Decree No. 255 / 2003 Coll.
Ordonnance laying down the proper practice of pharmacies, closer conditions for the preparation and treatment of medicinal products, dispensation and treatment of medicinal products in medical establishments and closer conditions for the operation of pharmacies and other medicinal operators
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Order
Effective from 01.09.2003
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255
DECLARATION
of 29 July 2003
laying down good pharmacy practice, closer conditions for the preparation and modification of medicinal products, dispensing and handling of medicinal products in medical establishments and for the operation of pharmacies and other medicinal product-issuing operators
The Ministry of Health and the Ministry of Agriculture, pursuant to § 75 (2) (e) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, as amended by Act No. 129 / 2003 Coll., hereinafter referred to as "the Act ':
INTRODUCTORY PROVISIONS
According to this decree, the preparation, modification, storage, intake and supply of medicinal products in a pharmacy, nuclear medicine workplace, immunobiological or microbiological workplace, and in a public health authority, as well as the treatment of medicinal products in the provision of health care and veterinary care shall be carried out.
For the purposes of this decree:
(a) individual preparation - preparation of a medicinal product according to a prescription (1) prescribed for a particular patient or animal;
(b) mass preparation - preparation of an intermediate product intended for further processing in the same medical establishment or final product of a medicinal product, without reference to a prescription prescribed for a particular patient or animal;
(c) the radiopharmaceuticals prepared for a particular patient or group of patients for specific examinations,
(d) the activity of the preparation of radiopharmaceuticals - the amount of radioactivity in the medicinal product expressed in becquerels at that date and hour,
(e) mass activity - activity and total mass of radiopharmaceuticals,
(f) volume activity - activity and total volume of radiopharmaceuticals,
(g) by standard operating procedure - a document setting out the recurring activities;
(h) a technological regulation - a dossier which prescribes the course of preparation of the medicinal product and includes, in particular, the composition of the medicinal product, the determination of the packaging material, the labelling method and the control code,
(i) triturisation - a well-coated mixture of the active substance with the excipient, usually with lactose, in proportion to the exact weighing of the active substance,
(j) shelf-life - the period during which, while respecting the prescribed storage conditions, the active substance, the auxiliary substance or the medicinal product maintains its declared properties or properties necessary for the intended use, in particular the required quality, efficacy and safety.
CORRECT DOCTOR PRACTICE AND BLIGHTER CONDITIONS OF DOCTOR OPERATIONS
Principles for the preparation and presentation of medicinal products
(1) For the preparation of medicinal products:
(a) the active substances, excipients and plants referred to in the specific legislation2) and bearing evidence of their quality3) (hereinafter referred to as the certificate);
(b) authorised mass-produced medicinal products; for solid and semi-divided formulations, the possibility of their use in preparation is given in the Summary of Product Characteristics, 4)
(c) scales allowing for the accuracy of the weighing of active substances and excipients by one order higher than the quantity considered;
(d) working items, instruments, apparatus, equipment and packaging, made of materials which do not affect the properties of medicinal products.
(2) When preparing medicinal products
(a) all operations shall be documented in such a way that the preparation procedure, quality assessment and, where the documentation is kept by an electronic system, the data shall be recovered in a renewable manner;
(b) the active substances and the excipients may not be used after their expiry date or if they are found to have been affected by organoleptic control;
(c) shall be carried out in such a way as to avoid any possibility of substitution;
(d) one worker may not prepare several different medicinal products at the same time;
(e) triturations containing vena and addictive substances for which a control laboratory has not been carried out (5) or a pharmaceutical check on the identity and content of these substances may not be used.
(3) Purified water6) is stored at not more than 25 ° C and may be used for the preparation and preparation of medicinal products for a maximum period of 24 hours after preparation; longer applicability may be allowed if it is demonstrated by laboratory tests that the quality criteria will not change for a specified period. 6) Water for injections stored in airtight containers may be used for the preparation of medicinal products for a maximum period of 24 hours from the time when the contents are damaged; purified water stored in a closed system of clean water preparation facilities may be used for the preparation or modification of medicinal products for a maximum period determined on the basis of process validation.
(4) Sterile medicinal products are prepared in premises with prescribed air purity classes, which are regularly checked; air purity classes are listed in the Annex. Work aids and packaging that come into contact with the medicinal product during preparation must be sterile. 6)
(5) In the preparation of parenteral medicinal products of the cytostatics group, the requirements for the preparation of sterile medicinal products and requirements based on the specific nature of the active substance are respected. 6)
(6) In the preparation of radiopharmaceuticals, the requirements for working with open radionuclide radionuclide lamps shall be complied with in accordance with specific legislation. 7)
(7) Apparatus which may affect the quality of the finished product shall be regularly cleaned and checked.
