Pharmacy Law Exam 3- Part I

Front 1

In the DEA’s Pharmacist Manual, read section 14 “Summary of the Act’s Major Provisions”. Name three chemicals that are controlled by these requirements. (List 1 chemical drug products)

Back 1

ephedrine, pseudoephedrine, and phenylpropanolamine (PPA)

Front 2

Why are these chemicals (list 1) controlled and why was the law passed?

Back 2

can be used to manufacture methamphetamine illegally

Front 3

In the DEA’s Pharmacist Manual, read section 14. What is the official name of the federal law that restricts sales of these chemicals (list 1)?

Back 3

Combat Methamphetamine Epidemic Act of 2005 (CMEA).

Front 4

Retail sellers that handle products containing List 1 chemicals must however comply with the other requirements of the CMEA. There are seven (7).

3 are regarding limits
1 is regarding where to put shit
2 regarding monitoring/logs
1 training

Back 4

1) products must be behind the counter or in locked cabinets
2) check ID of purchasers and maintain log of sales (must include name/address/signature, product sold, qt sold, date and time)
3) log book must be maintained for 2 years
4) must train employees in law requirements and certify to DEA that training has occured
5) places qt limit of 3.6g per day regardless of # of transactions
6) for nonliquids, packaging limited to blister packs containing no more than 2 dosage units per blister. Or if not available, use unit dose packets.
7) 30 day limit = 9 grams of which no more than 7.5 grams can be imported by a means of common/contract carrier or the USPS? wtf. oh. mail order limit is 7.5 g.

Front 5

Read the “Summary of Act’s Major Provisions”. Under the CMEA pharmacies generally fit the category of retail distributor, meaning that the sales of List 1 chemical drug products are for “at retail”. How does the CMEA define at retail?

Back 5

CMEA defined "at retail" to mean sale or purchase for personal use.

Front 6

What is the “daily quantity set for sale of pseudoephedrine?

Back 6

3.6 g

Front 7

What is the “daily quantity set for sale of phenylpropanolamine (PPA)?

Back 7

3.6g

Front 8

What is the “monthly quantity set for sale of drug products containing some amount of ephedrine HCl?

Back 8

9 grams, of which not more than 7.5 grams may be imported by means of a common or contract carrier or the U.S. Postal Service.

Front 9

There are “other requirements” for pharmacies listed in “Summary of the Act’s Major
Provisions.” The “other requirements” lists seven: What are the seven? wtf isn't this the same question

Back 9

• Place the products behind the counter or in locked cabinets
• Check the ID of purchasers and maintain a log of each sale that includes the
purchaser’s name/address, signature, product sold, quantity sold, date, time
• Maintain logbook for at least 2 years
• Train employees in the requirements of the law and certify to DEA that the training
has occurred
• Quantity limit of 3.6 grams per day of the chemical base without regard to # of
transactions
• For nonliquids, product packaging is limited to blister packs containing no more than
2 dosage units per blister. When blister packs are not feasible, product must be
packaged in unit dose packets or pouches
• Quantity limit of 9 grams per 30 days, of which not more than 7.5 grams may be
imported by means of a common or contract carrier or the U.S. Postal Service

Front 10

You are requested to study Appendix G of the Pharmacist’s Manual. Appendix G translates the CMEA’s weight requirements in grams into the number of tablets of each of the two main List 1 chemical drug products that would meet the limit requirement. Read the two charts. How many tablets of a product containing 25mg of ephedrine HCl would it take to meet the daily and monthly limits allowed

Back 10

175 tabs for daily

439 tabs for monthly (366 for mail order)

Front 11

How many tablets of a single-entity product containing 30mg of pseudoephedrine HCl would it take to meet the daily and monthly quantity limits under the CMEA requirements

Back 11

146 for daily

366 = 9 g

305 = 7.5 g

Front 12

Considering the act, pharmacies, and other retailers, that sell these List 1 chemical drug products must keep a logbook of transactions. What are the four requirements for each sale to be recorded?

