Federal Law Questions
"New Drug"
"Any drug, the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof."
The Food and Drug Administration Modernization Act changed the labeling requirement for legend drugs, thereby authorizing the use of the "Rx Only" symbol... prior to that the label read:
"Caution: Federal law prohibits dispensing w/o a Rx"
FDCA states that compounding...
"does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer"
To protect the public, the United States Department of Health and Human Services requires the disclosure of material facts relating to any drug subject to an abbreviated drug application. Knowingly failing to disclose this information could cost an individual up to how much money in civil penalties?
$250,000
Factors to consider where there is theft in the pharmacy
(1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (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; (6) Local trends and other indicators of the diversion potential of the missing controlled substance. Please note: The language requires reporting a theft OR a significant loss. The language does not say that the theft must be significant.
Labeling requirements for CS in an institution:
(1) not more than 7-day supply of the controlled substance is dispensed at one time; (2) the controlled substance is not in the possession of the ultimate user prior to the administration; (3) the institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and (4) the system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.
"Authorization required: Marketing. (i) [A] covered entity must obtain an authorization for any use or disclosure of protected health information for marketing, except if the communication is in the form of:
(A) A face-to-face communication made by a covered entity to an individual; or (B) A promotional gift of nominal value provided by the covered entity. . . . "
Distribution by dispenser to another practitioner or reverse distributor. (a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner provided that --
(i) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance; (ii) The distribution is recorded by the distributing practitioner in accordance with §1304.22(c) of this chapter and by the receiving practitioner in accordance with §1304.22(c) of this chapter; (iii) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and (iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and §1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.
The Controlled Substance Registrant Protection Act (CSRPA) was passed to provide federal investigation of CS thefts and robberies if which of the following occured?
-interstate commerce was involved -a person was killed as a result -the replacement cost of the CS is >$500
For a retail pharmacy to transmit a prescription electronically to a central fill pharmacy, which of the following must happen?
. The retail pharmacy must ensure that all information required to be on a prescription is transmitted to the central fill pharmacy. B. The retail pharmacy must write "CENTRAL FILL" on the face of the prescription. C. The retail pharmacy must maintain the original prescription for a period of 2 years from the date the prescription was last refilled. D. All of the above**ANSWER**
In terms of compounding, a pharmacy MAY compound
1) based on hx of prescribing from a licensed prescriber 2) compound in response to an oral Rx 3) a dose of commercially available product in an emergency 4) compound a dose of commercially available product in response to a drug shortage
A CS II-V may be dispensed by a pharmacist w/o a Rx provided that...
1) dispensing is madeonly by a pharmacist OR even an intern! 2) not more than 240 cc (8 oz) of any such CS containing opium, nor more than 120 cc (4 ox) of any other such CS nor more than 48 dosage units of ANY CS containing opium, nor more than 24 dosage units of any other such CS may be dispensed at retail to the same purchaser in any given 48 hour period. 3) the purchaser is at least 18 years old 4) the RPh requires every purchaser of a CS under this section not known to him to provide ID (including age where appropriate) 5) A bound record book for dispensing CS under this section is maintained by the pharmacist, which book shall contain the name/address of the purchaser, the name and quantity of CS purchased, the date of each purchase, the name/initials of dispensing RPh to the purchaser 6) Rx is not required for distribution/dispensing of substance pursuant to any other Federal, State, or local law 7) Central pharmacies may not dispense CS to a purchaser at retail pursuant to this section DATE of BIRTH not required to be documented!!
The following may indicate a forged Rx
1) handwriting is too legible 2) directions are written in full with no abbreviation 3) qty, directions, dosages are unusual 4) rx appears to be photocopied
The following people may compound according to FDCA:
1) licensed RPh in a state-licensed pharmacy 2) a licensed R.Ph in a federal facility 3) licensed physician
A pharmacy registrant that transfers its business operations to another pharmacy registrant must submit the following...
1) name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor) 2) name, address, registration #, and authorized business activity of the person acquiring the business (registrant-transferee) 3) whether the business activities will be continued at the location registered or moved to another location (if latter, then new address should be listed) 4) date of transfer of CS On day when CS are transferred, a complete inventory must be taken and a copy of the inventory must be included in the records of BOTH the person transferring and person acquiring
DEA 106 form requires following information
1) name/address of reporting pharmacy 2) type of theft (armed robbery) 3) name/phone number of the local police dept (if it was notified)
What is required on a written Rx for a CS?
