Fed Flashcards
1
Q
What does the Federal Anti-Drug Abuse Act of 1988 include?
A
- It is prohibited for employees to have unlawful possessions of controlled substances in the work place.
- Any employee who has been convicted of criminal possession of drugs must inform their employer of their conviction within 5 days.
- Employers have the right to take appropriate action in order the keep the work place free of drugs.
2
Q
Why was HIPAA enacted?
A
- To control the dissemination of patient information.
- To only disseminate patient information upon authorization of the patient
- To keep personal identifiable health information protected when transmitted or maintained by electronic or other medias.
3
Q
Who is responsible for the Medicaid and Medicare programs?
A
Centers for Medicare & Medicaid Services (CMS)
4
Q
Who issues licenses for pharmacies?
A
State Board of Pharmacy
5
Q
Can a drug product be exempt from demonstrating therapeutic equivalence?
A
Yes, but only under the grandfather clause.
6
Q
Do prescription labels need to have an NDC number on them?
A
No this is not mandatory. The same goes for package labels and individual dosage units.
7
Q
When does a unit dose package that is prepared from a bulk container or a commercial drug product expire?
A
25% of the remaining time between the date of repackaging and the manufacturer’s expiration date, but in no case can the dating applied to the repackaged unit exceed six months.
8
Q
What should the supplier do if a DEA 222 Form cannot be filled?
A
Return copies 1 & 2 to the purchaser and state the reason for not filling.
DEA implements a new single-sheet format for DEA Form 222. This rule includes a “sunset date” of October 30, 2021—the date after which use of the triplicate forms will not be allowed.
If a DEA Form 222 cannot be filled for any reason, the supplier must return the original DEA Form 222 to the purchaser with a statement explaining the reason the order could not be filled. For electronic orders, if the order cannot be filled, the supplier must notify the purchaser and provide a statement as to the reason; if the order is refused, a statement that the order is not accepted is sufficient.
9
Q
Who does the Americans with Disabilities Act (ADA) of 1990 apply to?
A
- All companies employing 15 or more people.
- All companies receiving or not receiving federal financial assistance.
- Replaced the word “handicapped” with “disabled”.
10
Q
What is the USP/NF?
A
United States Pharmacopoeia/National Formulary (USP/NF). This serves as a reference and revisions are published bimonthly in The Pharmacopoeia Forum (PF)
11
Q
What is tamper-evident?
A
Packaging designed to prevent foreign materials from getting into the final product.
12
Q
What should you know in regards to take home medication for a patient in a comprehensive treatment program?
A
- All medication must be labeled with the name, address and phone number of the treatment center.
- All medication must be packaged in child-resistant containers.
- Narcotics should only be given to a patient if there has reasonable judgment by the program physician regarding the patient being responsible in handling narcotic drugs.
13
Q
In an emergency situation, what should the pharmacist know in regards to dispensing a Schedule II medication upon receiving oral authorization from a prescribing practitioner?
A
- The prescription must immediately be reduced to writing by the pharmacist and must contain all required information, with exception of the prescribers signature.
- If the pharmacist does not know the prescriber, he/she must make all reasonable efforts to contact them to determine that the oral order is legit.
- If the prescriber fails to deliver a written prescription within seven days after authorizing the emergency oral prescription, the pharmacist needs to notify the nearest DEA office to report this.
14
Q
How do clinical human trials work?
A
- There are 3 phases before the final approval of a drug by the FDA
- There is one phase after the drugs has been marketed.
- A drug must complete each phase successfully before progressing to the next phase.
15
Q
What is VIPPS?
A
The Verified Internet Pharmacy Practice Sites. Established in 1999 for the public concern of the safety of pharmacy practices on the Internet. A coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups provided their expertise in developing the criteria which VIPPS accredited Pharmacies follow.
16
Q
What is a requirement if an Internet pharmacy wants to be VIPPS accredited?
A
To be VIPPS accredited, a pharmacy must comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals. In addition, pharmacies displaying the VIPPS seal have demonstrated to NABP compliance with VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists.
