Ley de Farmacia y Regulaciones en Puerto Rico: Examen de Sustancias Controladas y Farmacéutica | Quizlet

¿Cuál es la ley principal que regula la práctica de la farmacia en Puerto Rico?

Ley de Farmacia de Puerto Rico, Ley Núm. 247-2004, según enmendada.

¿Cuál es el propósito de la Ley Núm. 247-2004?

Regular el ejercicio de la profesión, incluyendo la fabricación, distribución y dispensación de medicamentos.

¿Cuáles son los requisitos para ejercer la farmacia en Puerto Rico?

Licencia, colegiación y recertificación.

¿Cuál es el requisito de edad mínima para obtener una licencia de farmacia en Puerto Rico?

21 años de edad.

¿Cuál es el número mínimo de horas requerido para la práctica de farmacia en Puerto Rico?

1,500 horas.

¿Qué se requiere para la recertificación de una licencia de farmacia en Puerto Rico?

35 créditos de EC cada 3 años y prueba de membresía activa en el Colegio de Farmacéuticos de Puerto Rico.

¿Cuál es la importancia del Reglamento del Ministerio de Salud Núm. 156?

Regula el funcionamiento de los establecimientos dedicados a la fabricación y distribución de medicamentos.

What does the resolution No. 2016-188 state about pharmacists?

Pharmacists with two years of experience are qualified to be preceptors.

What is the role of the Colegio de Farmacéuticos de Puerto Rico?

It is the legal body that regulates the practice of pharmacy in Puerto Rico.

What is required to obtain a pharmacy license regarding educational qualifications?

A degree in pharmacy from an accredited institution.

What does the recertification process involve for inactive pharmacists?

They must meet continuing education requirements for the inactive years and submit a recertification application.

What are the consequences of obtaining a pharmacy license through fraud?

Denial, suspension, cancellation, or revocation of the license.

What is the purpose of the Examen General in the pharmacy licensure process?

To assess the application of knowledge, judgment, and skills necessary for pharmacy practice.

What does the Examen de aspectos legales evaluate?

Knowledge of legal aspects of the pharmacy profession.

What is the legal basis for the requirement of collegiation in Puerto Rico?

Ley Núm. 243 de 15 de mayo de 1938.

What is the significance of the Reglamento de la Secretaria de Salud Núm. 8867?

It regulates the operation of establishments dedicated to the sale, distribution, and manufacture of veterinary products.

What does resolution No. 2016-260 authorize pharmacy interns to do?

Practice the administration of vaccines.

What is the requirement for a pharmacy intern regarding supervision?

Interns must complete their hours under the supervision of a preceptor pharmacist.

What happens if a pharmacist is convicted of a crime related to moral depravity?

They may face denial of their pharmacy license.

What is the process for appealing a recertification decision by the Junta de Farmacia?

Request an administrative hearing and potentially appeal to the competent court.

What is the purpose of the Orden Administrativa del Secretario de Salud Núm. 269?

To provide administrative guidance related to pharmacy practice.

What does the term 'recertificación' refer to in the pharmacy profession?

The process of renewing a pharmacy license every three years.

What is the consequence of being mentally incapacitated as declared by a court?

Denial of the pharmacy license.

What must be submitted to the Registro de Profesionales for recertification?

Evidence of continuing education units, certification from ASUME, and a criminal background certificate.

What is the significance of the Reglamento de la Secretaria de Salud Núm. 156A?

It regulates the exchange of biological products.

What is required for a pharmacy intern to start their internship?

Authorization from the Junta de Farmacia after completing the first year of pharmacy studies.

What can lead to the revocation of a pharmacy license in Puerto Rico?

Conviction for violation of the Controlled Substances Act or any crime involving moral turpitude related to pharmacy qualifications.

What mental condition can lead to the loss of a pharmacy license?

Being declared mentally incapacitated by a competent court.

What is a consequence of providing false testimony for a pharmacy license applicant?

It can result in the revocation of the pharmacy license.