1) pts full name 2) pt address 3) qty prescribed 4) dosage form
in 2007, the US Congress passed two acts relating to children...
1) the Best Pharmaceuticals for Children Act of 2007 2) Pediatric Research Equity Act of 2007
The DEA requires pharmacies to report a significant loss of CS. Which of the following factors is considered when determining a significant loss?
1) the actual quantity of CS lost in relation to type of business 2) a pattern of losses over specific time and whether these losses appear to be random 3) the specific CS lost and whether these controlled substances are likely candidates for diversion 4) local trends and other indicators of the missing CS potential
To issue multiple CS II prescriptions for the same patient,
1) the patient is authorized to receive at most, a 90-day supply 2) Each Rx is issued on a separate Rx blank
Which of the following terms is defined as any adverse event associated with the use of a drug in humans, whether or not the event is considered drug related?
Adverse drug experience
Filing filled Rx in 1/3 ways
1. Pharmacist keep two files: one for CS II and the other one for CS III-V. If this method is chosen, all federally controlled drugs (III, IV, V) must be stamped with large red C, no less than 1" high in the lower right hand cornder to make those Rx readily retreivable.
DEA can suspend, deny, or revoke a DEA registration if registrant..
1. materially falsified the registration 2. has been convicted of a felony relating to a CS or a list I chemical 3. had a state license/registration suspended, revoked, or denied by a competent state authority and is no longer authorized to engage in the mfr, distribution, dispensing of CS or List I chemicals or has had the State authority RECOMMEND the suspension, denial, revocation of a DEA registration 4. has committed an act which would render the DEA registration inconsistent with public interest or 5. has been exlcuded from a medicaire/medicaid program
The first generic version of a branded drug is granted an exclusivity period. How long is this exclusivity period?
180 days
timeline for each of the acts
1906- Pure Food and Drug Act 1938-FDCA 1951 - Durham-Humphrey Amendment 1962 - Kefauver-Harris Amendment 1987 - Prescription Drug Marketing Act 1994 - Dietary Supplement Health and Education Act
Filing filled Rx in 2/3 ways
2. Pharmacists may also keep two files with all federally controlled substances in one, marking those prescriptions in Schedules III, IV, and V with a large red C, and the other containing noncontrolled substances.
For purposes of classifying a drug as an orphan drug, a rare disease or condition is defined as follows: a disease or condition that affects (a) fewer than ______ persons in the United States or (b) more than _____ persons in the United States provided that there is no reasonable expectation that the cost of developing and making the drug available will be recovered.
200,000
Third way to file
3. The third method of filing prescriptions includes three separate files. One file is for Schedule II; one file for Schedule III, IV, and V; and one file for noncontrolled substances.
Under federal law, the daily sales limit of ephedrine base, pseudoephedrine base, or phenylpropanolamine base is _____ grams per purchaser, regardless of the number of transactions.
3.6
The Combat Methamphetamine Epidemic Act of 2005 places limits on the sale of nonprescription drugs containing pseudoephedrine, ephedrine, and phenylpropanolamine. Which of the following limits is accurate?
3.6 g per day, with purchases limited to 9 g per 30 day period
you may sell not more than 240 cc (8 oz) of a controlled substance containing opium, nor more than 120 cc (4 oz) of any other controlled substance, nor more than 48 dosage units of a controlled substance containing opium, nor more than 24 dosage units of any other controlled substance in any given period of how many hours?
48
A maximum of how many times may a prescription for a schedule III or IV controlled substance be refilled within 6 months of the date on which the prescription was issued?
5
As the owner of a community pharmacy, you recently employed a staff pharmacist and granted the pharmacist a power of attorney to order controlled substances. In addition to physically signing the DEA order form for schedule II controlled substances, the staff pharmacist completed the steps necessary to obtain authority from the DEA to place electronic orders for all schedules of controlled substances. Today, this pharmacist resigned from your employment. The pharmacist's resignation must be communicated to the DEA Certification Authority within what period of time?
6 hours!! you need POA for signing off DEA 222 forms. Recognize that before electronic ordering of controlled substances was permitted, notifying the DEA if a pharmacist with a power of attorney resigned or was terminated was not necessary. The power of attorney was useless without physical access to DEA Form 222. But with electronic ordering of controlled substances, a DEA Form 222 is not needed, so notification must be provided if the pharmacist had obtained the authority from DEA to submit electronic orders. The applicable DEA regulation is 21 CFR 1311.45.