(8) In addition to the procedures set out in Sections 4 to 6, medicinal products shall be considered as preparation.
(a) consideration;
(b) filling,
(c) the distribution of individual packages of mass-produced medicinal products for sleeper medical devices;
(d) an adjustment which is disproportionately demanding or dangerous, in particular an adjustment
1. radiopharmaceuticals,
2.
3. medicinal products intended for parenteral nutrition.
(9) Dilution of mass-produced medicinal products other than those referred to in point (d) of paragraph 8, the dissolution or dilution of syrups, dry injections and the addition of injection solutions to infusions shall be considered to be the treatment provided that they are carried out in packages intended for that purpose or in the case of sterile medicinal products by means of sterile medical devices.
(10) In the case of non-authorised products used in accordance with § 5a (3) of the Act, as specified by the manufacturer, under the conditions laid down by the specific treatment programme or under the conditions approved for carrying out the clinical trial, only processes that comply with the Summary of Product Characteristics may be modified by mass-produced medicinal products.
Preparation of sterile medicinal products
Preparation of sterile medicinal products
(a) parenteral from sterile material of technology which excludes biological, microbiological, chemical or physical contamination shall be carried out in the working area of the air purity class A which is located in the air purity class C;
(b) parenteral takes place in the air purity class C; the requirement for sterility is ensured by thermal or microbial filtration in the air purity class A; in the same way, other sterile medicinal products are prepared without anti-microbial additives;
c) with anti-microbial additive ends with microbial filtration and expansion in the air purity class space Or, if the nature of the medicinal product so permits, by subsequent heat sterilisation,
(d) which cannot be heat sterilised shall be carried out in the working area of the air purity class A which is located in the air purity class C; sterile active substances and excipients shall be used for their preparation;
(e) a group of cytotoxic substances shall be carried out in vacuum safety boxes with vertical laminar flow of the air purity class A and towing outside the space which are located in the air purity class C.
Individual preparation
(1) If the usual dose of the active substance is exceeded and this excess is not properly indicated by the prescribing physician in the manner specified by the specific legislation1) and it is not possible to verify this with the prescribing physician, the pharmacist shall adjust the amount or concentration of the prescribed active substance to the therapeutically usual or usual, shall indicate the change on the prescription and confirm it by signature. The prescriber shall immediately inform the pharmacist of the change.
(2) If, according to the knowledge and experience of the pharmacist, a medicinal product prepared under a prescription would not meet the requirements of quality, safety and efficacy, in particular when the prescribed medicinal product contains substances incompatible or known to have an adverse effect on one another, the pharmacist shall modify the prescription in the light of a qualitative or quantitative change in the excipients or active substances. In the case of changes in active substances, this change shall be made only after prior agreement with the prescribing physician. It shall indicate the change made on the prescription, confirm it with its signature and prepare the medicinal product and issue it in accordance with the change made.
(3) If it is possible to improve the properties of the medicinal product by using appropriate excipients, the pharmacist may modify the composition of the medicinal product. It shall indicate the change on the prescription, confirm its signature and prepare and issue the medicinal product in accordance with the variation made.
Mass preparation
(1) Mass preparation shall be carried out in accordance with the technical regulation drawn up for the intermediate product.
(2) Mass preparation of the final product of the medicinal product is carried out
(a) up to 20 packages in accordance with Articles 3 to 5 and 8 (1) and (2),
(b) over 20 packages in batches provided for in Articles 3 to 5 and 8 (3).
Labelling of active substances, excipients and medicinal products
(1) The labelling of the packages in which the active substances and the excipients are kept shall be carried out, unless the packaging is marked directly, on a tight label,
(a) a oblique blue stripe from the lower left to the upper right corner of the label in the case of narcotic drugs and psychotropic substances referred to in a separate legislation, 8)
(b) in white on the black label at the venages, 6)
(c) in red on the white label for separands, 6)
(d) in black on the white label in cases not covered by (a) to (c);
(e) in addition to the labelling referred to in points (a) to (d), by the warning text "Flammable" for the active substances of flammable and auxiliary substances of flammable substances and "Thirsty" for the active substances of corrosive and corrosive aids.
In the absence of commercial (original) packaging, the mark shall include the certificate number or batch number.