What actions regarding documents can result in disciplinary action for pharmacists?

Altering or falsifying documents with malicious intent to deceive the board.

What is the responsibility of a pharmacist regarding unlicensed individuals?

Allowing or aiding someone to practice as a pharmacist knowing they lack a license.

What ethical standards must pharmacists comply with?

Laws and ethical canons regulating pharmacy practice and medication distribution.

What constitutes a manifest incompetence in pharmacy practice?

Demonstrating a pattern of incompetence that risks consumer health and safety.

What is required for a pharmacist's license to be reinstated after substance addiction?

Participation in a treatment program and proof of overcoming the condition.

What are the main functions of a pharmacist according to Law 247 of 2004?

Dispensing medications, providing medication guidance, participating in medication decisions, and supervising pharmacy technicians.

What is involved in the dispensing process by a pharmacist?

Receiving, evaluating, interpreting prescriptions, and preparing medications.

What must a pharmacist do before delivering medication to a patient?

Verify the prescription with the medication and the patient's pharmaceutical record.

What is the role of a pharmacist preceptor?

Supervising pharmacy interns and ensuring compliance with regulations.

What are the requirements for a pharmacy practice center?

Must be licensed and attended by an authorized pharmacist.

What is the role of a pharmacy inspector?

Inspecting and examining documentation and activities related to pharmacy licenses.

What can the board certify for pharmacists?

Specialist status in a pharmacy area with a recognized specialty certificate.

What are the penalties for practicing pharmacy without a license in Puerto Rico?

Up to six months of imprisonment or a fine not exceeding $5,000.

What is required for a pharmacist to administer vaccines?

Possession of a certification for vaccine administration.

What should a pharmacist do if a patient refuses medication orientation?

Document the patient's explicit refusal.

What is the responsibility of a regent pharmacist?

Ensuring compliance with pharmacy laws and regulations.

What is the significance of bioequivalent medications?

Pharmacists must offer patients the option to exchange for bioequivalent or biosimilar medications.

What is the maximum number of interns a pharmacist preceptor can supervise at once?

Two interns at the same time.

What is the consequence of dispensing medications without proper licensing?

It is considered a criminal offense under pharmacy law.

What must pharmacists ensure when preparing medications?

That the medication is properly labeled and packaged.

What is the role of the pharmacy board in Puerto Rico?

To regulate pharmacy practice and ensure compliance with laws.

What is the requirement for a pharmacist to supervise pharmacy technicians?

The pharmacist must be licensed and responsible for their actions.

What is the importance of confidentiality in patient orientation?

Patient information must be kept confidential during medication discussions.

What is the role of a pharmacist in collaborative medication management?

Participating in decision-making about medication use with patients and healthcare providers.

What must a licensed prescriber provide to a patient?

Any medication except medical samples in their original packaging identified by the manufacturer.

What is prohibited for physicians regarding patient referrals?

Referring patients to a pharmacy in which they have a financial interest.

What must a pharmacy possess to operate legally?

A license, certificate, or authorization as required by law.

What is the consequence of acting as a representative without a license?

It is illegal and subject to penalties under the law.

What is required for selling medications to establishments?

The establishments must have the appropriate license, certificate, or authorization.

What must accompany the sale of prescription medications?

A valid prescription issued by an authorized medical professional.

What type of advertising is prohibited for pharmacies?

Using terms like 'pharmacy' or 'drugstore' without a proper license.

What is the penalty for obstructing pharmacy inspectors?

It is a felony punishable by up to one year in prison.

What is the maximum suspension period for a professional license due to repeated offenses?

Up to sixty days.

What are the age requirements to become a Pharmacy Technician in Puerto Rico?

Must be at least 18 years old.

What is a requirement for obtaining a Pharmacy Technician certificate?

Completion of a pharmacy technician course from an accredited institution.

How many hours of supervised practice are required for Pharmacy Technicians?

A minimum of 1000 hours.

What is required for recertification of Pharmacy Technicians?

Completion of 20 hours of continuing education every three years.