At least how many days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must the manufacturer or distributor of that supplement, or of the new dietary ingredient, submit to the FDA information, including any citations to published articles, on which basis the manufacturer or distributor has concluded that the dietary supplement can reasonably be expected to be safe?
75
How many total days supply of a CS II may a provider write for when issuing multiple prescriptions for a patient?
90 days!!
A pharmaceutical company that originally developed the drug wants to lengthen the expiration date based upon additional stability data. Which of the following must the company submit to the FDA?
A Supplemental New Drug Application. An easy way to remember this is to know that if the Same company that original drug is submitting the application, a Supplemental New Drug Application is required. On the other hand, if Another company is submitting an application, it must be an Abbreviated New Drug Application.
true statement
A drug or biological product shall be considered to represent a meaningful therapeutic benefit over existing therapies if the drug or biological product could represent an improvement in the treatment, diagnosis, or prevention of a disease, compared with marketed products adequately labeled for that use in the relevant pediatric population.
An "adulterated product" means...
A drug or device that has been packed under insanitary conditions, whereby it may have been contaminated with filth
According to the federal FDCA, Authorized generic drug is termed....
A listed drug that is marketed, sold, or distributed directly or indirectly to a retail class of trade under a different labeling, packaging, product code, labeler code trade name, or trade mark than the listed drug
Which is required to register with the FDA as a manufacturer per federal FDCA?
A mfr of generic products a mfr of brand name products a pharmacy compounding a product to supply a physician to use in dispensing Rx orders a pharmacy compounding non-steriles for distribution to other pharmacies
advertising
A pharmacist may advertise and promote compounding as a service, but he or she may not advertise or promote the compounding of any particular drug, class of drug, or type of drug.
Your pharmacy discovers a significant loss of Lortab (acetaminophen and hydrocodone). The pharmacy must notify the DEA
A pharmacy must report, in writing to the local DEA Diversion Field Office, a significant loss of a drug product within 1 business day of the discovery.
DEA Form 510 allows...
A pharmacy use to register as a chemical distributor, thereby allowing the pharmacy to engage in the wholesale distribution of bulk quantities of SLCPs (schedule listed chemical product)
A narcotic drug that contains a non-narcotic active medicinal ingredient and is a schedule V controlled substance is defined as any compound that does not have more than
A. 200 mg of codeine per 100 mL of product. B. 100 mg of dihydrocodeine per 100 mL of product. C. 100 mg of opium per 100 g of product. D. All of the above** ANSWER!**
Federal law requires an exact count of which of the following products when a pharmacy conducts a biennial inventory?
A. Number of phenobarbital 30 mg tablets in an open 1,000 count bottle B. Number of fentanyl patches C. Milliliters of promethazine with codeine in an open 474 mL bottle **E. A and B only** ANSWER
An electronic order for a controlled substance may not be filled if which of the following is true?
A. The required data fields are not completed. B. The order is not signed using a digital certificate issued by the DEA. C. The digital certificate used has expired or has been revoked prior to signature. D. The validation of the order shows that the order is invalid. E. All of the above**ANSWER**
A serious adverse drug experience can result in which of the following events?
ALL BELOW: A. Immediate risk of death from the experience B. Death C. Prolongation of an existing hospitalization D. Congenital anomaly
The DEA has extensive recordkeeping requirements. However, which of the following IS required by the DEA?
ALL Except D: A. A pharmacy must maintain all unexecuted official order forms (DEA Form 222). B. A pharmacy must maintain a record of all controlled substances dispensed. C. A pharmacy must maintain a logbook (or electronic equivalent) for all pseudoephedrine sold without a prescription. D. A pharmacy must maintain a copy of all pharmacists' licenses. (NOT REQUIRED) E. A pharmacy must maintain receipts and invoices for schedule IV controlled substances.
When can the facsimile of a prescription for a schedule II controlled substance serve as the original prescription?
ALL below: A. When the prescription is for a narcotic to be compounded for direct administration to a patient via injection B. When a patient is a resident of a long-term care facility C. When a patient is enrolled in a hospice care program
The FDA must develop and maintain an accessible, consolidated Web site. What must be on this Web site?