(2) Prepared medicinal products for dispensing are indicated:
(a) a white label for oral medicinal products, absorption of mouth mucous membranes or injection,
(b) a red label indicating "Do not use internally" if other uses are needed,
(c) if the medicinal products are intended for animals, as referred to in (a) or (b), and a green label indicating "For animals only,"
(d) the address of the pharmacy,
(e) the date of preparation and, where the shelf life is less than 48 hours, the time of preparation;
(f) the signature of the person who prepared the medicinal product if it is prepared in accordance with Sections 5 and 6 (a),
(g) batches of the medicinal product when prepared in accordance with § 6 (b),
(h) the period of validity of the medicinal product, its storage method and instructions for use, which shall include, in particular, the method of use and the dosage of the medicinal product, if this is necessary, taking into account the nature of the medicinal product,
(i) the anti-microbial ingredient used if added during preparation; for eye preparations without anti-microbial additives, the symbol "SA ',
(j) "Poison," if specifically stated by the physician on the prescription,
(k) by composition or, where appropriate, by name, in the case of medicinal products prepared in accordance with Article 6 or for dispensing medicinal products for medical establishments or veterinary surgeons,
(l) the total quantity of the medicinal product, except for preparation as provided for in Section 5;
(m) batches of medicinal products considered,
(n) the name, surname and date of birth of the patient and the words "Cytotoxic substance," if the medicinal products are of the cytostatic group,
(o) the name, surname and date of birth of the patient, if they are parenteral medicinal products prescribed for a particular patient,
(p) the words "Flammable" in the case of flammable medicinal products, 9) and the words "Thirsty" in the case of corrosive medicinal products. 9)
(3) The labelling of medicinal products shall include:
(a) the name or composition;
(b) stage of preparation;
(c) the date of preparation;
(d) the signatory's signature.
(4) Medicinal products which are treated and are intended for dispensing to medical establishments or veterinary surgeons shall be marked with the name or composition, the particulars referred to in paragraph 2 (a) to (f), (h), (j), (l) and (p), unless such data are already on the packaging of the modified medicinal product or, where appropriate, with the information identifying the patient under the prescription.
(5) When distributing individual packages of mass-produced medicinal products, these products shall bear the name, strength or concentration, batches and shelf-life, unless such information is already on the packaging; in the case of thermolable products, the storage conditions shall also be indicated.
(6) The tests for laboratory use prepared at the pharmacy shall be marked with a yellow label marked "Examiner 'and a red label marked" Disinfectant solution'.
Monitoring of preparation and adaptation
(1) For medicinal products prepared individually or in bulk up to 20 packages of the final product of the medicinal product, the issuing person checks the appearance, quantity, packaging and labelling.
(2) For medicinal products prepared in bulk up to 20 packages of the final product of the medicinal product, the person who prepared the medicinal product controls the certificate of the active substances used and the excipients and the completeness of the dossier.
(3) For medicinal products prepared in bulk in excess of 20 packages of the final product of the medicinal product, organoleptic, chemical and physico-chemical tests shall be carried out according to the pre-prepared documentation. The sample of each batch shall be kept for the period of application.
(4
(5) For purified water a check is carried out
(a) chemical and physicochemical, namely:
1. at least once a month; and
2. after each intervention in the apparatus for its preparation,
(b) microbiological at least twice a year.
The procedure for the preparation of purified waters.6)
(6) Physically chemical or organoleptic tests shall be carried out on each package prior to the use of the active substances and excipients.
(7) After adjusting the medicinal products, the checks referred to in paragraph 1 shall be carried out.
Medicinal products
(1) In the case of medicinal products given to a patient on the receptor (1), the pharmacist shall verify the dose and method of administration indicated before dispensing. By dispensing a pharmacist
(a) it may suspend the issue of medicinal products if, according to its knowledge and experience, they are likely to be affected by one another; The prescribing physician shall consult this fact and, in the event of unattainability, shall not issue medicinal products unless there is a risk of delay; (1) any changes and the reason for not issuing them shall indicate the recipe;
(b) issue the number of packages of the medicinal product, expressed verbally, if there is a discrepancy in the recipe between the number of packages expressed in number and word.
(2) If the recipe fails
(a) the signature of the doctor;
(b) the stamp of the medical establishment if there is no danger of delay, 1)
(c) the patient's name and surname and cannot be supplemented; or
(d) the insured person's identification number and the code of the relevant health insurance undertaking where the supply of the medicinal product is covered by public health insurance and cannot be supplemented;
The pharmacist shall not issue the medicinal product.