17
Q
How would you label a drug container that does not display the legend “Rx only”?
A
Misbranded
18
Q
What are orphan drugs?
A
Drugs used to treat diseases that relatively affect very few people.
19
Q
What form would a pharmacy need to purchase 95% Ethanol for routine compounding?
A
Form ATF-11
20
Q
What drug titles are used when writing a prescription for a drug product for dispensing?
A
Trade name & brand name
21
Q
Where would you treat a patient requiring rehabilitation or a lower level of medical care needed for a hospital?
A
Skilled Nursing Facility (SNF)
22
Q
What are the classifications of controlled substance schedules based on?
A
The drugs potential for abuse and dependence
23
Q
Does a prescriber need a prescription to administer or dispense a Schedule III, IV, or V controlled substance to a consumer in the course of their professional practice?
A
No
24
Q
Can a pharmacist dispense drug samples given to them from pharmaceutical companies?
A
No. A physician is allowed to give them to their patients, but a pharmacist should not give out samples to their customers.
25
What did the Pure Food and Drug Act of 1906 regulate?
Prevents the manufacture, sale, or transportation of adulterated or misbranded or poisonous or
deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.
26
What do licensed private practitioners and community pharmacists do in a medication unit of a narcotic treatment program?
A medication unit is a facility established as part of a narcotic treatment program. In a medication unit,
private practitioners and community pharmacist are permitted to administer and dispense
27
Can pharmacies sharing a real-time online database transfer Schedule III, IV, or V prescriptions for refills?
Yes, refill prescriptions, up to the maximum limit by law, can be transferred given the following criteria:
- The transfer must be communicated directly between 2 licensed pharmacists.
- The transferring pharmacist must:
* Add information to the electronic prescription record that the prescription has been transferred.
* Add to the electronic prescription record; the name, address and DEA number of the pharmacy and the name of the pharmacist receiving the prescription.
* Record the date and the name of the pharmacist transferring the information.
* Provide the receiving pharmacist the following information in addition to the original electronic prescription data:
* Date of original dispensing
* Number of refills remaining and the dates and locations of previous refills
* The transferring pharmacy's name, address, DEA #, and Rx # for each dispensing
* Name of the pharmacist transferring the prescription
* The name, address, DEA # and Rx # from the pharmacy that originally filled the prescription if different
- The receiving pharmacist must create an electronic record for the prescription that includes the
receiving pharmacist's name and all of the information transferred with the prescription (listed above).
-The original and transferred prescriptions must be maintained for a period of 2 years from the last refill.
28
What forms need to be filed simultaneously, with both the FDA and the state authority, when trying to obtain approval for a
narcotic treatment program?
- Form FDA-2632: This is an application for approval to use narcotic drugs in a treatment program and it is
to be signed by the program director, in duplicate.
- Form FDA-2633: This is a medical responsibility statement for use of narcotic drugs in a treatment
program and it is to be signed by each licensed physician authorized to administer or dispense narcotic
drugs, in duplicate.
29
What group of patients should generally NOT be give LAAM in treatment of narcotic dependence?
Pregnant women & people under the age of 18. Levacetylmethadol (LAAM) is a synthetic opioid similar in structure to methadone. It is indicated as a second-line treatment for the treatment and management of
opioid dependence if patients fail to respond to drugs like methadone or buprenorphine.
30
What is a Type S drug?
Type S drug indicates that it is similar to other drugs on the market.
31
Who is responsible for designating non proprietary assigned to pharmaceuticals marketed in the U.S.?
United States Adopted Name (USAN)
32
What conditions must be met with an Automated Data Processing System?
An Automated Data Processing System is a computer used for storage and retrieval of refill information
for prescription orders for Schedule III, IV, or V controlled substances. It must provide online retrieval of original prescription order information for all prescriptions currently authorized for refilling. It also must provide online retrieval of the current refill history for prescription orders authorized for refill in the past
six months.
33
If you make an error on a DEA Form 222, can you correct it and put your initials next to it?