All below: A. Patient labeling and patient packaging inserts B. A link to a list of each drug for which a Medication Guide is required C. The most recent safety information and alerts issued by the FDA
The labeling for all over-the-counter drug products that are intended for systemic absorption, unless specifically exempted, shall contain a general warning under the heading "Warning" as follows: " ask a health professional before use." In addition to the written warning, a symbol that conveys the intent of the warning may be used in labeling. This labeling policy applies to all of the following drug types except
All below: A. drugs intended to benefit the fetus during pregnancy. B. drugs labeled exclusively for pediatric use. C. drugs intended to benefit a nursing infant.
You have received a shipment of zolpidem. You must keep an invoice or packing slip on which you record
All below: A. the date the drug was received. B. the dosage form of drug products received. C. the number of commercial containers ordered and received.
The term dietary supplement means a product (other than tobacco) intended to supplement the diet that bears or contains which of the following dietary ingredients?
Amino acid, herb or other botanical, mineral, vitamin, all of the above
A written prescription presented to a pharmacy to cover an oral prescription for a schedule II controlled substance issued in an emergency situation must have which of the following statements written on its face?
Authorization for Emergency Dispensing
The following may issue a Rx for CS II
Physician, PA working in federal prison, and a Vet registered with DEA
A physician writes a prescription for 100 tablets of hydromorphone 4 mg. She notes on the prescription that the patient is terminally ill. How long does the pharmacist have to dispense in partial quantities up to the 100 tablets ordered?
BECAUSE pt is terminally ill -- The pharmacist may partially fill the prescription for 60 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed).
A federal govt practitioner is exempt from registration with the DEA if his/her ___ is on the Rx
Branch of military, service ID number (if military), social security number (if public health service employee)
When requesting a drug sample, a prescriber must provide which of the following items?
C. The prescriber's actual signature not really other info is needed
In terms of Rx drug labeling regarding side effects statement, which toll-free number is required?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
A DATA waived practitioner is a practitioner who wishes to prescribe or dispense controlled substances in schedules III, IV, or V for addiction treatment. Which of the following organizations grants this waiver?
Center for Substance Abuse Treatment within the Substance Abuse and Mental Health Services Administration
"[A] pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user" is the definition of which of the following?
Central Fill Pharmacy
Retail Pharmacist receives an emergency oral prescription for a schedule II drug. After determining all the criteria have been met for an emergency, Pharmacist calls Central Fill Pharmacist to have the prescription filled. What is Central Fill Pharmacist's preferred course of action?
Central fill pharmacies are not authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.
FDCA provides 3 classes of medical devices
Class I - not subject to pre-market approval Class II - subject to performance standards Class III - life supporting or life-sustaining devices and require pre-market approval by FDA!
Which of the following federal agencies regulates the Poison Prevention Packaging Act?
Consumer Product Safety Commission
When a pharmacy orders CS II drugs using the DEA official triplicate order form, which copy (copies) of the form is (are) sent by the pharmacy to the supplier?
Copies 1 and 2! The pharmacy keeps copy 3.
A moisturizer that claims sun protection is which of the following?
Cosmetic/Drug Combination
Which of the following is an unofficial compendia not included in the Official Compendia in the federal FDCA?
D. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations official compendia include USP, homeopathic pharmacopeia of US, National Formualaru
Which of the following is the federal agency that certifies private practice physicians to prescribe schedule III, IV, or V narcotic controlled substances for detoxification and maintenance treatment of opioid dependency?
D. Substance Abuse and Mental Health Services Administration The Substance Abuse and Mental Health Services Administration (SAMHSA), not the DEA, certifies physicians to prescribe schedule III, IV, and V narcotic controlled substances for detoxification and maintenance treatment of opioid dependency. Prescriptions for the currently approved products Suboxone and Subutex for treatment of opioid dependency must include the physician's DEA number and the physician's "X" number signifying certification to treat opioid dependency. Also, only physicians may be approved to treat opioid dependency. Information about the medication-assisted treatment of opioid dependency is available on the SAMHSA Web site at www.dpt.samhsa.gov.
What is DEA Form 223?
DEA Form 223 is the DEA Certificate of Registration that must be displayed at the registrant's location.
Which DEA form is required is someone wants to open a pharmacy to apply for a DEA Certificate of Registration?