(3) If a prescribed medicinal product is not available in the pharmacy and, in view of the patient's medical condition, immediate issue of the medicinal product is necessary, the pharmacist may replace the prescribed medicinal product with another medicinal product provided that:
(a) the patient agrees and the replacement medicinal product contains the same active substance in the same pharmaceutical form; if the replacement medicinal product contains a different amount of active substance in the unit of mass, volume or pharmaceutical form, the pharmacist shall adjust the dosage to correspond to that prescribed by the physician. The pharmacist shall inform the patient of the level of reimbursement of the replacement medicinal product and indicate the change made on the recipe, including the adjusted dosage,
(b) where the medicinal product is supplied with the same active substance as in the prescribed medicinal product, but in another pharmaceutical form, or the medicinal product is supplied with another medicinal product with similar therapeutic effects. The pharmacist shall draw the patient's attention to the substitution made, including any changes in the reimbursement of the medicinal product, and shall indicate the change on the prescription, including indication of dosage.
(4) The recipe for which the medicinal product is issued is stamped with a pharmacy, the date of issue of the medicinal product and the signature of the issuing pharmacist.
(5) Medicinal products not subject to medical prescription may also be supplied by self-service at the premises specified for that purpose and by mail.
(6) Where the required mass-produced medicinal product is not available at the pharmacy, the pharmacy may withdraw the mass-produced medicinal product from another pharmacy or, if the pharmacy has unused supplies of the mass-produced medicinal product, it may offer them to another pharmacy under the conditions laid down by law. 10)
(1) When dispensing medicinal products on demand (1), the person who issued the requestor or, where appropriate, the person responsible for taking over the medicinal products issued shall certify his signature.
(2) For the transport of prepared medicinal products of a group of injectable cytostatics or mass-produced medicinal products of a group of cytostatics for which internal packaging has been damaged during preparation, only airtight means of transport may be used to protect them from deterioration or to protect the environment from pollution. The means of transport shall be marked with the warning "Cytotoxic substance '. Similarly, other medicinal products that significantly threaten human health and the environment are also to be treated.
(3) Medicinal products prepared at a pharmacy containing vena or separanda, with the exception of medicinal products in which vena or separanda is used as an anti-microbial additive, are not to be issued without a prescription.
(4) After treatment, medicinal products shall be given to medical devices in an appropriate package taking into account the nature of the medicinal product and the manner in which they are treated in such a way that their quality is not reduced.
Medicinal products containing addictive substances and precursors
(1) Medicinal products containing addictive substances are not to be issued without a prescription or a prescription. 1) Medicinal products containing addictive substances referred to in special legislation11) may only be taken over by a doctor, veterinarian or a central healthcare professional authorised for that purpose by a natural or legal person authorised to provide medical care. The supply of medicinal products containing addictive substances to patients shall be carried out in accordance with § 9 (1), (2), (5) to (9) and § 10 (1); this shall be without prejudice to the obligations laid down in a specific legislation. 11)
(2) In the case of precursors, specific legislation shall be followed. 11)
Storage of medicinal products, active substances and excipients
(1) Active substances and excipients shall be kept under the conditions laid down by the manufacturer, the prepared medicinal products shall be kept under the conditions laid down by the person who prepared them and the mass-produced medicinal products shall be stored in accordance with the conditions set out in the Summary of Product Characteristics or the manufacturer's instructions. Compliance with the temperature set for drug storage shall be checked on an ongoing basis.
(2) Non-compliant medicinal products, which have expired, stored or prepared under conditions other than those prescribed, must be identified as unfit and kept separately from other medicinal products at the pharmacy.
(3) In the case of recall of a medicinal product, the pharmacy shall, at the request of marketing authorisation holders and drug distributors, provide information on the withdrawal process.
(4) Narcotic substances and precursors must be stored in accordance with specific legislation. 11) The active substances and the excipients classified between the vena must be kept separately in lockable lockers. Only persons with competence under specific legislation may treat venes and addictive substances; 13) other persons do not have access to these substances.
(5) Separanda should be kept in the preparation of medicinal products separately from other medicinal products.
Documentation
(1) Activities in a pharmacy associated with the reception and storage of medicinal products, active substances and excipients, the preparation or preparation of medicinal products, including their control, and the supply of medicinal products must be documented in writing or electronic form. Where activities are described by standard operating procedures or technological regulations, they shall be carried out in accordance with those documents.
