Government Decree No. 5 / 1947 Coll.
Czechoslovak Pharmacopoeia Regulation
Valid
Effective from 27.01.1947
5.
Government Regulation
of 14 January 1947
about Czechoslovak Pharmacopoeia.
The Government of the Czechoslovak Republic hereby orders, pursuant to Article 7 of the Law of 18 December 1906, No 5 of 1907 on the treatment of pharmaceuticals and Article 137 of the Law on Public Health:
(1) The Minister for Health is hereby authorised to issue, amend and supplement the "Czechoslovak Pharmacopoeia, Edition I. - ČsL I." (hereinafter referred to as Pharmacopoeia) in order to comply with scientific progress.
(2) The Minister for Health will publish in the Official Journal when and where the Pharmacopoeia (its amendments and additions) has been issued and determine the date on which it becomes effective.
(1) The pharmacists who personally operate a public pharmacy and the responsible managers of public or constitutional pharmacies are obliged to obtain at least one copy of the pharmacopoeia, to know its contents and to follow it.
(2) Magistrates of pharmacy employed in public and constitutional pharmacies are also obliged to know and follow the content of the pharmacopoeia.
The facilities of public, constitutional (in Slovakia also filial) and domestic medical and veterinary pharmacies must comply fully with the rules of the pharmacy.
Public and constitutional pharmacies must still have sufficient quantities of all the medicines and medicinal products listed in the Pharmacopoeia (the official medicines).
Oficinal medicinal products are allowed only in stock in the quality prescribed by the pharmacopoeia and are stored and delivered according to its provisions.
(1) Medicinal products for which a prescription is provided for in a pharmacopoeia may only be prepared in accordance with this Regulation from medicinal products (components) of the prescribed quality.
(2) Medicaments prepared, reared and issued in pharmacies according to the Pharmacopoeia or the medical (veterinary) prescription must also be prepared from medicines of the prescribed quality (s).
Containers of medicinal products for which the authorised shelf life is fixed by the pharmacopoeia shall be marked with the date of their preparation.
(1) The pharmacists and the responsible administrators referred to in Article 2 (1) are required to be convinced before using official pharmaceuticals in the operation of the pharmacy, whether they comply with the rules of the pharmacopoeia.
(2) If an official drug in a pharmacopoeia does not indicate how to test it, it should be examined by a scientifically reliable method.
A very potent official medicine (Venena), listed in the Pharmacopoeia table marked "I ', must be kept in a locked cabinet in bottles with sharpened cross-stoppers. Their name and maximum doses must be written on both the container and the stopper in white letters on black soil.
Strongly performing official medicinal products (Separanda), listed in the Pharmacopoeia table to be marked II, must be kept in the pharmacy separately from others in bottles with sharpened cross-stoppers or in porculan bottles with caps. Their name and maximum doses must be written on both the container and the cap in red letters on the white soil.
The strong-acting official medicinal products (Separanda) listed in the Pharmacopoeia table, marked III, must be kept completely separate from the medicinal products listed in Table II so that their properties do not jeopardise the quality of other medicinal products. Bottles for these medicinal products do not need to have a cross-stoppers marked if their maximum doses are not indicated in the Pharmacopoeia. In others, the provisions of Section 10 apply to their retention.
(1) The maximum doses for an adult listed in the Pharmacopoeia table, marked IV, may be exceeded when issuing the appropriate internal use medicines only if the doctor has obtained the dose on the prescription in words and an exclamation mark is added to it.
(2) The highest doses of medicinal products which are not listed in Tables I, II and III of the Pharmacopoeia must only be written on the container in red letters and figures under the black inscription of the name of the medicinal product on the white soil.
Oficinal medicinal products listed in the table of pharmacopoeia, which are marked V, must not be issued without a medical (veterinary) prescription, even if they are modified or mixed in any way.
(1) The probers and volumetric solutions listed in the Pharmacopoeia tables to be marked VII and VIII, as well as the containers, tools and apparatus forming part of the reagent cabinet (apparatus reagentium), as indicated in the Pharmacopoeia table to be marked IX, must always be in each public and constitutional pharmacy in a timely and impeccable state.
(2) The receptacles for the storage of probers and volumetric solutions must be labelled with the Czech, Slovak or Latin inscriptions listed in Tables VII and VIII of the Pharmacopoeia.