DEA Form 224 DEA Form 224 is the application form for a new DEA Certificate of Registration. DEA Form 224a is the renewal application form that DEA mails to registrants approximately 60 days before the expiration of a DEA Certificate of Registration. DEA Form 106 is used to report theft or loss of controlled substances. DEA Form 222 is used to order schedule II controlled substances. DEA Form 223 is the number of the DEA Certificate of Registration that is displayed at the registrant's location. The applicable DEA regulation is 21 CFR 1301.13.
Manufacturers/wholesalers/importers/exporters/researchers register with ....
DEA Form 225, and renew with 225a.
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances for maintenance and detoxification treatment must obtain a separate DEA registration as a narcotic treatment program. Which of the following forms is required for this registration?
DEA Form 363
biennial inventory
DEA requires exact counting of medications listed in Scheduled II. III, IV, V may be estimated provided original package size was <1000 solid, dosage units. If the original package size is 1000, dosage units or greater, an exact count must be made.
A unit of a drug that is not intended to be sold and is intended to promote the sale of the drug is referred to as which of the following terms?
Drug sample
Patient did not receive the required Medication Guide that had been approved by the FDA for the drug prescribed and dispensed. Who is responsible for providing Patient with the Medication Guide?
Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this part shall, when the product is dispensed to a patient (or to a patient's agent), provide a Medication Guide directly to each patient (or to the patient's agent) unless an exemption applies under § 208.26.
Mail order of SLCPs
Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under §1310.03(c) of this chapter to submit a report of the sales transaction to the Administration may not in any 30-day period sell to an individual purchaser more than 7.5 grams of ephedrine base, 7.5 grams of pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in scheduled listed chemical products."
A scheduled listed chemical product (SLCP) is a product that may be marketed and distributed lawfully in the United States as a nonprescription drug. Which of the following drugs is included in the list of SLCPs?
Ephedrine and Phenylpropanolamine
A physician assistant who practices in a facility owned by an Indian tribe can use his social security number to write prescriptions for controlled substances at a local emergency room where he moonlights in lieu of obtaining DEA registration.
FALSE. The requirement of DEA registration is waived only when prescribing in the course of duty as a federal employee. The applicable section of the DEA Pharmacist's Manual is Section IX.
You receive a facsimile prescription from a practitioner authorizing refills for phenobarbital. The facsimile has no signature but has been marked "OK" by the receptionist. You can legally dispense from this facsimile
Facsimiles of prescriptions for controlled substances must be manually signed by the prescriber
the term "drug" in Official/recognized compendia per federal FDCA
Homeopathic Pharmacopeia of the US National Formulary US Pharmacopeia Any supplement to any of the official Compendia
A system is required for storage/retrieval of Rx processing systems -- it can supply immediate retrieval of information by either cathod ray tube (CRT) display or hard copy printout for Rx currently being filled.
Information must include: 1. date of issue 2. original Rx No. 3. Name/address of pt 4. Physician's name and DEA number 5. Name, strength, dosage form, and qty of CS 6. total number of refills
Drugs > Schedule II
Ketamine, amobarbital, dronabinol, testosterone
Which of the following items is required to be on a pharmacy's biennial inventory of controlled substances?
Mainly time and date of inventory!! No signature from person conducting inventory necessary
term "very low sodium" used in labeling OTC drug products for oral ingestion
Max daily dose: 35 mg
The FDA regulations regarding medication guides provide that where a medication guide is required for a particular prescription drug product, the medication guide must be provided to the patient on the initial dispensing of the drug but not on any refills thereafter
Medication guides must be provided on each dispensing
If a Patient Package Insert is not included in the labeling of a designated potentially dangerous drug, under federal law the drug is said to be:
Misbranded
If a drug and its container are so made, formed, or filled as to be misleading, that drug shall be deemed to be
Misbranded!
According to the Ryan Haight Act of 2008, online pharmacies are required to report their dispensing of controlled substances to the DEA. How often are those reports required?
Monthly
Pharmacists can execute a DEA Form 222, but they do not have to be registrants.
Moreover, there is no requirement that the person granted power of attorney be a health care practitioner. A pharmacy can grant power of attorney to any individual, whether or not the individual is located at the registered location.
Schedule V preparations
Not more than 200 mg of codeine per 100 mL or 100 g products containing codeine: diphenoxylate with atropine, cough/cold preparations such as Robitussin A-C, Phenergan VC, etc.
The DEA has multiple numbered forms. Which of the following forms would be used to register as a new pharmacist?
