Pharmacy Verification Guide

• This document is a verification guide for pharmacies, clinics, and hospitals, with the SAGARPA file number at the top.
• It includes fields for the Establishment Name, Fiscal Address, Establishment Address, and Storage Address.
• It contains a table to record compliance with various regulations.
• The table includes columns for:
  • Item Number
  • Regulatory Framework
  • Points to Verify
  • Compliance Status (Complies, Does Not Comply, Not Applicable)
  • Observations (for additional documents or evidence)

Document Review - General Information

• Verify the visited party's name, denomination, or corporate name.

• Verify the accuracy of the address (street, number, town or colony), phone number or other available means of communication, municipality or delegation, postal code, and state where the visit is conducted.

• Specify the company's line of business (activity) using points 1 or 2.

• Points 1 and 2 refer to:

  • Legal entity: Articles of incorporation (corporate purpose)
  • Natural person: Notarial power

• Documentation is checked against the SAGARPA authorization or acknowledgment of the authorization request. Request the layout plan of facilities and the employee and supply flow diagram.

• Confirm the existence of a notice or ruling of operation with the Secretariat.

• Confirm notifications of recent authorization modifications to the Secretariat.

• Confirm the medical vet responsible is authorized by the Department (determine the validity).

• Possess a provider, distributor, and customer relationship.

• Chemical-biological products sold or imported in the country are subject to animal health inspection and have a SAGARPA regulation number.

Products

• Possess a monthly sales record for Group I pharmaceuticals, using the format determined by the Ministry.
• Possess Group II pharmaceuticals.
• Possess a biannual verification report issued by a veterinarian certified by the Ministry as a third-party specialist.

Veterinary Pharmaceutical Specifics

• Only products with a SAGARPA regulation number that are labeled according to NOM-012-ZOO-1993 are marketed.
• Do not to market products for human use and medicinal samples.
• Do not market raw materials used in producing chemicals or pharmaceuticals.
• Do not market pure salts, restricted products, or human medical samples.
• Have refrigerators to store biological and chemical pharmaceuticals when required.
• Biological and chemical pharmaceuticals are delivered to the consumer with coolant when they need it.
• The food that bulk markets prevent deterioration or contamination in containers.
• Store pesticides and other harmful compounds are kept in distinct and restricted locations.

Sales Control

• Maintain a sales control book (incoming and outgoing) of products that contain active ingredients classified in Group I, along with a security system for safeguarding products in this group.
• Keep a private file for safeguarding medical prescriptions for products that include active ingredients classified in Group I in their formulation.
• Maintain a private file to keep medical prescriptions for products that have Group II active ingredients in their formulation.
• Packing materials (labels, boxes, and instructions) and commercial information derived from the regulation of products containing Group II active ingredients must bear the restriction legend "Their sale requires a medical prescription."
• Copies of medical prescriptions issued for the sale of veterinary pharmaceuticals containing active ingredients from groups I and II are available.
• The wording on the labels and bottles of products used in veterinary medicine must comply with NOM-012-ZOO-1993.
• Active ingredients classified as prohibited are not to be sold or stored.

Clinics and Veterinary Hospitals

• Keep copies of medical prescriptions generated by the sale of products with active ingredients from Groups I and II.
• The products with active ingredients of Group 1 support the legend "ITS SALE REQUIRES QUANTIFIED MEDICAL PRESCRIPTION" and "FOR EXCLUSIVE USE OF THE VETERINARY DOCTOR".
• The products with active ingredients of Group 2 support the legend "ITS SALE REQUIRES PRESCRIPTION“.
• A security system must be in place for safeguarding and tracking products containing active ingredients from Group I.
• The wording on the labels and bottles of products used in private practice must comply with NOM-012-ZOO-1993.
• There must be a Veterinary Doctor on staff.
• Verify not to use veterinary pharmaceutical products that include active ingredients classified as prohibited.
• Maintain a pest control program against insects and rodents.

Documentation

• The document also includes sections for:
  • Name and signature of the Verification Unit or Third Party Specialist personnel
  • Unit Seal of Verification
  • Approval or Authorization Code
  • Date
  • Time