(1) If a pharmacopoeia indicates certain medicinal products in two classes (raw and cleaned or treated) and the medical prescription does not specify the quality, a better quality must be given.
(2) If a drug is indicated in a pharmacopoeia at two concentrations and the concentration is not specified on the prescription, the drug must be more diluted.
(1) In pharmacies, medicines and medicinal products which are not included in the pharmacopoeia, as well as medicinal products and medicinal products newly introduced into the thorapia (hereinafter referred to as neophic medicines), may be kept and dispensed into the thorapia.
(2) Neophic medicinal products must be of the best quality and must not be contaminated or broken. The pharmacists and the responsible administrators referred to in Paragraph 2 (1) shall be required to convince themselves of these characteristics by a scientifically reliable method before they start using such a medicine in the operation of the pharmacy.
(1) Neophic medicinal products newly introduced into therapy must always be kept completely separate from all other medicinal products and preparations either in the original commercial packaging or in the usual well-sealed containers, in the most suitable manner for them according to their nature, after the method prescribed for the vena or for the separanda (§ § 9 to 11). These medicines and all forms of medicines containing them may only be given on medical (veterinary) prescription.
(2) Other neoficinal medicinal products should be stored in the same way and with the same care and dispensed with the same caution as the similarly composed or similarly acting oral medicinal products. Those who are strongly and very strongly effective, or for whom the highest doses are determined, may only be given on a prescription. The same applies to all forms of medicines containing such neophic medicines.
Doses of potent and very potent neophic drugs must be marked on the prescription not only by figures, but always by words.
The highest doses of neophic drugs are laid down by the Ministry of Health in the Official Journal.
(1) Medicinal specialities, organotherapy, hormonal, vitamin, radioactive, diagnostic, medicinal products and other sera, vaccines and microbial products may also be kept in pharmacies.
(2) These products may be issued only on medical (veterinary) prescription, except for those medicinal specialities which are not covered by the provisions of § 6 (2) (d) of the Decree of 19 February 1926, No 26 Coll., on the manufacture and trade of medicinal specialities in pharmacies.
The Ministry of Health may, if the public interest of the health sector so requires, provide for exceptions to the provisions of Sections 13, 17 and 20. These measures shall be published in the Official Journal.
Transfers of the provisions of this Government Regulation shall be punishable without prejudice to possible prosecution under the provisions of Section IV of Law No 5 / 1907, or under Section 7 of Article XIV / 1876.
(1) The validity, where applicable, of all provisions contrary to the provisions of this Government Regulation shall be revoked on the date on which the pharmacopoeia takes effect (§ 1 (2)).
(2) In particular, the validity, where applicable:
1. the Ordinance of the Ministry of the Interior of 8 January 1906, No 10, on the eighth edition of Austrian Pharmacopoeia,
2nd Order No. 100.000 / 1909 B. M. on the third edition of Hungarian Pharmacopoeia,
3rd Government Decree of 19 December 1940, No 161 Coll. of 1941, on a new Pharmacopoeia,
4. the Ordinance of the Minister for the Interior of 16 April 1942, No 220 Coll., on the issue of new regulations on the operation of pharmacies,
5. Ordinance of 7 July 1942 of the Ministry of the Interior No 658 Ú. l., on medicines, medicines and medicines which are not permitted to be issued without a prescription authorised by the doctor (veterinarian),
6. the Ordinance of the Ministry of the Interior of 7 July 1942 on the test equipment required for testing under German Pharmacopoeia, and
7th Ordinance of the Ministry of the Interior of 7 July 1942, ed. 660 Ú. l., on examiners required for testing according to the German Pharmacopoeia.
This Regulation shall enter into force on the day of its publication; they shall be carried out by the Minister for Health.
Gottwald v. r.
Dr Zenkl v. r.
Ursines v. r.
Fierlinger v. r.
Broad v. r.
Maj-Gen Svoboda v. r.
Dr. Ripka v. r.
Nosek v. r.
Dr Dolansky v. r.
Dr Stránská v. r.
Dr Drtina v. r.
Kopecký v. r.
Děuriš v. r.
Wasted v. r.
Hala v. r.
Dr. Unedible v. r.
Dr Procházka v. r.
Majer v. r.
Dr Franek v. r.
Lichner v. r.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Government Decree No. 5 / 1947 Coll., on Czechoslovak Pharmacopoeia |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.01.1947 |
|---|---|
| Effective from | 27.01.1947 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0