Regulation & Inspection

Defining the appropriate, country-specific mix of public- and private-sector responsibilities in a drug seller initiative is critical for timely scale up and sustainability: The private sector should assume more of the routine set-up and implementation functions, such as training and marketing, while government needs to focus on activities to protect public health, such as establishing regulations and standards for premises and personnel and providing enforcement through regular inspections. Another critical regulatory activity is determining which medicines the accredited shop will be allowed to sell.


Examples of Requirements to Become an Accredited Drug Dispensing Outlet (ADDO) in Tanzania:
  • Shop location and building design/layout—for example, ADDOs must be at least 500m from a pharmacy, be built of permanent materials, and have at least two rooms with secure doors and windows
  • Personnel training and continuing education for owners and dispensers
  • Medicine availability—all medicines sold must be on the list of ADDO-authorized medicines, which includes 37 prescription-only medicines and selected lifesaving drugs, such as certain intravenous fluids
  • Medicine quality—all medicines sold must be registered by TFDA and stored and dispensed in an appropriate manner to lessen the likelihood of contamination or degradation
  • Stock control, handling, and record-keeping—in particular, ADDOs are required to account for all medicines dispensed or sold and keep a book for recording drug-related complaints
  • Sanitation and hygiene of the premises and personnel—for example, dispensers must wear a clean white coat and a photo identification badge; premises must have a clean water supply and be free from animals and vermin
  • Code of ethics and conduct—owners and dispensers are required to follow this code
Implementation Activities Tools/Resources
  • or draft regulations and standards for accredited drug sellers
  • accreditation process

  • what drugs accredited shops can sell

  • Draft drug shop inspection protocols and procedures



Reviewed and revised draft standards, which were approved by TFDA technical committees. The TFDA approved standards for ADDO facilities, including inspection and sanctions, personnel requirements, training and continuing education, formulary development and use, medicine quality, record-keeping, code of business ethics, dispensing practice, reference materials, and wholesalers. TFDA approval was the final step before the standards were approved by the Minister of Health and Social Welfare and signed into law.

The TFDA had clauses placed in the Tanzania Food and Drug Bill, as it passed through Parliament that empower TFDA to establish ADDOs and the regulations governing them. The Minister of Health and Social Welfare approved and signed into law legally enforceable standards and a code of ethics. The ADDO standards and code of ethics were developed with the active involvement of all stakeholders, who were sought out and included through a comprehensive, wide-ranging consultative process. Altogether, nearly 400 people participated, including regional and district medical officers, members of parliament, councilors, and owners of DLDB.

First set of DLDBs enter applications to become ADDOs; first shops selected for training and accreditation.

Conduct pre-accreditation inspection to let shop owners know what they needed to do to become accredited.

Conducted a final inspection to assure that premises meet prescribed standards to receive certificate to operate as an ADDO.

An important change in the regulations was giving ADDOs permission to sell some prescription medicines at TFDA’s discretion to make it easier to fill gaps in public sector availability. The expanded medicine list for ADDOs includes some prescription and basic lifesaving medicines based on what is approved for primary health care facilities in the public sector.