Pharmacies are registered with the DEA; individual pharmacists are not. Therefore, no form is required
Pharmacist needs to order a number of different medications, including controlled substances listed in Schedules II, III, IV, and V, as well as noncontrolled substances. Please choose the most accurate statement that reflects Pharmacist's options.
Pharmacist may order all needed medications using the electronic controlled substance ordering system. An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.
The U.S. Food, Drug, and Cosmetic Act at 21 U.S.C. 331 prohibits "alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded." However, 21 U.S.C. 353 of the act exempts from the labeling requirements the dispensing of a prescription drug as long as the label contains the information required
Pharmacists may remove the labeling of a "commercial" or "stock" container of a prescription drug, without violating the federal Food, Drug, and Cosmetic Act prohibition against removing the labeling of a prescription drug, when selling the drug on the prescription of a licensed prescriber.
While taking inventory, Pharmacist clears out expired stock, including a large number of controlled substances. What is Pharmacist's preferred course of action?
Request authorization and instructions from the DEA on how to dispose of the expired stock using DEA Form 41. (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area.
Using the Controlled Substance Ordering System, how is the DEA copied?
Supplier must forward either a copy of the electronic order or an electronic report (in DEA format) of the order to the DEA within two business days.
In addition to obtaining a separate DEA registration as a narcotic treatment program (using DEA Form 363), opioid addiction treatment programs must also be approved and certified by
The Center of Substance Abuse Treatment
true statement
The DEA will allow a retail pharmacy to register at the site of a long-term care facility and store controlled substances in an automated dispensing system in that facility.
Under HIPAA, a pharmacist must provide a patient with the "Notice of Privacy Practices" at what point in time?
The day the pharmacy first provides service to the patient. Specific requirements for certain covered health care providers. A covered health care provider that has a direct treatment relationship with an individual must:(i) Provide the notice:(A) No later than the date of the first service delivery, including service delivered electronically, to such individual after the compliance date for the covered health care provider; or(B) In an emergency treatment situation, as soon as reasonably practicable after the emergency treatment situation.
Registration for a DEA number is based upon which of the following?
The independent activity or activities engaged in by the registrant Any person who engages in more than one group of independent activities must obtain a separate registration for each group of activities. A person registered to engage in a controlled substance activity is authorized to engage in the coincident activities without obtaining a registration to engage in those coincident activities.
A patient has a prescription for 20 tablets of alprazolam 1 mg, 1 tid prn for anxiety, with 5 refills. She wants to pick up 10 tablets every week. Which of the following statements is correct?
The patient will receive 10 tablets a week up to the 120 tablets originally prescribed if no dispensing occurs beyond 6 months from the date on which the prescription was issued.
Pharmacist did not include the name of the prescriber on 20 prescription labels for controlled substances. The omission was negligent. What is the maximum penalty that may be imposed on Pharmacist for this violation under § 842 of the Controlled Substance Act?
The penalty for negligently keeping records is $10,000. If the violation had been with knowledge or intent (i.e., voluntary or deliberate) the penalty is criminal with a penalty of up to one year in prison and a fine of up to $25,000 or both. These penalties are for first offenses. Subsequent offenses could get higher penalties.
A physician in a same-day surgery center wants to have morphine on hand in her office. How may she get that morphine from your pharmacy?
The person or entity ordering the morphine is the person or entity that must fill out DEA Form 222. It is not acceptable for the pharmacy to use its own DEA Form 222 to complete the transaction. The pharmacy must complete the information as the supplier on DEA Form 222, but the pharmacy may not initiate the paperwork.
What constitutes appropriate action for a pharmacist when an uncooperative patient refuses to provide information for his patient prescription profile?
The pharmacist may fill the prescription without a medication history but should note patient's refusal in the record
A pharmacy sent several expired vials of meperidine to a registered reverse distributor for destruction -- what forms are involved?
The reverse distributor issued DEA form 222 (official order form) and DEA form 41 (Registrants Inventory of Drugs Surrendered). The pharmacy does not issue a form!
true statement
The statement is false. Please note that no drug product is truly child-proof; at best, a drug product is child-resistant. Packages that do not meet child-resistant standards must bear a conspicuous label stating, "This package for households without young children."
What is the federal expiration date for a prescription written for Ritalin (methylphenidate) 10 mg?
There is no federal time limit.
