Pharmacy Verification Guide

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Questions and Answers

According to the verification guide for pharmacies, clinics, and hospitals, what is the primary purpose of checking the establishment's name, denomination, or company name?

  • To verify its compliance with local zoning laws.
  • To validate the legal identity of the entity being inspected. (correct)
  • To assess the establishment's marketing strategy and branding efforts.
  • To confirm the establishment's tax identification number for accounting purposes.

Why is it important for a pharmaceutical establishment to accurately specify their business activity (giro de la empresa) during a verification process?

  • To gather data on the overall economic impact of pharmaceutical companies.
  • To enable the government to send the establishment promotional newsletters.
  • To ascertain whether the establishment's operations align with its stated object social or authorization. (correct)
  • To determine if the establishment qualifies for specific tax exemptions.

According to the verification guide, What is the significance of checking the establishment's registered address (domicilio) during an inspection?

  • To evaluate the accessibility of the location for customers.
  • To assess the property value for tax purposes.
  • To analyze the demographic characteristics of the surrounding neighborhood.
  • To confirm that the physical location matches the official records and the scope of authorization. (correct)

Why is it essential for establishments to notify the Secretariat of modifications to their authorization?

<p>To maintain transparency and accountability regarding any changes in operations or compliance status. (B)</p> Signup and view all the answers

What is the main purpose of requiring pharmacies to maintain a record of its suppliers, distributors, and customers?

<p>To track the flow of products and ensure accountability in the supply chain. (A)</p> Signup and view all the answers

Why do regulations mandate verifying that chemical-biological products commercialized in the country have a SAGARPA regulation number?

<p>To verify that the products meet zoosanitary control standards and are safe for use. (C)</p> Signup and view all the answers

What action should an establishment take if they commercializes pharmaceutical products classified in Group I, according to the guidelines?

<p>Report the sale of such products to the Secretariat on a monthly basis. (A)</p> Signup and view all the answers

Why is it necessary for Veterinary pharmacies to have a biannual verification dictate issued by an authorized veterinarian?

<p>To ensure compliance with veterinary-specific regulations and maintain standards of practice. (C)</p> Signup and view all the answers

How does requiring Veterinary clinics and hospitals to maintain copies of medical prescriptions generated by the sale of products assists in adherence to regulations?

<p>It allows for auditing of prescribing practices and verification of appropriate medication use. (B)</p> Signup and view all the answers

What specific measure is identified in the content for establishments to control pests (such as insects and rodents)?

<p>Maintaining a program for control of pests. (A)</p> Signup and view all the answers

Flashcards

Name or company name

Name, denomination, or company name of the inspected entity.

Accurate address

Ensuring the address is accurately recorded for official records and follow-up.

Company's business activity

Verifying the company's designated business activity as stated in official documents.

Authorization modification

Ensuring awareness and compliance with the latest modifications in operations or structure.

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Authorized Veterinary

Verification that the establishment has a veterinarian responsible authorized by the secretariat.

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Relationship records

Checking there is a list of suppliers, distributors, and clients to ensure accountability and traceability.

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Regulated products

Ensure that products are properly regulated under SAGARPA guidelines.

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Pharmaceutical sales report

Confirming the monthly sales reporting of specific controlled pharmaceuticals.

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Verification of the veterinarian

Verification of a third-party veterinary medical verification every two years

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Pest control program

Ensure there is a pest control program in place to prevent contamination and health risks.

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Study Notes

General Information

  • Verification guide for pharmacies, clinics, and hospitals.
  • Requires the establishment's name and SAGARPA file number.
  • Requires addresses for the business, establishment, and storage area.
  • Requires to indicated verification location.

Document Review

  • Verifies the provided name and social reason of the business visited.
  • Checks correct address (street, number, town, neighborhood), phone number or communication method, municipality, zip code, and state where the visit is conducted.
  • Requires business line specification.
  • Specifies legal status through articles of incorporation for corporations or a notarized statement for individuals.
  • Requires matching records with SAGARPA authorization otherwise request for authorization needs to be provided

Facility and Operational Requirements

  • Asks for facility layout and personnel/supply flow chart.
  • Requires notice or official statement of operation to the Secretary.
  • Requires notifying the Secretary of recent authorization changes.
  • Veterinary doctors that have their license must be authorized by the Secretary.
  • Asks for list of suppliers, distributors, and customers.
  • Requires active ingredients under the control of animal epidemic products that are sold or imported and have a SAGARPA regulation number.

Pharmaceutical Products

  • Requires Group I pharmaceutical products to be classified, and such drugs will be reported through means that are determined by the Secretary by format. 
  • All pharmaceutical products in group II must be classified.
  • Requires biannual verification document by an authorized veterinary doctor.

Veterinary Pharmacies

  • Only products with SAGARPA regulation numbers are sold and are labeled following NOM-012-ZOO-1993.
  • Prohibits commercialization of human products and medical samples.
  • Prohibits ingredients in the fabrication of chemical or pharmaceutic product, and pure salts.
  • Requires proper storage of biological and chemical pharmaceutical in the refrigerators.
  • Biological and pharmaceutical products must be given cold to consumers.
  • Proper containment of food if sold loose in containers.
  • Area for toxic substances are stored in separated and secured areas. 
  • Requires to have sales to the products of group 1 with a logbook. 
  • Protected document of formulas of products that have ingredients of group 1 that must have confidentiality. 

Regulation and Labeling

  • Confidential file of medical that are generated from group II ingredients in products.
  • Packaging, boxes, and instructions show restriction that indicate restriction for selling with prescription in group II ingredients. 
  • Copied medical recipes for products with group 1 and 2 must have veterinaries
  • Labels and bottles must adjust according to NOM-012-ZOO-1993 of products.
  • Ingredients that are restricted cannot be stored. 

Veterinary Clinics and Hospitals

  • Requires medical recipes copies of ingredients of the products that have sales in group 1 and 2. 
  • Group 1 ingredients contain for selling by veterinarian and restriction medical recipe
  • Group 2 ingredients should be sold under medical recipe in the boxes and labels. 
  • Requires to be protected with system that locks and secures of the ingredients of group 1.
  • Labels and bottles must have printed recipes for private veterinarian practices that follow the prescription of NOM-012-ZOO-1993.
  • Verify with pharmaceuticals that they are prohibited from veterinary practices.
  • Doctor must be a veterinarian.

Miscellaneous

  • Has pest control program to stop insects.
  • All verification must be complete with name and signature of authorized personal and key of approval with date and time.

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