Pa Mpje/federal Pharmacy Law

Front 1

Schedule I Drugs

Back 1

Methaqualone
Heroin
Mescaline
GHB
LSD
Marijuana
Peyote

Front 2

Schedule II Drugs

Back 2

Amobarbital, Cocaine, Fentanyl, Meperidine, Methamphetamine, Morphine, Oxycodone, Pentobarbital, Amphetamines, Diphenoxylate, Hydromorphone, Methadone, Methylphenidate, MS Contin, Oxycontin, Secobarbital

Front 3

Schedule III Drugs

Back 3

Anabolic Steroids, Buprenorphine, Fiorinal/Codeine, Hydrocodone, Paregoric, Tylenol/Codeine, Xyrem (GHB) sodium oxybate [must have narcolepsy indication on RX], Codeine/ASA, Buprenorphine/Naloxone, Hycodan, Hydrocodone/Ibuprofen, Tussionex, Amobarbital, Secobarbital, Pentobarbital Suppositories, Dronabinol

Front 4

Schedule IV Drugs

Back 4

Alprazolam, Choral Hydrate, Clonazepam, Diazepam, Flurazepam, Oxazepam, Phenobarbital, Sibutramine, Zolpidem, Midazolam, Butorphanol, Chlordiazepoxide, Clorazepate, Ethchlorvynol, Lorazepam, Pentazocine, Propoxyphene Naplsylate/APAP, Temazepam, Halazepam, Mazindol, Triazolam

Front 5

Schedule V Drugs

Back 5

Actifed/Codeine, Novahistine Expectorant, Phenergan/Codeine, Robitussin AC, Tussi-Organidin NR, Lomotil, Novahistine DH, Phergan VC/Codeine, Tylenol/Codeine Liquid

Front 6

Anabolic Steroids

Back 6

Ethylesternol, Stanozolol, Testosterone Patch, Nandrolone decanoate, Fluoxymesterone

Front 7

Under Federal Law, what are the time frames regarding emergency dispensing.

Back 7

Within 7 days, the physician must have delivered (or postmarked) a prescription to the pharmacy with the words "Authorization for emergency dispensing".

In PA, the time frame is 72 hours.

Pharmacist should notify DEA if prescription is not obtained.

Front 8

What are the exceptions to the 72 hour rule for partial filling of CIIs

Back 8

Long-term care facilities may dispense partials for up to 60 days.

Also up to 60 days in patients with documented terminal illness in any setting.

Front 9

Which controlled substances must be counted exactly when taking inventory?

Back 9

Schedule I, II, and opened bottles of III, IV, and V containing more than 1,000 pills.

Front 10

Which 222 forms need to contain only certain substances?

Back 10

Vet substances such as carfentanil, etorphine HCL, and Diprenorphine should be on forms only containing these substances

Front 11

True or False?
It is very important for the purchaser to record the number of containers received and the date received on copy 3.

Back 11

True

Front 12

How long must 222s be kept on file?

Back 12

2 years from the last use. (keep in mind refills)

Front 13

Federal Term:
Must enable a recipient to positively verify the signer without direct communication with the signer and subsequently be able to demonstrate the verifaication to the third party.

Back 13

Authentication

Front 14

Federal Term:
Must ensure that strong and substantial evidence is available to the recipient of the sender's identity, sufficient to prevent the snder from successfully denying having sent the data.

Back 14

Nonrepudiation

Front 15

Federal Term:
Must be able to determine whether the contents of the document have been altered during transmission or after receipt.

Back 15

Message Integrity

Front 16

Do individual pharmacists or do pharmacies need to register with the DEA every 3 years.

Back 16

The pharmacy is responsible

Front 17

What is the maximum % that a pharmacist can make as a controlled substance in solution, without registering with the DEA as a manufacturer?

Back 17

20% of complete solution

Front 18

What is the maximum % of prescriptions a pharmacy can distribute to another pharmacy or physician, without having to register as a distributor?

