Pop Law Exam 2012

Paper prescriptions for Schedule-II medications must be kept at the pharmacy to ensure accurate record-keeping and accountability. This requirement helps in preventing prescription fraud and abuse. It also allows for easy access to prescription information in case of any legal or regulatory inquiries. By keeping paper prescriptions on file, pharmacies can maintain a comprehensive record of all Schedule-II medications dispensed, ensuring the safety and well-being of patients.

Presciptions must be dated for the date on which they are written, but can include the date on which the fill is allowed

Though in my notes, the 1,000 quantity thing wasn't very clear

DEA registration is a requirement for the pharmacy, not the individual pharmacist. The Drug Enforcement Administration (DEA) registration is necessary for pharmacies to legally handle and dispense controlled substances. It ensures that the pharmacy follows all regulations and protocols related to controlled substances. While individual pharmacists may also have their own licenses and certifications, DEA registration is specifically tied to the pharmacy itself. Therefore, the statement that DEA registration is required for the pharmacy, not the pharmacist, is true.

As FYI, this refers mainly to those dispensing systems in nursing homes

All of the statements mentioned about hospital DEA permits are true. Hospital DEA permits can cover Hospitalists (physicians) in the scope of their employment. The permits include a practitioner/internal code number as a suffix to the DEA number. Additionally, the hospital is required to have a list of codes available upon request by law enforcement agencies.

Compassionate Use INDA- way to get a drug that is still in clinical trials for patients that have no other treatment for their conditions, experimental treatment

The given answer is correct because a "New Drug" can refer to a drug that is being used in a different patient population than originally approved, administered in a different form, or used for a different indication. In other words, any of these conditions would make a drug qualify as a "New Drug."

A "commerical container" is what is received from the manufacturer

In the case of a significant loss, theft, or robbery, the form that must be filled out is Form 106. This form is likely a standardized document used to report such incidents and gather relevant information for further investigation or insurance purposes. The other options listed, Form 222, Incidence Reporting Form 3A, and TPS Report (with cover sheet), do not specifically pertain to reporting loss, theft, or robbery incidents.

Abbreviated New Drug Applications must prove bioequivalence of generic to brand

Label - display of written or printographic matter on the vial
Labeling - display of written or printographic matter on the vial + package insert

(I don't think it may be a direct quote, but something to the order of) Pharmacist - “any pharmacist licensed by a State to dispense controlled substances, and shall include any other person authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.”

Schedule 2 prescriptions can be communicated orally in emergency situations. This means that in urgent cases where immediate access to the medication is necessary, healthcare professionals can verbally communicate the prescription to the pharmacist, rather than providing a written prescription. This allows for quicker access to medication in emergency situations, ensuring that patients receive the necessary treatment promptly.

In an emergency situation, the pharmacist is not required to fill out a prescription and Form 106.

All anabolic steroids are under Schedule 3

Stimulant for Diet Supression

The explanation for the given correct answer is that the FDA is responsible for overseeing and regulating all advertising related to prescription drugs, while the FTC is responsible for controlling the advertising of over-the-counter drugs and dietary supplements. This means that the FDA has authority over the advertising of drugs that require a prescription, while the FTC has authority over the advertising of drugs that can be purchased without a prescription and dietary supplements. Therefore, the statement that the FDA controls advertising regarding prescription drugs and the FTC controls advertising of OTC and dietary supplements is true.

Form 222 is a special procedure for filling certain orders. The statement that is FALSE regarding Form 222 is that mistakes require single strike through NOT "blacking out" of information. This means that if a mistake is made on Form 222, it should be corrected by using a single strike through, rather than blacking out the incorrect information. This ensures that the original information is still visible and the correction is clear.

Add 1st + 3rd + 5th digits = TOTAL (9)
Add 2nd+ 4th + 6th digits and multiply (*) by 2 = TOTAL (24)
Add two totals → last digit of sum should be 7th digit of DEA number (33; 7th digit should = 3)

A DEA permit can be renewed within 60 days of expiry. This means that individuals or entities holding a DEA permit have a 60-day window after their permit expires to apply for its renewal. It is important to renew the permit within this timeframe to ensure that there is no lapse in authorization to handle controlled substances.

A maintenance treatment can go on forever

The correct answer is 5%. This means that the maximum percentage of distributed drugs that can be Controlled Substances is 5%. This suggests that there are regulations or guidelines in place to limit the distribution of Controlled Substances to ensure their proper use and prevent abuse or misuse.

When it comes to moves or name changes, new permits must be obtained before the change actually takes place. This implies that the necessary permits and paperwork should be completed prior to the move or name change occurring. Therefore, the statement "New permits as a result of moves/name changes must be done before the change takes place" is true.

The correct answer is "All of the above are valid reasons." This means that all of the reasons listed (Medicare fraud, violation of controlled substances act, death, closure of a pharmacy) can lead to the termination of registration, except for the option "All of the above."