Durham-Humphrey Amendment to the FDCA
This created distinction b/w legend and non-legend drug by exempting certain drugs (legend drugs) from the "adequate directions for use" labeling requirement. After the amendment, legend drugs could be sold only by a pharmacy or other authorized dispenser pursuant to a prescription and could be dispensed in a container with a label that included directions for use. The amendment required a commercial container of a legend drug to carry on the label the statement "Caution: Federal law prohibits dispensing without a Rx" this language was known as "federal legend" and this is the reason Rx drugs also rferred as legend drugs. In 1997, the "Food and Drug Administration Modernization Act" replaced the statement with "Rx only"
A medical device, classified as a humanitarian use device, may be granted an exemption from proving effectiveness if the device is designed to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States
True
A pharmacy may place an emergency drug kit with controlled substances in a non-DEA registered long-term care facility if the appropriate state agency or regulatory authority specifically approves the placement and has procedures and rules to govern safe use.
True
Before a manufacturer of prescription drugs may distribute (either through its representatives directly or through an authorized distributor of record) prescription drug samples to any person allowed to receive samples under federal law, a written request must be submitted to the manufacturer by the person requesting the samples.
True
The U.S. Food, Drug, and Cosmetic Act allows a physician to use an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations, provided that the physician determines both that the patient has no comparable or satisfactory alternative therapy available and that the probable risk from the investigational drug is not greater than the probable risk from the disease or condition.
True
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 addresses which of the following issues?
Unlawful dispensation of controlled substances over the Internet
Pharmacist catches Pharmacy Tech in the act of stealing from bulk containers of controlled substances. Of the following, what is Pharmacist required to do under the federal Controlled Substance Act?
With DEA form 106, the registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.
You work for a chain of pharmacies that can access a real time, online database. How many times may you transfer a prescription for a schedule III pain medication within the chain?
You may transfer a prescription for a controlled substance up to the maximum refills permitted by law and by the prescriber's authorization.
As required by the Combat Methamphetamine Epidemic Act of 2005, pharmacies that sell over-the-counter products containing pseudoephedrine must
be self-certified with the DEA.
Pharmacist receives a prescription for 50 tablets of a schedule II drug. After checking her inventory, Pharmacist sees that she has only 30 tablets of the prescribed drug. She is expecting a shipment the next day that will restock her supply of this drug. What is Pharmacist's preferred course of action? Choose the best answer.
With Patient's permission, partially fill the prescription and tell Patient to return within 72 hours for the unfilled portion of the prescription. 21 CFR § 1306.13. Partial filling of prescriptions. (a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling. However, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
Pharmacies exempt from registration with the FDA as a manufacturer
a pharmacy compounding a product pursuant to a lawful Rx order A pharmacy compounding "in the regular course of their business of dispensing/selling drugs or devices at retail" the DQSA also exempts compounded drugs from new drug requirements, labeling requirements, and track-and-trace requirements if the drug is compounded by or under direct supervision of a licensed RPh in a registered outsourcing facility
A quality control manager at Widget Pharmaceuticals has just discovered that the manufacturing process has failed to follow Good Manufacturing Practices. A batch sample of a Widget Pharmaceuticals' intravenous solution has tested pure. If, in fact, the intravenous solution is pure, the solution would be
adulteratd
Which of the following requirements could be an element of an REMS to assure safe use?
all below: A. A requirement for patient monitoring B. A requirement for patients to enroll in a registry C. A requirement limiting the drug's use to certain facilities
A disciplinary action by the DEA against a registrant is initiated by which of the following?
an order to show cause
On the over-the-counter label for Benadryl (diphenhydramine), what would be listed under the heading "Purpose"?
antihistamine
DEA form 224
application for registration
DEA for 222
applies to schedule I and II drugs.
According to federal law, what information is required on the label for a controlled substance prescription?
date of filling and name of pt NOT number of dispensing pharmacy
The Controlled Substance Act ensures that all controlled substance transactions take place within a closed system of distribution. Which of the following groups ARE registered as a part of this system?
distributors, manufacturers, pharmacies, physicians
A pharmacy registration must be renewed
every 3 years, but AK LAW IS EVERY 2 YEARS!
