KCorrect Answer as MPJE, KCORRECT ANSWER AS - Pharmacy Law Practice Exam Questions (2023), 3P Law Final Updated July 2023 Guaranteed Success -Dolophine 10mg tablets -Codeine sulfate 30mg tablets -Dilaudid 2mg/ml inj.-Exalgo 12mg tablets -Actiq 200mcg buccal -Methadone 5mg tablets - Correct Answer Dolittle Pharmacy needs to order the following medications from their drug wholesaler. Which of the below drugs must be ordered from the wholesaler using a DEA-222 form?-Diazepam 10mg tablets -Dolophine 10mg tablets -Codeine sulfate 30mg tablets -Fioricet tablets -Fiorinal tablets -Dilaudid 2mg/ml inj.-Lomotil liquid 2.5mg/5ml -Exalgo 12mg tablets -ButrCorrect Answer 7.5 mcg/hr trCorrect Answer dermal -Actiq 200mcg buccal -Methadone 5mg tablets -Acetaminophen with codeine solution
-Dolophine 10mg tablets -Codeine sulfate 30mg tablets -Dilaudid 2mg/ml inj.-Exalgo 12mg tablets -Actiq 200mcg buccal -Methadone 5mg tablets - Correct Answer Dolittle Pharmacy needs to order the following medications from their drug wholesaler. Which of the below drugs must be ordered from the wholesaler using a DEA-222 form?-Diazepam 10mg tablets -Dolophine 10mg tablets -Codeine sulfate 30mg tablets -Fioricet tablets -Fiorinal tablets -Dilaudid 2mg/ml inj.-Lomotil liquid 2.5mg/5ml -Exalgo 12mg tablets -ButrCorrect Answer 7.5 mcg/hr trCorrect Answer dermal -Actiq 200mcg buccal -Methadone 5mg tablets 1 / 4
-Acetaminophen with codeine solution
"Adequate directions for use" - Correct Answer Labeling requirements for OTC Drugs
"Adequate information for use" - Correct Answer Labeling requirements for Rx Drugs
(A) The name and address of the patient for whom the medication is intended; (B) the prescriber's name, the original date the prescription is dispensed and the number or designation identifying the prescription; (C) the name, strength and quantity of the drug dispensed and the name of the dispensing pharmacist; and
(D) drug allergies and sensitivities. - Correct Answer KCorrect Answer as:
Requirements for community pharmacy medication profile record
> Aka the Prescription Drug Amendment > Established 2 classes of drugs, prescription and OTC > Labels of prescription drugs need not contain "adequate directions for use" so long as they contained the legend, "Caution: Federal law prohibits dispensing without a prescription." > Authorizes oral prescriptions and refills of prescription drugs - Correct Answer Durham-Humphrey Amendment of 1951
> Aka Waxman-Hatch Amendment > ANDA process initiated > Patent extensions, in certain cases to innovator drugs > Intent: make generic drugs more readily available to the public and, at the same time, provide incentives for manufacturers to develop new drugs - Correct Answer Drug Price Competition and Patent Term Restoration Act of 1984
> Authorized the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies > Also imposes severe civil penalties for any false statements, bribes, failures to disclose material facts, and other related offenses - Correct Answer The Generic Drug Enforcement Act of 1992
> Blocks re-importation of exported US drugs > BCorrect Answer the sale, purchase, or trade of drug samples > Prohibits hospitals and other health care entities from reselling their drug purchases to other businesses (exceptions) > Requires the state licensing of drug wholesalers - Correct Answer Prescription Drug Marketing Act of 1987
> Defined dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA > Forced the FDA to regulate dietary supplements more as foods than as drugs - Correct Answer Dietary Supplement Health and Education Act of 1994 (DSHEA) 2 / 4
> Expedited availability of safe and effective drugs and devices > Changed "legend" to "Rx only" > Fast-track approval process for serious or life-threatening diseases > Expands the rights of manufacturers to disseminate unlabeled use information > Expands the FDA's authority of OTC drugs and establishes ingredient-labeling requirements for inactive ingredients - Correct Answer Food and Drug Administration Modernization Act of 1997 (FDAMA)
> Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations> - Correct Answer Nutrition Labeling and Education Act of 1990
> No new drug, cosmetic, or device could be marketed until proven safe > Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs. - Correct Answer Food, Drug, and Cosmetic Act of 1938
(FDCA)
> Provided for more extensive regulation and administrative authority regarding the
safety and efficacy of medical devices by requiring:
- Classification of devices according to their function
- Premarket approval
- Establishment of performance standards
- Conformance with GMP regulations
- Adherence to record and reporting requirements - Correct Answer Medical Device
Amendments of 1976 (MDA)
> Required that drugs be proved not only safe, but also effective > Established Good Manufacturing Practices (GMP) requirements > Required informed consent of research subjects and reporting of adverse drug reactions > Retroactive to all drugs marketed b/w 1938 and 1962 - Correct Answer Kefauver- Harris Amendment of 1962
> Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies > The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA reviews - Correct Answer Prescription Drug User Fee Act of 1992 (PDUFA)
>3.6g of base per purchaser per day >9g per purchaser per 30 days >7.5g per purchaser per 30 days if over mail order - Correct Answer Combat Meth...Act of 2005 - Sales Limits
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>All the normal stuff, plus date it was delivered to the retail pharmacy and method of
how it was delivered - Correct Answer Central Fill - Filling Site : C-II Rx
>Allows the FDA broader use of the fees generated from PDUFA, while substantially increasing the fees >Provides the FDA with significantly enhanced responsibilities and authority to regulate
drug safety, including to:
- Mandate labeling changes related to safety
- Require clinical trial data reporting and registries
- Require post-market (phase 4) clinical studies to assess risks
- Require companies to implement risk evaluation and mitigation strategies (REMS)
when necessary - Correct Answer Food and Drug Administration Amendments Act of
2007 (FDAAA)
>At least 14 days prior
>Return unused 222 Forms - Correct Answer DEA : TrCorrect Answer ferring
Pharmacy Time Frame
>C-II : only for narcotic parentral pain, pt in LTCF, pt in a Medicare certified hospice care - Correct Answer Faxed orders for Controlled Substances
>C-III : Not > 1.8g per 100ml or 90mg per dosage unit with at least 1 other non narcotic drug >C-V : Not > 200mg or any salts per 100ml or 100g - Correct Answer Codeine Scheduling
>Called MedWatch (drugs) & VAERS (vaccines) >Mandatory for Industry >Voluntary for Practitioners, Lay Public - Correct Answer FDA Post Marketing Surveillance
>Can be endorsed to another supplier, but must send all drugs to that new supplier - Correct Answer DEA-222 Form - What if Supplier can't supply Drug?
>Class 1 : Serious adverse health/death
>Class 2 : temporary or reversible
>Class 3 : adverse health not likely - Correct Answer Classes of Drug Recalls
>Community Pharmacy - buy with tax 190 proof alcohol from wholesalers for compounding >Hospital Pharmacy - buy tax free, compounding for inpatients only, not sold or distributed off premises - Correct Answer Alcohol Federal Regulations
>Copy 1 - Suppliers (brown) >Copy 2 - DEA (green) >Copy 3 - Purchaser (blue) - Correct Answer DEA-222 Form - 3 Copies go to whom?
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