Back 12

1. The name of the purchaser
2. The address of the purchaser
3. The date and time of the sale
4. The amount/product sold

Front 13

If a customer purchases a single box of 24 tablets of pseudoephedrine HCl 30 mg. for legitimate medical use, is the retail pharmacy required to meet the record-keeping requirement of CMEA for that sale? Why or why not?

Back 13

Yes, because it contains more than 60 milligrams of pseudoephedrine. The logbook
requirement only does not apply to any purchase of a single sales package that
contains not more than 60 milligrams of pseudoephedrine.

Front 14

What is the seller required to do with the purchaser’s identification? (2)

Back 14

1. Determine that the name in the logbook corresponds to the name on the identification and that the date and time are correct.
2. Enter into the logbook the name of the product and the quantity sold

Front 15

Go back to the Table of Contents of the Pharmacists Manual. You will now study Controlled Substances. What is a schedule I substance? (3 properties)

Back 15

Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision

Front 16

Give three examples of Schedule I substances (6 total)

Back 16

heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (“ecstasy”).

Front 17

What are Schedule II Substances (definition)?

Back 17

Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence

Front 18

Give three examples of Schedule II Substances

Back 18

narcs: opium/morphine
stimulants (amphetamine salts)

cocaine, amobarbital, glutethimide, and pentobarbital

Front 19

What are Schedule III Substances (definition)?

Back 19

Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence

Front 20

Give three examples of Schedule III Substances (8 total?)

Back 20

combination products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin®) and products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine®). Also included are buprenorphine products (Suboxone® and Subutex®) used to treat opioid addiction

Examples of schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).

Front 21

What are Schedule IV Substances (definition)?

Back 21

Substances in this schedule have a low potential for abuse relative to substances in schedule III.

Front 22

Give three examples of Schedule IV Substances. (2 broad categories)

Back 22

An example of a schedule IV narcotic is propoxyphene (Darvon® and Darvocet-N 100®).
Other schedule IV substances include the benzos


e.g. alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).

Front 23

What are Schedule V Substances (definition)?

generally used for what 3 purposes

Back 23

Substances in this schedule have a low potential for abuse relative to substances listed in schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes.

Front 24

Give three examples of Schedule V Substances. [Note: The Pharmacists Manual lists two, therefore you have to find another way to list one more].

Back 24

Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®).

diphenoxylate (opioid agonist for diarrhea) /atropine (Lomotil®)

Front 25

The federal government requires that any pharmacy that ___________________ _______________ must register with the DEA. Fill in the blank with the omitted phrase.

Back 25

that dispenses a controlled substance

Front 26

How often must the federal (DEA?) registration be renewed? using wat form?

Back 26

A pharmacy registration must be renewed every three years utilizing DEA Form 224a

Front 27

If you own three pharmacies, all under one corporation, how many registrations must you apply for? (and form)

Back 27

Corporations that own or operate a chain of pharmacies may submit a single DEA Form 224b


if a person owns and operates more than one pharmacy, each place of business must be registered.???? WHAT.

Front 28

Go back to the Table of Contents to “Denial, Revocation or Suspension of Registration” under Registration Requirements.

If a pharmacist has been convicted of possession of marijuana as a felony, may he or she have the DEA registration of his or her pharmacy suspended or revoked? Why or why not?

Back 28

Yes, because the pharmacist has been convicted of a felony relating to a controlled
substance or List 1 chemical

Front 29

If the state of Iowa suspends the license of a pharmacy may the DEA registration be suspended or revoked without more proof? Why or why not?

Back 29

Yes, that is one of the conditions on revoking DEA under CSA 21 USC...thing

Had a State license or registration suspended, revoked, or denied by a competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or List I chemicals or has had the suspension, revocation, or denial of a registration recommended by competent State authority;

Front 30

if the DEA learns that a pharmacy’s application contains answers that are false and the answer is material to the purpose of the registration, may the DEA suspend or revoke the pharmacy’s registration years later?