No, corrections cannot be made on a DEA Form 222 A new DEA Form 222 must replace it.
34
Can Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness be
maintained in a computerized system?
Yes, given the computerized system is capable of the following:
- Output data of the original prescription
- Immediate updating of the prescription record each time a partial filling of the prescription is done.
35
How would a physician prescribe a Schedule II medication for one of their hospital patients?
By sending in a written or faxed medication order. (A prescription is an order for medication which is
dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for
immediate administration to the ultimate user).
36
How are cosmetic products intended for use in body cavities, such as mouthwashes and vaginal creams, packaged?
In tamper-resistant packaging
37
When can pharmacies compound drugs extemporaneously?
- When the drug products compounded are not compounded versions of FDA approved drug products.
- if the ingredients included in the compounded dosage form meet official standards of the USP/NF
- If the pharmacy does not actively solicit business for specific drug products by advertising or by
otherwise promoting their compounding capabilities. However, they may advertise to both the public
and health professionals that it specializes in prescription compounding.
- The quantity prepared is reasonable for filling either existing prescriptions or those anticipated based
upon prescribing habits or prescribers and prescriptions already on file.
- The dosage forms prepared are not being compounded, provided or sold to other pharmacies or third-
parties such as physician's offices.
- The pharmacy does not attempt to compound a drug product that is on the list of products that have
been withdrawn or removed from the market because they were unsafe or ineffective.
38
Who is in charge of regulating advertising and/or labeling of cosmetics?
The Federal Trade Commission (FTC) regulates all forms of advertising. The FDA regulates the content
and form of food labeling, cosmetic labels, dietary supplement labels and drug labels. Labels are simply
special form of advertising, so both FTC and FDA regulate them in one way or another.
39
What did the Durham-Humphrey Amendment of 1951 make it mandatory for manufacturer's to provide?
The Durham-Humphrey Amendment of 1951 defined two categories for medications, legend (rx) and OTC.
It required medications that should be used only under the supervision of a health practitioner to carry the
statement "Caution: Federal law prohibits dispensing without a prescription".
It also mandated that there must be "adequate directions for use", on the manufacturer's label for the
class of drugs which do not require medical supervision to be used safely (OTC's).
40
Who do you report adverse effects of controlled substances and medical devices to?
MedWatch is the FDAs reporting system for adverse events, founded in 1993. An adverse event is any
undesirable experience associated with the use of a medical product. The MedWatch system collects
reports of adverse reactions and quality problems, primarily with drugs and medical devices.
41
What drug schedule does Phenobarbital fall into?
Schedule IV
42
What did the FDCA of 1938 address?
The Federal Food, Drug and Cosmetic Act (FDCA) is a set of laws passed by Congress in 1938 giving
authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and
cosmetics. The proof of fraud intent was no longer required to stop false claims or misbranding for
drug products. Authority was granted for factory inspections and warnings of habit-forming drugs were
required on all drug product labeling.
43
What determines OTC status on drugs?
- Drugs that are safe for use without the supervision of a physician
- Drugs that meet suitable conditions for self-diagnosis
- Drugs that have adequate written directions for self use
44
How many days can a narcotic drug be administered for a short term detoxification from narcotic drugs?
The narcotic drug can be administered daily, under close supervision, for no longer than 30 days. Dosages
should be tapered down over this period of time.
45
Can a pharmacist dispensing solid oral medications use their discretion as to the beyond use dating for the product?
Yes, as long as it doesn't exceed the expiration date stated on the manufacturer's label.
46
How would the FDA classify a unit dose drug product that does not have an expiration date on the label?
Misbranded
47
What are some of the major objectives of a drug formulary?
- Reducing Inventory
- To allow therapeutic substitution
48
Can manufacturers of OTC products designate one size of a product as a non-compliant container?
Yes, provided that the product contains a conspicuous warning label that states:
- This package is for households without young children or package not child resistant
49
What did the Kefauver-Harris Amendment of 1962 declare?
It declared that all new drugs marketed in the U.S. had to be shown to be safe and effective. This not only
applied to new drugs, it also applied to products that were approved between the years of 1938 and 1962.