What can lead to the denial of a Pharmacy Technician certificate?

Fraud, failure to meet requirements, or a recent felony conviction.

What is the role of a Pharmacy Technician under a pharmacist's supervision?

To assist with technical and administrative tasks that do not require professional judgment.

What functions are Pharmacy Technicians not allowed to perform?

Verifying prescriptions or counseling patients on prescribed medications.

What must be proven to have a Pharmacy Technician certificate reconsidered after denial?

Evidence of rehabilitation from substance abuse.

What does 'persona jurídica' refer to in the context of pharmacy law?

Legal entities such as associations, corporations, or societies.

What is the purpose of the Pharmacy Technician Certification Board (PTCB)?

To provide certification examinations for pharmacy technicians.

What happens if a pharmacy promotes services without a license?

It is considered illegal and subject to penalties.

What is the significance of Article 5.03 in the pharmacy law?

It outlines the provisions that health service plans must include regarding medications.

What are the legal implications for a Pharmacy Technician who administers vaccines without compliance?

They may face legal action for not adhering to established requirements.

What is the consequence of selling medications without a prescription?

It is illegal and can result in severe penalties.

What does the law say about the promotion of bioequivalent drugs?

It prohibits receiving incentives for promoting certain medications against medical quality standards.

What is required for a Pharmacy Technician to apply for revalidation?

Evidence of completing the required supervised practice hours.

What must a Pharmacy Technician do to maintain their certification?

Fulfill continuing education requirements and pay applicable fees.

What can lead to the suspension, cancellation, or revocation of a pharmacy certificate?

Obtaining the license through fraud, substance addiction, conviction of drug-related crimes, mental incapacity, false testimony, document falsification, allowing unlicensed practice, ethical violations, incompetence, or posing a public health risk.

What is required for a pharmacist or pharmacy technician to reinstate their license after substance addiction?

Participation in a treatment or rehabilitation program and proof of overcoming the condition.

Under which law does a pharmacy technician operate?

Law 247 of 2004.

What are the primary functions of a pharmacy technician?

To work under the direct supervision of a pharmacist and perform technical or administrative tasks that do not require professional judgment.

How many members are on the Pharmacy Board?

Seven members: six pharmacists and one pharmacy technician.

What are the qualifications for members of the Pharmacy Board?

Must be active in the profession for the last five years and cannot be affiliated with pharmacy education institutions.

What is the term length for members of the Pharmacy Board?

Four years, with no more than two consecutive terms.

What is the primary responsibility of the Pharmacy Board?

To safeguard public health and regulate the practice of pharmacy.

What powers does the Pharmacy Board have?

Authorize practice, deny or revoke licenses, conduct examinations, and maintain records of licenses.

What is required for a pharmacy to operate legally?

Obtain a license from the Secretary to acquire, sell, or dispense medications.

What are some requirements for a pharmacy license?

Security measures for medication handling, minimum equipment, procedures for document transfer, and having at least one pharmacist on duty.

What must a pharmacy have for patient consultation?

A confidential area for patient orientation.

What is the role of the pharmacist in a pharmacy?

To oversee the dispensing of medications and ensure compliance with regulations.

What constitutes a crime for pharmacy technicians?

Engaging in practices that violate pharmacy laws or ethical standards.

What can the Pharmacy Board do in response to complaints?

Investigate, summon witnesses, and take legal action if necessary.

What is the significance of the Pharmacy Board's ability to deny or revoke licenses?

It helps maintain professional standards and protects public health.

What is required for a pharmacy to change ownership?

Procedures for transferring medications and patient records must be followed.

What is the minimum requirement for a pharmacy's physical space?

A designated area for the dispensing of prescription medications.

What is the role of the Secretary in pharmacy licensing?

To issue licenses and ensure compliance with pharmacy laws.

What happens if a pharmacy technician allows unlicensed practice?

They may face disciplinary action from the Pharmacy Board.

What is the importance of ethical compliance in pharmacy practice?

It ensures the safety and well-being of patients and upholds professional integrity.