Back 30

yes, this is a condition of revocation under CSA 21 USC thing.

Has materially falsified the application

Front 31

Name three steps a pharmacy registrant must do if it sells the pharmacy or closes and discontinues the business or transfers it to another person. [Hint: there are 5]

Back 31

1. Submit (to special agent in charge) name/address/registration number/authorized business activity of
registrant (transferor) and person acquiring business (transferee); whether
business will continue at current location or at a new location; date of
transfer of controlled substances
2. Take a complete inventory and include a copy of the inventory in records of
both the transferor and transferee on the day controlled substances are transferred
3. The transferee must issue an official order form (DEA Form 222) or electronic equivalent to the transferor to transfer schedule II controlled substances
4. All controlled substance records required to be kept by the registrant-transferor shall be transferred to the registrant-transferee
5. DEA registration application: If the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy being transferred, the registrant may apply for a new DEA registration prior to the date of transfer

Front 32

If a pharmacy sells and transfers the business to another registrant, when must she/he notify the DEA Registration Field Office of the transfer and provide the required information?

Back 32

at least 14 days in advance of the date of the proposed transfer (unless waived)

Front 33

You have decided to sell your pharmacy to an existing small pharmacy chain operation in your area of the state. What, regarding the transfer of controlled substances, must you do on the day the controlled substances are transferred?

Back 33

a complete inventory must be taken and a copy of the inventory must be included in the records of both the person transferring the business and the person acquiring the business.

Front 34

If you are the general manager of the small chain acquiring an existing pharmacy that will be transferring its controlled substances to you, when can you first apply for a new DEA registration? [Hint: prior to, on the day of, or within a certain number of days after the transfer.]

Back 34

prior to the date of transfer

Front 35

Go to “Disposal of Controlled Substances”. May a pharmacy may hire an outside firm to inventory and package its controlled substances for a transfer to another pharmacy, supplier or manufacturer? If so, is the pharmacy relieved of its responsibility for the accuracy of the inventory and records? [Hint: there are two questions thus two answers are required. It may be “yes / yes” or “no / yes” or any combination, but the answers must be in the correct order.

Back 35

yes/no

Front 36

A pharmacy may also transfer drugs to an outside distributor (reverse distributor) for the purpose of destroying controlled substances. Prior to turning the controlled substances over to a reverse distributor, however, the pharmacy must do what? (different for schedule II vs. III-V)

Back 36

must get prior approval from DEA???

no.

Document the transfer of controlled substances (DEA Form 222 issued by reverse distributer for schedule II and record
of distribution containing drug name, dosage form, strength, quantity, and date transferred
for schedule III-V)

Front 37

You have sold your pharmacy and are transferring some Schedule II substances to the purchaser. What form must be prepared to document the transfer of the Schedule II drugs? [there are only two or three form numbers you should know – this is one]

Back 37

DEA Form 222

Front 38

If a pharmacy hires an outside reverse distributor to destroy controlled substances, how long must the records involving the transfer or destruction be kept and available for inspection and copying by the DEA?

Back 38

2 years

Front 39

When a pharmacy is sold and the controlled substances are transferred a complete inventory must be taken. This inventory serves three purposes. What are they? [Hint: Read the Pharmacist Manual sections entitled: “Transfer of Controlled Substances” and “To Another Pharmacy” to answer this question. One part of the answer is found in the first and the other two parts are found in the second.] (3)

Back 39

1) for inspection by the DEA (to serve as bienniel inventory)
2) to serve as the final inventory for the registrant going out of business and transferring the controlled substances.
3) It will also serve as the initial inventory for the registrant acquiring the controlled substances.

Front 40

See “Destruction of Controlled Substances”. Prior to disposing of any controlled substances, the DEA recommends that a pharmacy first seek disposal instructions by contacting whom?