50
What type of drugs fall into Pregnancy Category D?
- Drugs in which there has been positive evidence of risk to the human fetus, mainly based upon adverse
reaction data from either investigational or marketing experiences.
- Drugs that should be administered in pregnant women ONLY if the potential benefits of the drug are
greater than the potential risk.
51
What is the maximum volume of Ipecac Syrup that can be sold without a prescription?
30 mL
52
Which Act provided civil rights protection to individuals with epilepsy?
Americans with Disabilities Act (ADA) provided civil rights protection to individuals with disabilities which
includes: Epilepsy, Paralysis, WV infections, AIDS, Mental Retardation and Alcoholics.
53
What is a Narcotic Treatment Program?
An organization, or person, that administers or dispenses a narcotic drug to a drug addict for the purpose
of maintenance or detoxification treatment. They must be registered with the DEA to use a narcotic drug
for the treatment of a narcotic addiction.
54
What must be affixed to the prescription package label in the event of a pharmacist filling a Schedule II prescription?
- The pharmacy name and address, date of filling and the serial number of the prescription
- The name of the patient and prescribing practitioner
- Directions for use and other cautionary statements if required by law
- A warning stating: "Caution: Federal law prohibits the transfer of this drug to any person other than the
patient for whom it was prescribed"
55
Who is in charge of approving a new drug before it can be administered to humans?
FDA
56
What should happen when a marketed drug product exhibits problems?
The drug manufacturer is encouraged to issue a drug recall notice.
57
How should inventories and records of Schedule I & ll controlled substances be kept?
- Inventories and records must be maintained separately from all other records of the pharmacy
- Prescriptions must be maintained in a separate prescription file
58
What needs to be imprinted on each commercial tablet intended for oral intake?
An identification code
59
What group of patients are protected from accidental poisoning by the Poison Prevention Packaging Act (PPPA)?
Young children
60
Can a patient request the pharmacist to not use a poison prevention closure on their prescription?
Yes
61
Can a registrant allow an unregistered individual to execute DEA Form 222 orders?
Yes, a registrant may authorize one or more individuals, whether or not located at his or her registered
location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing
a power of attorney for each such individual, if the power of attorney is retained in the files, with executed
Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The
power of attorney must be available for inspection together with other order records.
62
When is Phase IV of clinical trials conducted?
After the drug has been marketed.
63
What is HMS?
Homeopathic Pharmacopoeia of the United States (HPUS) is published by a private organization or
convention and information is updated for homeopathic products or remedies on a regular basis.
64
Can a manufacturer make changes to a drug or a drug label after it has been approved?
Companies are allowed to make changes to drugs or their labels after they have been approved.
To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug,
a company must submit a supplemental new drug application (sNDA). The supplement type refers to the
kind of change that was approved by FDA. This includes changes in manufacturing, patient population,
and formulation.
65
In the Controlled Substance Act (CSA), what does maintenance treatment refer to?
Maintenance treatment refers to the dispensing of a narcotic drug for the treatment of an individual that
has a dependence on heroin or other opioid drugs.
66
What should a pharmacist do if he/she is unable to supply the full quantity called for in a written or emergency oral prescription for a Schedule II controlled substance?
- He/she must make a notation of the quantity supplied on the face of the written prescription or the
written record of the emergency oral prescription. The remaining portion of the prescription may be filled
within 72 hours of the first partial filling.
-If the remaining portion is not or cannot be filled within 72 hours, the pharmacist must notify the
prescribing individual practitioner.
-No further quantity should be supplied beyond 72 hours without a new prescription.
67
What are the federal guidelines for determining an expiration date for a repackaged drug by a pharmacy?
6 months or 25% of the time remaining until the expiration date of the original package, which ever is
shorter.
68
What actions are permissible under the FDA rules for prescription compounding by a pharmacy?
- Due to a supreme court ruling in 2002, pharmacists are allowed to advertise compounding services
including specific drugs. They still must follow state laws on kickbacks and other advertising.