Back 18

5% of all prescriptions

Front 19

Which individuals are exempt from individually registering with the DEA?

Back 19

A practitioner that is an agent or employee of a hospital or other institution, acting under normal employment or officials of the Armed Services, Public Health Service, and Bureau of Prisons

Front 20

What would be reason for registration with the DEA to be suspended/revoked?

Back 20

Materially falsified the application
Conviction of a felony relative to controlled substances
A state license being suspended, revoked, or denied

Front 21

What is the DEA form 41?

Back 21

The form used to notify the DEA of intention to destroy controlled substances

Front 22

Under federal law, how long does the registrant have to notify the DEA of a theft or loss of controlled substances?

Back 22

Within 1 business day

Front 23

What form itemizes the losses during a theft or loss of controlled substances?

Back 23

DEA Form 106

Front 24

How can a physician obtain controlled substances to dispense at his or her practice?

Back 24

For CII's, have the provider complete a 222 form

For CIII - CV complete the invoice for both parties

Front 25

What can the pharmacist NOT change on the controlled substance prescription?

Back 25

The patient's name, controlled substance prescribed (except generic substitution), or the prescriber's signature

Front 26

What is the proper method for transferring a controlled substance prescription?

Back 26

VOID on the face of the script
Name, address, and DEA of the transferee pharmacy
Name of transferee pharmacist
date of transfer
Name of pharmacist transferring

Front 27

How many times can a controlled substance be transferred between pharmacies?

Back 27

One-time-only

Except in pharmacies using real-time online systems

Front 28

What is the proper method for receiving a transferred controlled substance?

Back 28

TRANSFER on the face of the script
Date of issue of the original script
Original # of refills
Original date of dispensing
# of refills remaining and locations of previous fills
pharmacy name, address, DEA#, and script # from which the script was transferred
Name of pharmacist transferring
pharmacy name, address, DEA#, and script # of orignal location

Front 29

Under what circumstances can a provider request additional refills on CIII-CV substances?

Back 29

Total quantity authorized does not exceed five refills or extend beyond 6 months from the date of issue.
The pharmacist initials and records the date, quantity authorized, and number of additional refills authorized on the reverse of the original prescription.
The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling

Front 30

What can a pharmacist do when a notice of inspection is served?

Back 30

The pharmacist has the right to refuse the inspection or withdraw consent at any time during the inspection.

Search warrants cannot be refused

Front 31

Can CII prescriptions be faxed?

Back 31

Yes, but the original must be obtained before release of prescription. Except for direct parenteral aministration, a hospice patient, or a patient in a longterm care facility

Front 32

What would the DEA number be for a physician authroized to dispense suboxone?

AB 9787079

Back 32

XB 9787079

Front 33

How do you verify the DEA # of a provider?

Back 33

2nd + 4th + 6th numbers x 2
1st + 3rd + 5th numbers + sum of previous

Last number should = last number in DEA number

Front 34

What are the limits on the sales of methamphetamine precursors?

Back 34

Daily sales limits: not to exceed 3.6 g PSE per day per purchaser
30-day Purchase Limits: Individuals are prohibited from purchasing more than 9.0 g PSE per 30 day period
Mail Order Limits: Not to sell more than 7.5 g PSE to a customer per 30-day period

Front 35

What are the base quantities in methamphetamine precursors?

Back 35

20.57 mg base in 25 mg Ephedrine HCl
24.65 mg base in 30 mg PSE HCl
23.22 mg base in 30 mg PSE SO4

Front 36

How does the FD&C Act define a drug?

Back 36

- articles recognized in the USP, Homeopathic Pharmacopeia of the US, or the NF, or any supplement to them
-articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals
-articles other than food intended to affect the structure or any function of the body
-articles intended for use as a component of a drug but does not include devices or their components, parts, or accessories

Front 37

Can a dietary supplement be used for diagnosis or cure?