Back 40

local DEA Diversion Field Office

Front 41

According to the Pharmacists Manual, how often may a retail pharmacy request DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances?

Back 41

once per year?

Front 42

When destroying the controlled substances, who must complete the required form (DEA Form-41: Registrants Inventory of Drugs Surrendered ) for the DEA.

Back 42

DEA registered reverse distributor who will destroy the controlled substances

Front 43

The witnesses to the destruction are required to meet certain qualifications. What qualifications must the witnesses meet? Are these Federal or State requirements (3)

Back 43

pharmacy/pharmacy tech

board officer

The witness must be a responsible adult with no violations or sanctions against
them within the last five (5) years. This is a state requirement

Front 44

The required form (DEA form 41) must be received by the DEA when?

Back 44

when the controlled substances have been destroyed.

Front 45

Read the “Security Requirements” section of the Pharmacists Manual Appendix A. To deter theft, the DEA requires CS (Schedules II through V) to be secured and give two alternative ways a pharmacy may keep the CS in its inventory. What are these two ways?

Back 45

Locked cabinet or dispersed among non-controlled pharmaceuticals

Front 46

Very seldom does the federal government tell you who you cannot employ. The DEA does in certain circumstances. Under what circumstances does the DEA say you may not employ someone in your pharmacy? [see “Request for Employment Waiver for Certain Pharmacy Employees”] The DEA Pharmacists Manual says you must not employ anyone who: (2)

Back 46

any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause.

Front 47

You may request a waiver if you desire to employ an individual who meets the above requirements (druggies).

When does the waiver have to be approved in relation to when you hire the individual?

Back 47

before allowing such an employee or prospective employee to have access to controlled substances.

Front 48

Immediately upon discovery of a theft or significant loss of CS, a pharmacy is required to contact who? Within what time frame?

Back 48

Notify DEA and local police

within one business day of the discovery of the theft or loss.

Front 49

A pharmacy must complete a DEA form entitled “Report of Theft or Loss of Controlled Substances”. This is another of those form numbers a pharmacist should know. What is the form number used to report a theft or loss of CS?

Back 49

DEA Form 106

Front 50

A pharmacy is required to report not only a theft of CS, but also a “significant loss”. How do the DEA and the Controlled Substance regulations define “significant loss” in the Pharmacists Manual?

Back 50

They do not specifically define it, but rather state that it is the responsibility of the registrant
to use their best judgment to take appropriate action. A “significant loss” depends in part on the business of the pharmacy and the likelihood of a rational explanation for a particular
occurrence.

Front 51

What federal law, passed in 1984, makes most pharmaceutical thefts and robberies of a pharmacy a federal crime and provides for federal investigation, usually by the FBI?

Back 51

The Controlled Substance Registrant Protection Act of 1984 (CSRPA)

Front 52

6 factors to consider in deciding whether a loss is significant

Back 52

1. The actual quantity of controlled substances lost in relation to the type of business;
2. The specific controlled substances;
3. Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4. A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known
5. Whether the specific controlled substances are likely candidates for diversion; and
6. Local trends and other indicators of the diversion potential of the missing controlled substances.

Front 53

What are the conditions that make a drug store robbery to be a federal crime and under the jurisdiction of the FBI? [Hint: there are three and any of the three make it a federal crime.]

Back 53

1. The replacement cost of the controlled substances taken is $500 or more
2. Interstate or foreign commerce was involved in the execution of the crime
3. A person was killed or suffered significant bodily injury as a result of the crime

Front 54

Read “Recordkeeping Requirements” section of the Pharmacists Manual. Fill in the blank in the following sentence. “Every pharmacy must maintain complete and accurate records on a ________________ basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposed of.”

Back 54

current

Front 55

How long must the records relating to CS be maintained?

Back 55

2 years

Front 56

Which records and inventories must be kept separately from all other records and inventories of the pharmacy?