69
What form does a pharmacy requiring greater volumes of alcohol use to purchase tax-free alcohol?
Form ATF-1447
70
What are drug products that have similar pharmacokinetic properties considered to be?
Bioequivalent
71
What are the objectives for Phase 1 in clinical trials of a new drug?
- To evaluate the drug's toxicological, pharmacokinetic and pharmacological properties. A small group of
healthy persons is selected for this purpose.
-To assess safety of the drug in humans.
72
When is the partial filling of prescription orders for Schedule III, IV or V permissible?
- When the dispensing pharmacist records on the back of the prescription for each partial filling:
- Date of partial filling
- Amount of drug dispensed
- Dispensing pharmacist's initials
- When the total quantity dispensed, in ALL partial fillings, does not exceed the total quantity prescribed
- When no dispensing occurs beyond six months after the date of issuance of the prescription
73
What are some possible penalties for violations of HIPPA?
- For civil violations: $100 per offense with a cap at 525,000 in a calendar year
- Up to $50,000 and 1 year imprisonment if a person knowingly obtains or discloses protected health
information
-Up to $100,000 and 5 years imprisonment if a person obtains protected health information under false
pretenses
- Up to 5250,000 and 10 years imprisonment if a person obtains or discloses protected health information
with intent to sell, transfer or use information for personal gain or malicious harm
74
What patients qualify for the administration of investigational new drugs?
Treatment Investigational New Drugs (Treatment INDs) allow the administration of an investigational new
drug to patients who have not been enrolled in the new drug's clinical trials program. Patients also need
to be in an imminent life-threatening stage of an illness for which presently there is no known cure or
where the presently used drugs do not appear to be effective.
75
What must a supplier do in the event of refusing to accept a DEA Form 222?
The supplier must return copies 1 & 2 to the purchaser with a statement as to the reason. When this is
received by the purchaser, copies 1 & 2 of the DEA Form 222 and the statement of the reason of refusal
must be attached to copy 3 and retained in the files of the purchaser.
After Oct. 30, 2021 A supplier may refuse to accept an order for any reason. If a supplier refuses to accept
an order, a statement that the order is not accepted is sufficient.
76
What does the supplier of controlled substances do with DEA Form 222?
The supplier must retain copy 1 of the DEA Form 222 for his/her own records and forward copy 2 at the
close of the month during which the DEA Form 222 is filed, to the special agent in charge of the DEA office in the area in which the supplier is located. After Oct. 30, 2021. The supplier must retain the original DEA Form 222 for the supplier's files. Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under 1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to DEA.Orderforms@usdoj.gov. The copy must be forwarded at the close of the month during which the
order is filled.
77
What is typically used in the treatment of narcotic dependence?
LRAM or Methadone
78
What jurisdiction does the enforcing the PPPA fall into?
Consumer Product Safety Commission (CPSC)
79
What was the intention for the FDA to further designate some AB products as AB1, AB2, AB3, etc?
These subcategories are intended to categorize drug products, which previously would not be considered
bioequivalent, into bioequivalent groups.
80
What substances does the Poison Prevention Packaging Act of 1970 apply to?
Hazardous household substances, OTC products and prescription drug products.
81
M How often must a DEA registration be renewed for manufacturers? Distributors? Dispensers? Prescribers?
Annually
Annually
3 years
3 years
82
What provisions are included in the Prescription Drug Marketing Act of 1987?
-Requiring proper storage of drugs and maintenance of appropriate distribution records
-Prohibiting companies from shipping drugs between states without being registered in the state from
which they are being shipped from
-Prohibiting drugs from being re-imported into the U.S. except by the manufacturer of said drugs
Who is Medicaid financed by?
Medicaid is financed by state-federal agencies jointly.
83
What is Durable Medical Equipment (DME)?
- Equipment that can stand repeated use
- Equipment that is primarily used for medical purpose
- Equipment that is appropriate for use in a home (i.e. wheelchairs, oxygen tanks)
84
Distinctive generic and proprietary names are assigned to new drugs based on what criteria?
