Pharmaceutical dealers shall not purchase or sell drugs or medical devices of unknown sources or from dealers not holding pharmaceutical dealer permit licenses.

Drugs requiring prescription of a physician shall not be dispensed or supplied in the absence of such prescription, except under any of the following circumstances:
1. In which drugs are wholesaled or sold between pharmaceutical dealers in the same business;
2. In which drugs are purchased by hospitals, clinics, organizations, medical care institutions of schools or laboratories, and academic research institutions; or
3. In which drugs are dispensed in accordance with the formula set forth in the Chinese Pharmacopoeia and the official National Formularies.
Drugs requiring the prescription of physicians set forth in the preceding Paragraph shall be designated separately with reference to the Chinese medicines and western medicines by the central competent health authority.

Dealers or western medicines shall not concurrently sell Chinese medicines, and nor shall dealers of Chinese medicines sell western medicines, expect over-the-counter drugs.

Dealers of drugs shall not concurrently sell pesticides, drugs for annual use, or other toxic substances.

Drugs imported by dealers of drugs may be sold after repackaging conducted according to the following:
1. For pharmaceutical preparations: After approval for repackaging is obtained from the central competent health authority, the repackaging shall be conducted by manufacturers that meet the GMP standards for drugs.
2. For raw materials: repackaging shall be conducted by manufacturers that meet the GMP standards for drugs; and, after repackaging, the repacked products shall be filed with the central competent health authority for record. The conditions, procedures the timeframe and procedure for filing the above-mentioned repacked products competent shall be established by the central competent health authority, as well as matters to be complied with for selling the repackaged products.

Business undertakings engaged in wholesaling, importing and exporting pharmaceuticals, their product procuring, holding, supplying related to the quality management, organization and personnel, premises and equipment, documentation, operation procedures, customer complaints, returns and recalls, outsourced activities, self-inspections, transportation and other pharmaceuticals distribution practice, shall meet the standard of Western Pharmaceuticals Good Distribution Practice Regulations, and shall obtain the western pharmaceuticals distribution license upon the inspection and approval from the central competent health authority.
The contents from previous paragraph shall be enforced in several phases. The enforcements of pharmaceuticals and the types of pharmaceutical firms, requirement, methods and schedules shall be announced by the central competent health authority.
Business undertakings who meet the standard of paragraph 1 obtaining the western pharmaceuticals distribution license, may pay the corresponding application fees to apply for certificates with the central competent health authority.
Western Pharmaceuticals Good Distribution Practice Regulations and western pharmaceuticals distribution license of paragraph 1, the application requirements, review procedures and criteria, approval and issuance, validity period, revocation, return and cancellation of the license of the previous paragraph and other matters requiring compliance shall be prescribed by the central competent health authority.

For the purpose of protecting national interests, the central competent health authority may enforce a control over the import of the drugs or medical devices which have been granted a medicament import permit license. However, this provision does not apply to those medicaments for which foreign exchange settlement certificate has been approved prior to the enforcement of such import control.

Samples or gifts of medicaments which have been approved for manufacturing or import, shall not be sold.
Regulations governing management of samples and gifts referred to in the preceding Paragraph shall be established by the central competent health authority.

Where any medicament manufactured and sold under official approval is intended to be sold abroad through export and if literal certificate is required by the importing country, the manufacturer of such medicament shall apply to the central competent health authority to issue an export certificate prior to the exportation thereof.
The central competent health authority may, in consideration of the insufficiency to meet domestic demands, restrict or limit the export of the medicament(s) referred to in the preceding Paragraph.

The manufacture of medicaments shall be done by medicament manufacturing factories. Any medicament manufacturing factory shall be established pursuant to the Standards for Medicament Factory Establishment, and shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent health authority, is for research and development purposes.
For purposes of medicament manufacture, the factory facilities, equipment, organization and personnel, production, quality control, storage, logistics, handling of customer complaints, and other matters requiring compliance shall comply with the good manufacturing practices for medicaments; the manufacture may only begin after the central competent health authority has completed its inspection and granted approval and the medicament manufacture license has been obtained. These restrictions do not apply to manufacturers of medical devices that, per public announcement by the central competent health authority, do not need to comply with the good manufacturing practice for medicaments.
A pharmaceutical firm that has met the requirements of the preceding paragraph and obtained the medicament manufacture license may pay the corresponding application fees to apply for certificates with the central competent health authority.
The provisions of the preceding two paragraphs shall apply mutatis mutandis to overseas manufacturing factories importing medicaments, and the central competent health authority shall send personnel overseas to inspect such foreign manufacturing factories on a periodical basis or as necessary.
The Standards for Medicament Factory Establishment of paragraph 1 shall be jointly prescribed by the central competent health authority and the central competent industry authority. The good manufacturing practices for medicaments of paragraph 2 shall be prescribed by the central competent health authority.
The medicament manufacture license of paragraph 2, the application requirements, review procedures and criteria, approval and issuance, validity period, revocation, return and cancellation of the certificates of paragraph 3, and other matters requiring compliance shall be prescribed by the central competent health authority.
Article 57-1Institutions or companies for the research and development of medicaments, their products shall be manufactured by factories or establishments in accordance with central competent health authority regulations.
The factories or establishments referred to in the preceding Paragraph shall not, concurrently, manufacture other products without authorization from the central competent health authority. Medicaments manufactured for research and development purposes by said factories or establishments shall not be used on human body without authorization from the central competent health authority.

Institutions or companies for the research and development of medicaments, their products shall be manufactured by factories or establishments in accordance with central competent health authority regulations.
The factories or establishments referred to in the preceding Paragraph shall not, concurrently, manufacture other products without authorization from the central competent health authority. Medicaments manufactured for research and development purposes by said factories or establishments shall not be used on human body without authorization from the central competent health authority.

A medicament manufacturing factory may not commission another factory to manufacture or to accept the commission from another factory to manufacture any medicament, unless otherwise approved by the central competent health authority.