Back 56

Records and inventories of schedule II controlled substances must be maintained separately from all other records of the registrant.

Front 57

Which CS (controlled substance) records must be maintained?

Back 57

Records and inventories of schedules II, III, IV, and V controlled substances must be
maintained

Front 58

Under the Code of Federal Regulations, pharmacies have three options for filing prescription records. Describe the three options.

Back 58

1. A file for schedule II controlled substances dispensed; a file for schedules III, IV, and V
controlled substances dispensed; a file for all noncontrolled substances dispensed (3
separate files)
2. A file for all schedule II controlled substances dispensed; a file for all other drugs
dispensed, where schedule III, IV, and V controlled substance prescriptions must be
readily retrievable by use of a red “C” stamp ≥ 1” high (2 separate files)
3. Electronic prescription records, in which records regarding controlled substances must
be readily retrievable from all other records

Front 59

In two of the above options (for filing) a special mark must be placed on each Schedule III, IV and V prescription. Describe that special mark.

Back 59

red "C" stamp not less than one inch high if if filed with other rx

Front 60

How often and when must the biennial inventory be taken?

Back 60

Every two years following initial inventory on any date which is within two years of the
previous inventory date

Front 61

Your employer asked you to order three Schedule II drugs. What DEA form do you use to order them

Back 61

DEA Form 222

Front 62

The DEA Official Order Form for Schedule II CS comes in a book. How many sets of forms are in each book?

Back 62

7 sets of forms

Front 63

Who may sign the DEA Official Order Form (CII) (2)

Back 63

A person authorized to sign a registration application or a person granted power of attorney

Front 64

What is the pharmacist’s duty when the Schedule II drugs that were ordered from the
wholesaler arrive?

Back 64

The pharmacist must document on the purchaser’s copy (copy three) the actual number of
packages received and the date received

Front 65

You are filling out the Official Order Form to purchase the Schedule II drugs as your employer requested. After completing the form you are told that the pharmacy only needs one bottle of the item you had ordered in a quantity of three. May you mark out or erase the “3” and place a “1” in that spot?

Back 65

no

Front 66

Your employer says she/he wants you to be able to order and execute the Official Order Forms.

What does your employer (or the person who signed the most recent application for registration or renewal) have to do to give you that authority and what must you do?

Back 66

The employer must grant power of attorney (what is this) to me and both of us have to sign the power of
attorney form.

Front 67

Where do you file the form giving you authority to order and execute the Official Order Forms?

Back 67

It should be filed with executed DEA Forms 222 as a readily retrievable record

Front 68

After a few days you are informed that the Schedule II drugs you ordered have not been received. What must you (or the pharmacy) do? (5)

Back 68

We must first contact the supplier to determine whether the original DEA Form 222
was received.

If it has been lost or stolen, we must complete a second order form so the supplier can fill the original order.

We must also prepare a statement which includes
the first order form’s serial number/date, and verify the drugs were never received.

A
copy of the statement must be attached to the second order form that is sent to the
supplier.

The pharmacist must keep a copy of the statement with copy three from the
first and second order forms.

Front 69

You notice that one of the unused Official Order Forms is missing. What are you required to do under federal CS laws?

Back 69

Immediately report the loss to the local DEA Diversion Field Office and provide the serial
numbers of each lost/stolen order form

Front 70

What records must your pharmacy keep regarding the ordering of Schedule III through V CS? what must be on it (4)?

Back 70

A receipt (invoice or packing slip) which records the date the drugs were received and
confirm the order is accurate. The receipt must also contain the name of each controlled
substance, the finished form, the number of dosage units in each container, and the
number of containers ordered and received

Front 71

Read “Prescription Requirements” for controlled substance prescriptions. What is a "prescription" under the federal controlled substance regulations? What is it NOT?

Back 71

An order for medication which is dispensed to or for an ultimate user (NOT an
order for medication which is dispensed for immediate administration to the
ultimate user)