```
The name should be short, distinctive and not likely to be confused with other existing names. The name
should also provide some indication of the therapeutic or chemical class to which the drug belongs.
```
85
Which Amendment required safety and efficacy studies on medical devices including diagnostics and laboratory products prior to the marketing of the device?
Medical Device Amendment of 1976
86
Can a resident physician in a hospital prescribe controlled substances without a DEA registration number?
Yes, they may prescribe controlled substances using the hospital's DEA number and assigned suffix.
87
What do clinics providing treatment with LAAM need to specify to women?
- The clinic must advise the risks of LAAM in all patients of child bearing potential.
- Medical evaluation must be made available to all patients who became pregnant while taking the drug.
- Must perform initial pregnancy test for each prospective female patient of child bearing potential before admission to LAAM comprehensive maintenance treatment and monthly pregnancy tests performed thereafter on such female patients in LAAM comprehensive maintenance treatment.
88
How many volumes are there for the United States Pharmacopoeia Dispensing Information (USP DI)?
There are 3 volumes containing a variety of information:
- Volume 1 includes Drug Information for the Health Care Professionals
- Volume 11 includes advice for the patient
- Volume 111 includes Approved Drug Products with Therapeutic Equivalence Evaluations
89
Who is allowed to communicate a prescription for a controlled substance issued by a practitioner, to a pharmacist?
An employee or agent of the individual practitioner
90
Can an institutional practitioner-pharmacist administer or directly dispense a Schedule Ill, IV or V controlled substance?
Yes, but only pursuant to the following:
- An order for medication made by a prescriber which is dispensed for immediate administration to the ultimate user
- A written prescription signed by a prescriber, or a fax of a written prescription or order for medication
transmitted by the prescriber or the prescriber's agent to the institutional practitioner-pharmacist.
- An oral prescription made by a prescriber and promptly reduced to writing by the pharmacist while
containing all information of the written prescription with exception to the prescribers signatures.
91
What is included in the FDA Modernization Act of 1997?
- Provisions for the fast track review of some New Drug Application submissions to expedite approval of
new drugs used to treat serious or life-threatening conditions.
- Clarifications of the conditions under which pharmacies can perform extemporaneous compounding of prescriptions.
- Encouragement for manufacturers to conduct research for new uses of drugs and to submit
supplemental NDAs for these uses.
92
What was the objective of the Orphan Drug Act of 1983?
To reduce the cost of orphan drugs.
93
When should the inventory of controlled substances be taken?
Inventory should be taken at the opening or closing of the business on the inventory date. Every registrant
must take an inventory of all stocks of controlled substances on hand on the date he/she first engages
in the manufacture, distribution or dispensing of controlled substances. After the initial inventory, the
registrant is required to take a new inventory at least every two years. When the status of a non-controlled
substance is changed to a controlled substance, each registrant who possesses the substance must take
an inventory of all stocks of the medication on hand and proceed to include this medication on all future
inventories.
94
What is generally included on a drug package insert?
Clinical Pharmacology, Indications and Usage, Contraindications, Warnings, Precautions, Adverse
Reactions, Drug Abuse and Dependence, Overdosage, Dosage and Administration, & How Supplied
95
What conditions need to be met in order for a pharmacy to provide customized patient medication packages (Med Paks)?
The prescriber, patient or caregiver must first consent on receiving a Med Pak. The package will normally
contain several solid oral dosage forms with directions that specifically indicate the time of day in which
the contents of each container are to be taken. The usual information of the unit dose package must be
on the package, along with a serial number for the Med Pak in addition to the prescription serial numbers
for each drug product. The expiration date for the Med Pak is based upon the "beyond-use" dating
principle, but no more than 60 days from when the Med Pak was prepared.
96
What does the transferring pharmacist need to do, when transferring Schedule III, IV and V controlled substances refill
prescriptions to another pharmacy?
The transferring pharmacist must write the word VOID on the face of the invalidated prescription. He/She
must record the name, address and DEA registration number of the pharmacy to which it was transferred
to and the name of the pharmacist receiving the prescription information on the reverse side of the
invalidated prescription. He/She must also record the date of the transfer along with the name of the
pharmacist that is transferring the prescription information.