Back 37

No

Front 38

What did the Durham Humphrey Amendment change?

Back 38

It created a statutory distinction between prescription and OTC drugs. ALSO it authorized refills on prescriptions, as well as oral prescriptions.
In addition, it deemed the prescription label as meeting the adequate directions for use requirement.

Front 39

What did the Kefauver-Harris Amendment change?

Back 39

This 1962 amendment was triggered by the Thalidomide disaster. It required more careful control of clinical studies and required drugs to be effective along with being safe. It also established Good Manufacturing Practices and increased the inspection authority of the FDA.

Front 40

What qualifies a drug as being adulterated?

Back 40

If the drug has been prepared, packed or held under unsanitary conditions where it may have been contaminated with filth or rendered injurious to health.
If the container is composed of a poisonous substance that may leech into the contents
If it contains an unsafe color additive
If the drug is not listed in the official compendium
If it is a drug and any substance has been added to reduce its quality

Front 41

What qualifies a drug to be misbranded?

Back 41

If its label or labeling is false or misleading
If the drug is listed in the official compendium but labeled and packed differently
The drug is subject to deterioration and the label does not bear statements
The drug is health-endagering if used in the manner suggested on the label
The drug is subject to PPPA and not packed accordingly
A pharmacist sells the drug without a prescription or refills a prescription without authorization

Front 42

What are the exceptions to the Tamper Resistant Packaging Requirement?

Back 42

Dermatologicals
Dentrifices
Insulin
Lozenges

Front 43

Who enforces the PPPA?

Back 43

The CPSC (Consumer Product Safety Commission) not the FDA

Front 44

What OTC products require child resistant packaging?

Back 44

Aspirin, Iron containing products, APAP, Diphenhydramine, ibuprofen, loperamide, lidocaine, dibucaine, mouthwashes, naproxen, ketoprofen, minoxidil, fluoride, and any drug that was previously prescription status

Front 45

What are the 3 types of drug recalls?

Back 45

Class I: possibility that serious adverse health effects or death can occur
Class II: product may cause temporary or medically reversible harm
Class III: product is not likely to cause adverse health effects

Front 46

What did the Waxman Hatch Amendment change?

Back 46

This amendment to the FD&C Act, also known as the Drug Price Competition and Patent Term Restoration Act of 1984, allowed the generic manufacturer to only show that the generic is bioavailable and bioequivalent to the innovator drug. Also, the amendment extended the patent life for the time of the FDA approval process.

Front 47

Look up Plan B laws.

Back 47

Pretty sure its 17 and older can get without a prescription.

Front 48

What Non-Physician Prescribers can write for C-II's to C-V's?

Back 48

CRNP - 72 hour supply of CII's and 30 days of III-V w/out refills
PA - 72 hour supply of CII for initial therapy or a 30-day supply of ongoing therapy (clearly stated for ongoing therapy). Also III-V with refills
Optomotrists - No C-II. III - IV analgesics not beyond 6 weeks.
Midwife - C-IIs for up to 72 hours and III-IV limited to 30 days and refills requiring approval from physician

Front 49

In PA, conditions of fire, water, or extreme temperature may be grounds for adulteration or misbranding according to the PA Controlled Substance Drug Device and Cosmetic Act. Who should be contacted if these conditions are believed to have altered a product?

Back 49

The PA Department of Health

Front 50

What drugs can be substituted with a B-rated drug?

Back 50

Nothing. Not even other B's.

Front 51

In PA, if a drug is A-rated, but it has a narrow therapeutic window, can another A-rated drug be substituted for the written substance?

Back 51

NO. And refills must be filled identically, unless the patient and prescriber provide authorization in advance.

Front 52

True or False? It is considered grossly unprofessional conduct to not have pocket card available when practicing.

Back 52

True

Front 53

What is the punishment for any person whom fails to disclose information to the Board within reasonable time?

Back 53

A fine not to exceed $1000.

Front 54

What is the penalty for a person committing an unlawful act?