(2) The documentation in the pharmacy consists of:
(a) records of:
1. acceptance of mass-produced medicinal products, including their batches, active substances, excipients and medicinal products prepared by another pharmacy,
2. the filling of active substances and excipients,
3. sterilisation of packaging and medicinal products, articles and equipment,
4. the control of the active substances and excipients received,
5. preparation and control of medicinal products prepared in bulk, including records of the release of each batch of medicinal products prepared in bulk in excess of 20 packages; such records shall be signed by the lead pharmacist or by the authorised person,
6. control of prepared purified water and water for injections,
7. prescribed checking of instruments,
8. prescribed inspection of premises with a specified air purity class;
9. Complaints due to quality defects and recall of medicines;
10. dispensing of medicinal products to medical devices on demand;
11. the provision of a mass-produced medicinal product to another pharmacy; such records shall indicate the lot of the medicinal product, including the code;
12. control of the integrity of the safety box for the preparation of medicinal products containing cytotoxic substances; This check shall be carried out once a week,
13. Temperature of storage of medicinal products, active substances and excipients,
(b) prescriptions for fully paid medicinal products and veterinary medicinal products;
(c) technological regulations;
(d) standard operating procedures;
(e) substance and precursor records, 11)
(f) operating rules;
(g) additional documentation relating to the preparation and modification of medicinal products and the operation of the pharmacy, including the operating rules and the workload of medicinal persons;
(h) recipes and applications for medicinal products containing addictive substances, 13)
(i) the stock records of the intake and supply of medicinal products by item, allowing a distinction between the pharmaceutical form, the quantity of the active substance contained in the unit of mass, volume or unit of the pharmaceutical form and the package size of the medicinal product including the code of the medicinal product.
(3) The technological regulation dated and signed by the lead pharmacist (14) contains the procedure for the preparation of the medicinal product, including the quantity of the active substance in the unit of mass or volume, and the procedures for carrying out the preparation controls, including the extent of such checks, indicating the values to be achieved, including the period of application. The technological regulation shall be kept up to date and the amendments made shall be marked in such a way as to preserve the original text dated and signed by the pharmacist's manager. The date of expiry shall be indicated on the non-use technology prescription and shall be accompanied by the signature of the lead pharmacist. Where the European Pharmacopoeia or the Czech Pharmacopoeia [§ 7 (d) and (e) of the Act] contains provisions relating to the product or the technological regulation, those provisions shall be taken into account in the technological regulation.
(4) The documentation shall be kept for at least 5 years from the date of the last registration. The recipes referred to in paragraph 2 (b) shall be kept for a period of 6 months from the date of issue of the medicinal product.
PREPARATION OF RADIOFARMS AND BLIGHTER CONDITIONS OF OPERATING NUCLEAR MEDICINES OF HEALTH EQUIPMENT
Principles for the preparation of radiopharmaceuticals
(1) In the preparation of radiopharmaceuticals, the principles of good pharmaceutical practice set out in Sections 3 to 5 and 6 (a) shall be respected mutatis mutandis. Radiopharmaceuticals shall be prepared at the premises of the holder of the authorisation for the treatment of source of ionising radiation in accordance with specific legislation. 15)
(2) Radiopharmaceuticals are prepared according to:
(a) special legislation, 6)
(b) summaries of product characteristics for authorised medicinal products, (4); or
(c) technological regulations or standard operating procedures taking into account rules for the handling of radioactive substances. 7), 15)
(3) If blood components or other biological material collected from a patient in a nuclear medicine workplace are used in the preparation of radiopharmaceuticals, the ready-to-use radiopharmaceuticals may only be used for the patient from whom the collection was carried out.
(4) Radiopharmaceuticals are preparing
(a) by changing the volume activity of mass-produced radiopharmaceuticals;
(b) mixing the kit components with the radionuclide solution for injection,
(c) incubation of biological material with radionuclide solution in appropriate chemical form;
(d) the eradication of radionuclide generators in accordance with the SPC.
Working procedures
(1) During the preparation of radiopharmaceuticals, several different radiopharmaceuticals in one workplace.7) Preparation of radiopharmaceuticals for the use of blood components or other biological material taken from patients shall take place at a post reserved for this purpose only.
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Regulation Information
| Citation | Decree No. 255 / 2003 Coll., laying down the correct practice of pharmacies, closer to the conditions for the preparation and treatment of medicinal products, dispensation and treatment of medicinal products in medical establishments, and closer to those of pharmacies and other medicinal operators |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.08.2003 |
|---|---|
| Effective from | 01.09.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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