97
What organization accredits pharmacy schools in the United States?
Accreditation Council for Pharmacy Education (ACPE) is a non-profit accreditation agency accrediting
professional degree programs in pharmacy and providers of continuing pharmacy education.
98
What is the purpose of MedWatch?
- To educate all health professionals about the critical importance of being aware of, monitoring for and
reporting adverse events and problems with medical products to the FDA and/or manufacturer.
- The ensure that the new safety information is rapidly communicated to the medical community to enable
improvements in patient care.
- To enhance the effectiveness of post-marketing surveillance of medical products used in clinical practice and rapidly identify significant health hazards associated with these products.
99
What is DEA Form 222a used for?
To requisition DEA Form 222
100
In the absence of stability data, in regards to expiration dating or beyond-use, what guidelines should a pharmacist follow?
- Non aqueous liquids and solids: No more than 25% of the time remaining on the commercial product or a
maximum of 6 months (whichever is less)
- Aqueous solutions made from solids obtained from manufactured drug products: 14 days when stored at
a cold temperature.
- For all others: the time duration of therapy (not lasting more than 30 days).
101
What did the Medical Device Amendment of 1976 provide?
- Better classification of medical devices according to their specific function
- Establishment of performance standards and pre-market approval requirements
- Conformance with Good Marketing Practices (GMP) standards and adherence to the record and
reporting requirements
102
What forms are used for renewal of registration of registrants to manufacture/distribute/dispense controlled substances?
DEA Forms 224a, 225a & 363a
103
What must be identified on each commercial oral capsule, as an imprint?
The company name, drug and strength of the drug
104
Can products under the Dietary Supplement Health Education Act (DSHEA) be marketed without proving their efficacy?
Yes. However, the FDA or FTC may challenge these products if there is evidence that they are ineffective
for the advertised or labeled use. Products currently on the market do not have to be proven safe, however, the manufacturer must provide reasonable assurances that no ingredient in the product presents a significant or unreasonable risk of illness or injury.
105
What does the title "Institutional Practitioner" refer to?
This title does not include pharmacy. It refers to a hospital or other entity (other that the individual)
licensed, registered or otherwise permitted to dispense a controlled substance in the course of
professional practice.
106
How many digits does the NDC of a specific drug product consist of?
10 or 11
107
How is the Orange Book available?
```
Hard Copy (updated each yearly publication)
Electronic Form (updated continuously)
```
108
In order for a hospital pharmacy to dispense controlled substances, who must be registered with the DEA?
The hospital pharmacy
109
What authority initiates legal action in the case of illegal Internet sales of drug products?
FDA
110
What is the National Drug Code (NDC)?
The NDC is a classification system for identifying a specific drug product. It is used nationally for
reimbursement and identification of drug products.
111
What is the major objective of an IND approval?
To protect both rights and safety of the people of which the drug will be tested.
112
Under what circumstances would the FDA generally approve two competing drug products?
If the drugs meet appropriate bioequivalency standards and do not present a potential problem.
113
What is a Class Ill drug recall?
This is issued for the drug product which is unlikely to cause any adverse health consequence and is
sometimes handled with written notices.
114
When is a prescriber or his agent permitted to fax a schedule II prescription that serves as the original written prescription?
- When prescribing narcotic substances to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular; subcutaneous or intraspinal infusion.
-For a resident of a Long Term Care Facility (LTCF)
- For a patient residing in a hospice facility certified or licensed by the state. In this case, the practitioner
or agent must notate on the prescription that the patient is a hospice patient.
115
Where can health professional obtain bioequivlence information from?
- FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book)
- Monthly supplements issued for The Orange Book
- Several other reference sources to determine the status of a specific drug product that includes-
- USP/DI Volume Ill plus supplements
- Facts and Comparisons
- FDA's website
116
Do labeling requirements apply when prescribing a Schedule Ill, IV or V to a patient in an institution?