According to the federal FDCA, the term rare disease or condition means any disease or condition affecting
fewer than 200,000 people in the United States.
glass vs plastic containers for prescriptions
he CPSC in response to whether pharmacists may reuse prescription vials, "As a general rule, no. This prohibition is based on the wear associated with a plastic vial, which could compromise the package's effectiveness. Since such wear or undetected damage with a glass container is negligible, the CPSC staff has indicated that it would have no objection to the reuse of a glass container, provided a new closure is used. This same consideration would be given to any other package type that is not prone to wear." See CPSC, "Poison Prevention Packaging: A Guide for Healthcare Professionals," available at www.cpsc.gov/CPSCPUB/PUBS/384.pdf.
difference between DEA Form 41 and 106
he breakage or spillage of controlled substances does not constitute a "loss" of controlled substances and must be reported on DEA Form 41 (Registrants Inventory of Drugs Surrendered), not DEA Form 106 (Theft or Loss of Controlled Substances). DEA Form 41, for example, is used when accidentally breaking 3 ampules of Morphine Sulfate
A pharmacy that discontinues business completely or only regarding CS must return ....
its DEA certificate and unused official forms (DEA forms 222) to local DEA registration Specialist.
What is the term applied to all written, printed, or graphic matter accompanying any drug article?
labeling
All information (i.e., Physician's DEA #, pt address, pt name) must be placed on actual prescription for a CS by either CSA or DEA except record of refills -- to be maintained in Rx's files!
may be maintained in electronic database used for the Rx dispensing rather than having to be placed on actual Rx form maintained in the pharmacy's Rx files.
According to federal law, pharmacies have two options for filing prescription records. Which of the following prescriptions would be filed separately from the others, in both systems?
meperidine
System documenting refills is needed either by CRT or hardcopy
must been kept for ALL CS that have been filled for past 6 months.. Pharmacies must printout hard copy or receive hardcopy from central processor within 72 hours of dispensing. Pharmacists who dispense these Rx must verify information on hardcopy is correct and then sign and date printout. A hardcopy printout or other documentation must be stored in a separate file for a period of 2 years!!
An initial inventory involving CS must contain...
name, address, DEA number of registrant, date/time of inventory, signature taking the inventory, name of medication, dosage form, dosage, and qty at hand... the once every 2 years, a BIENNIAL inventory must be taken of ALL federally CS substances
Scheduled listed chemical products - sales recorded in logbook -- who has access to this?
person facilitating a product recall
According to te FDCA, wich of the following may possess drug samples from either mfr or authorized distributor?
pharmacies in a hospital or health care entity, at the written request of a licensed practitioner osteopathic doctors dentists physician assistants
According to FDCA, the following MAY legally receive and possess prescription drug samples from mfr or authorized distributor
pharmacies located within a hospital/HC entity, at the written request of a licensed practitioner, osteopathic doctors, dentists, physician assistants
Tuberculosis, malaria, fascioliasis, leprosy, and yaws are
tropical diseases
A podiatrist wants to write one prescription for pain medication to be dispensed today and a second prescription for the same drug to be dispensed in 2 weeks. He should write today's date on the first prescription and a date 2 weeks from now on the second prescription.
prescription for a controlled substance must be dated and signed on the date when issued.
DEA form 222
purchase or transfer of CS II
CS II inventory
records and process must be separate from all other CS. ALL records are kept at the inventory location for 2 years.
Miscounts or adjustments to inventory involving clerical errors should be noted on ....
separate log at the pharmacy manager's discretion... NOT a DEA form
A package having one or more indicators/barriers to entry that, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred is which of the following?
tamper-evident packaging
You have just completed your biennial inventory of controlled substances. According to federal law, you must submit a copy of the inventory
to no one; there is no requirement to submit a copy of the inventory to the DEA
You agree to accept an oral emergency prescription for a schedule II controlled substance. According to federal law, the maximum quantity of the schedule II controlled substance that the practitioner may prescribe is a quantity sufficient
to treat the emergency period.
An online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based on a medical relationship with a prescribing practitioner, including at least one prior in-person medical evaluation.
true
To avoid having to register as a distributor under the CSA, the total number of dosage units distributed by Pharmacy may not exceed 5 percent of the total units of controlled substances distributed and dispensed in a calendar year. 50,000 is 5 percent of 1,000,000. This also assumes that all other requirements have been met.
true
You manage a pharmaceutical warehouse where schedule II controlled substances are sold to pharmacies. You receive a DEA Form 222 from a pharmacy ordering 10 bottles of 100 count oxycodone/acetaminophen 5/325 mg. It is acceptable for you to send 1 bottle of 1,000 count of the same drug and strength.
true statement
DEA form 41
used for inventory of drugs submitted
DEA Form 106
used for theft or loss of CS