Back 54

This person will be guilty of a misdemeanor and shall be senteced to undergo imprisonment for not more than one year or pay a fine of not more than $5,000, or both, and for each subsequent offense, shall be senteced to undergo imprisonment of not more than threee years or to pay a fine of not more than $15,000, or both.

Front 55

Schedule A Poisons

Back 55

Arsenic, Cyanides, Mercury, Thallium

Front 56

Schedule B Poisons

Back 56

HCl, Nitric Acid, Sulfuric Acid, Acetic Acid, Potassium and Sodium Hydroxide, Chloroform, Ether, Formaldehyde

Front 57

Sale of Poisons

Back 57

Buyer must be 16 y/o
Buyer aware of poisonous character and using for legitimate purpose
Schedule A poisons must be recorded

Front 58

What kind of setting can a pharmacist manage drug therapy?

Back 58

It must be in written agreement with a licensed physician and in an institutional setting

Front 59

How many pharmacies can a pharmacy manager serve at a time?

Back 59

Just 1

Front 60

How long can a pharmacy operate (without extensions or one-manager rule) without a pharmacy manager?

Back 60

15 days

Then the extensions and waivers get added to the 15 days

Front 61

Right now, can interns accept orders over the phone?

Back 61

No.

Front 62

Does the pharmacy manager or the pharmacy preceptor sign and date the interns protocol?

Back 62

The pharmacy manager

Front 63

As part of the $5,000 worth of non-proprietary drugs and devices, what supplies and equipment are still required under new regulations?

Back 63

Refrigerator in the prescription area (with a thermometer)
Original prescriptions (or images) must be maintained for 2 years from the date of the most recent filling

Front 64

What are the required pharmacy dimensions?

Back 64

Prescription area should be at least 250 square feet
Prescription counter should be at least 10 feet by 2 feet

If more than 2 pharmacists are on duty simultaneously, increase the required length by 5 feet for each additional pharmacist.

Front 65

What is a synonym for prescription drugs?

Back 65

Non-proprietary drugs

Front 66

What drugs are prohibited in the mail?

Back 66

Reconstituted antibiotics
Drugs generally known to be subject to deterioration due to heat, cold, agitation, etc.

Front 67

Under OBRA 90, when is PDR prescription counseling required for patients?

Back 67

PDR is required for retail, outpatient, and personal care home prescriptions. It is not required for inpatients, ER, nursing homes, and drugs dispensed by the provider.

Front 68

Look up Faxing prescriptions laws.

Back 68

PA is suposedly identical to Federal

Front 69

When are pharmacy permits renewed?

Back 69

Pharmacy permits are renewed every 2 years in odd-numbered years

Front 70

When are pharmacist licenses renewed?

Back 70

Pharmacist licenses are renewed every 2 years in even-numbered years

Front 71

Can e-prescribing be used for CII's?

Back 71

No

Front 72

What is a central processing center?

Back 72

A pharmacy operated under the direction of a pharmacist that processes information related to the practice of pharmacy and that engages solely in centralized prescription processing but from which drugs are not dispensed

Front 73

What is a central processing center exempt from?

Back 73

The requriement to maintain an inventory of $5,000 worth of non-proprietary drugs and devices
The minimum size requirements of a pharmacy
The requirement to have a sink used solely for pharmaceutical purposes

Front 74

What is drug therapy MGMT?

Back 74

Adjusting a drug regimen
Adjusting drug strength, frequency, of administration or route
Administration of drugs
ordering tests

Front 75

With drug therapy MGMT, how long does the pharmacist have to notify the physician of a change in therapy?

Back 75

72 hours

Front 76

How long must immunization documents be kept on file?

Back 76

2 years

Front 77

When notifying the physician of an administered immunization etc, what is the difference between an order and a written protocol?

Back 77

Both cases need to have the physician informed within 72 hours, but with an order, the pharmacist must also inform the physician of the route of administration.