No; provided that the following criteria is met:
- The controlled substance is dispensed for not more than a 34-day supply or 100 dosage units,
whichever is less, at one time.
- The controlled substance is not in the possession of the ultimate user prior to the administration.
- The institution maintains appropriate safeguards and records regarding the proper administration,
control, dispensing, and storage of the controlled substance.
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What federal department is responsible for the DEA
The Department of Justice
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What are the FDCA requirements for the labeling of every prescription?
- Name of patient
- Prescription serial number
- Date when dispensed
- Directions for use of the drug product by the patient
- Name and address of the pharmacy
- Any special cautionary statements that may be appropriate
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What must a pharmacist maintain when dispensing a controlled substance without a prescription?
A bound record book containing the following:
- Name and address of the purchaser
- Name and quantity of the controlled substance
- Date of the purchase
- Name and initials of the dispensing pharmacist
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What is the Safe Medical Device Act of 1990?
A legislation which was designed so that the FDA could quickly be informed of any medical product that
has caused or suspected to have caused a serious illness, injury or death. This gave the FDA authority
to order device recalls. Nursing homes, hospitals and other facilities that utilize medical devices were
required to report information to the FDA pertaining to medical devices that contributed to the death or
serious injury of a patient. Manufacturers of devices were required to conduct post market surveillance on
all permanently implanted devices whose failure might cause serious harm or death.
121
How long should a PPI be supplied to a patient that you are dispensing Accutane to?
It should be supplied prior to the administration of the first dose of Accutane and every 30 days after as
long as the medication continues.
122
Does the DEA require the pharmacist in charge to report theft or significant loss of any controlled substance?
Yes - The DEA requires the loss of controlled substances to be reported within 1 business day of the
discovery and DEA form 106 to be completed. It is preferred that DEA form 106 be completed online.
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Can Mid-Level Practitioners dispense a controlled substance in the course of their professional practice?
Under certain circumstances, depending on the state, some Mid-Level Practitioners are authorized to
dispense controlled substances.
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Who are considered Mid-Level Practitioners?
Ambulance Service, Animal Shelter, Certified Chiropractor, Doctors of Oriental Medicine, Euthanasia
Technicians, Homeopathic Physician, Medical Psychologists, Naturopathic Physician, Nursing Homes,
Optometrists, Physician Assistants, Registered Pharmacists
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When is the partial filling of prescription orders for Schedule II permissible?
According to Federal Law, a partial fill of a C-II drug is allowed if the pharmacist is unable to supply a
full quantity, but the balance must be filled within 72 hours or the balance becomes void. According to
CARA (Comprehensive Addiction and Recovery Act of 2016) states that a patient may request a partial
fill of a C-II, and the pharmacist may fill the balance within 30 days from the date the prescription was
written. Note: Most states restrict the partial fill of CII drugs. Please review the state you are testing
for on this subject.
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Can a prescriber issue multiple Schedule II prescriptions to be filled at a later date?
-Each prescription issued is for a legitimate medical purpose by an individual practitioner acting in
the usual course of his/her professional practice.
- The individual practitioner must provide written instructions on each prescription indicating the
earliest date on which a pharmacy may fill each prescription
-The issuance of multiple prescriptions is permissible under applicable state laws.
-The individual practitioner complies fully with all other applicable requirements under the Controlled
Substances Act and implementing regulations, as well as any additional requirements under state law.
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What changes may a pharmacist make to a prescription written for a Schedule II controlled substance ?
On Schedule II prescriptions the pharmacist may NOT change the following items:
- Patients Name
- Name of drug (except generics)
- Physicians Name
The Pharmacist may make the following changes with verbal permission from the prescriber:
- Dosage form
- Drug Strength
- Directions for use
- Drug quantity
- Issue Date
The Pharmacist must write the changes on the prescription, document the verbal changes, note the
verbal consultation, date and initial Rx.
128
What schedule are any hydrocodone combination products?
All hydrocodone combination products were rescheduled from Ill to Schedule II as per the DEA final
decision in 2014.