A person with no felony conviction but a history of successful rehabilitation for chemical dependency can be hired by a pharmacy because they have demonstrated the ability to overcome their addiction and have not been involved in any serious criminal activity. This shows that they have taken the necessary steps to address their past issues and can be trusted to handle the responsibilities of working in a pharmacy.

Central records must be able to reach a pharmacy location within 2 days. This ensures that the necessary records and reports of registrants are readily available for the pharmacy's operations and compliance purposes. A shorter timeframe would be too restrictive, while a longer timeframe could potentially hinder the pharmacy's ability to access important information in a timely manner.

Form 222's must be kept at pharmacy (retail locations) for 2 years

When a medication is newly scheduled or moved to a new schedule, the manufacturer must have proper marking in place before any prescription for that medication can be filled. This ensures that the medication is properly labeled and packaged as a controlled substance, and helps to prevent any errors or confusion in dispensing the medication. Therefore, the statement "True" is correct.

Delivery personnel are not included in the "closed system" of controlled substances. The closed system refers to the strict regulations and monitoring of the manufacturing, distribution, prescription, and dispensing of controlled substances. While manufacturers, distributors, prescribers, and dispensers are all part of this closed system and have specific responsibilities and regulations to follow, delivery personnel are not directly involved in the handling or administration of controlled substances. Their role is primarily focused on transportation and delivery of medications rather than the actual control and monitoring of these substances.

A DEA permit is valid for pharmacies for a period of 3 years. This means that once a pharmacy obtains a DEA permit, they are authorized to handle and dispense controlled substances for a duration of 3 years. After this period, the pharmacy will need to renew their permit to continue operating legally and handling controlled substances.

All of the file choices mentioned in the options are acceptable. There is no option that is not acceptable.

Manufacturers of of Schedule I and II must submit quota request to the DEA, which never rejects a quota request (due to methylphenidate issue)

Except in the 7 states with allow pharmacists to write for controlled substances (collaborative practice agreements)

Detoxification programs are considered long-term if they last for a period of 30 days to 6 months. This means that any program that lasts less than 30 days is considered short-term.

physicians, dentists, veterinarians, podiatrists

The DEA does consider "telemedicine" to be a practice of medicine....I actually don't know if insurance companies do or not

A prescription can be transferred no more times than refills allotted (i.e. 3 refills = 3 refills MAX). This statement is false because a prescription can only be transferred once, regardless of the number of refills allotted. Once a prescription is transferred, it becomes void at the original pharmacy and can no longer be refilled or transferred again.

Pregabalin (Lyrica) is classified under Schedule V. Schedule V drugs have a lower potential for abuse compared to drugs in Schedules II-IV. They are considered to have a currently accepted medical use and may have limited physical or psychological dependence when compared to drugs in higher schedules.

The correct answer is "Safe Harbor Provision." A pharmacist's "freedom of fault" refers to the protection they have from legal liability when they rely on the written guarantee provided by manufacturers that the drugs purchased are not adulterated or misbranded. The Safe Harbor Provision offers this protection to pharmacists, allowing them to trust the guarantee and distribute the drugs without fear of being held responsible if any issues arise.

This statement is true because according to the given information, only a registered retail pharmacy is allowed to install and operate an automated dispensing system at a long term care facility. This implies that no other person or entity is authorized to perform this task. Therefore, the correct answer is true.

"Original Four" described in Federal Control Substances Act- physicians, dentists, veterinarians, podiatrists. States can add mid-level practitioners (e.g. collaborative practice)

The statement is true because the phrase "at least bi-annually" means that inventory must be taken at least twice a year. This ensures that the inventory is regularly checked and updated, allowing the company to have an accurate record of its stock levels. By conducting inventory at least bi-annually, the company can identify any discrepancies, such as missing or excess items, and take appropriate actions to maintain an efficient inventory management system.

Executive branch → Justice department (attorney general) → FBI → DEA

Form 222 (executive order forms), Manufacturer invoices, Paper prescription must be kept

A Schedule II prescription can be transmitted electronically between a retail pharmacy and a central as long as it says "Central Fill" on the prescription. This means that if a prescription for a Schedule II drug includes the designation "Central Fill," it can be sent electronically from a retail pharmacy to a central location for filling. This allows for more efficient and streamlined processing of prescriptions, ensuring that patients receive their medications in a timely manner.

Assisted living facilities don't really provide medical care (as I understand). They are more like "hotels".

Compounder means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

Category 7 registration is for Narcotic Treatment Programs

The maximum amount of units that can be brought in is 50 TOTAL. Meaning 50 unites of Med A, OR 25 units of MedA + 25 units of Med B

The given statement is true because dietary supplements are indeed drugs that are taken orally. They are intended to supplement the diet and provide additional nutrients or substances that may be lacking in a person's regular diet. Dietary supplements can come in various forms such as pills, capsules, powders, or liquids, and they are designed to be taken by mouth. Therefore, the statement accurately describes the route of administration for dietary supplements.