIII, IV, and V records be kept?

Answer 13

C II records must be kept separately from other records, while C III, C IV and C V records may be kept separately or with other records so long as they are readily retreivable

Question 14

What are the two most common prescription storage systems? Describe them?

Answer 14

Three file system (most common)- File for C II prescription. File for CIII, IV and V prescriptions. File for non controlled prescriptions

Two file system- File for C II prescriptions
File for C III, IV and V and non controlled prescription. ( CIII, IV and V must be readily retreivable)

Question 15

For a prescription to be readily available, what are the criteria it must meet?

Answer 15

Have a red C no less than 1 inch stamped in the lower right corner of the prescriptions face

Must identify prescription number in a computer system and be able to search by
a. prescriber name
b. Patient name
c. Drug dispensed
d. Date filled

Question 16

When does the DEA allow central record keeping

Answer 16

If the registrant notiifes the DEA of its intent in writing 14 days in advance.

If allowed, all records must be transferred to central location within 2 business days

Question 17

Things that can never be stored centrally

Answer 17

Executed order forms
Inventories
Prescriptions

Question 18

How are C III, C IV and C V substances ordered

Answer 18

Ordered the same way as non controlled medications. Can utilize standard invoice of record of receipt so long as it contains

Date
Must be easily identify controlled substance from non controlled medications

Question 19

How to order C IIs (what form? Qhat does it include)

Answer 19

All distributions of C IIs must be completed using DEA form 222
-Includes purchases, transfers and sales
- The only other way to deliver C IIs is via prescription

Question 20

When was the single sheet order form for C IIs introduced?

Answer 20

2019, only form available since oct 2021

Question 21

What is the power of attorney

Answer 21

Only the signatory of the DEA registration may fill out order forms, but agency may be provided to others to execute DEA form 222s through a power of attorney (POA)

Question 22

What are rules for POA that we must know for exam

Answer 22

-A separate POA must be filled out for each person individually
-POAs may be revoked at any time and must be available for inspections alongside other records
- POA agents should sign “roberta registrant by agnes agent, attorney in fact”

Question 23

How to order DEA form 222

Answer 23

order DEA form 222a

Question 24

when submitting a DEA form 222a, what must the form include

Answer 24

Requisitions must have the name, address and registration number of the registrant, and the number of books desired.

Must be signed by the registrant or an authorized agent/

Question 25

Can DEA form 222s be altered?

Answer 25

No

Question 26

What does the current DEA form 222 have?

Answer 26

Supplier information Purchaser name Purchaser signature Date Number of packages Package size Drug name Last line completed

Question 27

purchaser DEA 222 form important points

Answer 27

Forms must be completed via typewriter, computer printer, pen or indelible pencil A filled out form is an executed DEA 222, a blank form is an unexecuted DEA 222 NDCs may be filled in by purchasers, but if the NDC is not available the order may be delayed If you are ordering more than 20 products, you must complete multiple forms ONCE COMPLETED, A COPY OF THE FORM MUST BE MADE BECAUSE THE ORGINAL WILL BE SENT TO THE SUPPLIER If an error occurs when filling out the DEA 222, it must be voided by writing VOID across the front and filed with all other executed forms

Question 28

What information does the supplier fill out on the DEA form 222

Answer 28

Supplier DEA number NDC number for products sent Number of bottles of containers sent date sent

Question 29

What does the supplier do to the original DEA 222?

Answer 29

SUpplier keeps the original DEA 222 and forwards a copy of the form to the DEA by the end of the month, or reports information on the automation of reports and consolidated orders system (ARCOS)

Question 30

unique situations to know about supplier DEA 222? Describe them

Answer 30

Partial filling order Endorsing an order Defective order Order refusal Voiding part of an order Partial filling order- a supplier may partially fill an order, after which time they have 60 days to supply the balance of the order Endorsing an order- a supplier may send an order to another supplier within 60 days. Second supplier fills full order (all or nothing) Defective order- if a supplier finds an issue with a DEA 222, they must send the form back to the purchaser with a statement expplaining refusal to fill Order refusal- a supplier may refuse to accept an order. They must send the form back to the purchaser with a note that the order was not accepted Voiding part of an order- if a supplier cannot fill a full order, they may draw a line through the voided itens and print :canceled: on the number of items shipped.

Question 31

When thepurchaser receives the order, they must record

Answer 31

Date the order is received Number of containers of each item received

Question 32

What happens if executed DEA 222 is lost in mail

Answer 32

Purchaser must execute a new DEA 222 identical to the 1st. A note accompanying this states the original form number, date lost form and note that substances were not received

Question 33

What should happen to unexecuted DEA 222 forms either lost or stolen

Answer 33

Must report to DEA with form numbers if known or dates the forms were ordered if unknown.

Question 34

For unused DEA 222 forms, what should happen if a business is terminated

Answer 34

return forms to DEA

Question 35

What is a digital certificate from the DEA used for

Answer 35

Authorizes a digital certificate as proof of identity The digital certificate gives access to the controlled substance order system (CSOS) which includes drugs from any schedule and non controlled drugs

Question 36

Describe the law on record of CS? When should a drug be inventoried

Answer 36

Every registrant must have a complete and accurate record of all controlled substances on hand on the date the inventory is taken If the drug is in the registrants posession, it must be inventoried

Question 37

What are inventory dates that must occur at pre determined points

Answer 37

1. initial inventory- must be conducted on the day the registrant first engages in activities with controlled substances 2. Official inventory- must be conducted at least once every 2 years (Biennially). SOme states have stricter requirements, CSA states 2 years 3. Rescheduling inventory: Must be conducted when a previously non controlled medication becomes a controlled substance. Only includes the newly controlled drug 4. Final inventory- Conducted when a registrant goes out of business

Question 38

What are the two ways of methods of inventory

Answer 38

At the opening of business on the inventory date At the close of business on on inventory date

Question 39

counting/estimating inventory for CS

Answer 39

C I and C II substances must be inventoried as an exact count CIII, V IV, C V substances may be estimated, unless the bottle holds more than 1000 product units.

Question 40

Can we use a perpetual inventory for offivial inventory for CS?

Answer 40

no, must cpunt, look at and feel weight of product