Key Benefits:
The Prime Minister,
On the report of the Minister of Health, Youth and Sports,
Considering the public health code, including article L. 5126-14;
The State Council (Social Section) heard,
Decrete:
Section 1 of Chapter VI of Title II of Book I of Part 5 of the Public Health Code is amended as follows:
I. - Its title is as follows:
“Section 1
"Pharmaces for the internal use of health facilities, hospitals of the armed forces, cosmetic surgery facilities, medical-social institutions, inter-hospital unions, health cooperation groups and prisons"
II. - Subsection 1 is amended as follows:
1° In the first paragraph of article R. 5126-2, after the words "medico-social" are inserted the words ", from an arm's hospital".
2° The last six paragraphs of R. 5126-3 are deleted.
3° In R. 5126-4, the words: "the structures listed in 1, 2 and 3 of R. 5126-3 managed by the health institutions members of these unions" are replaced by the words: "the different geographical sites of the member institutions" and the words: "in the first paragraph of the same article" are replaced by the words: "in R. 5126-3".
4° Section R. 5126-5 is replaced by the following provisions:
"Art. R. 5126-5. - By derogation from articles R. 5126-2 and R. 5126-3, a pharmacy may be established for internal use in any place dependent on an establishment, group or trade union referred to in R. 5126-2 with a view to:
« 1° To supply other pharmacies for internal use of this establishment or members of this union or grouping;
« 2° To ensure the sterilization of medical devices;
« 3° To sell sterile medicines and medical devices to the public under the conditions provided for in Article L. 5126-4;
« 4° To dispense the medications, products or objects referred to in Article L. 5121-1, Articles L. 4211-1 and L. 5137-1, as well as sterile medical devices to patients supported by:
“(a) Home hospitalization structures mentioned in the 3rd of Article R. 6121-4;
“(b) Home dialysis units mentioned in the 4th of Article R. 6123-54.
"The operation of the pharmacy ensuring one or more of the missions mentioned in 1° and 2° above allows pharmacy for internal use to meet the conditions of dispensation provided for in R. 5126-3.
"In pharmacies that serve the units mentioned in the 4th, the organization of the dispensation must ensure the daily needs of patients taken care of in a timely manner to respond to urgent requests. »
5° The first paragraph in R. 5126-6 is inserted as follows: "For the purposes of articles R. 5126-2 and R. 5126-3, the penitentiary institution or the administrative detention centre shall be a geographical site of the health facility that shall carry out the duties of the public hospital service. »
III. - Subsection 2 is amended as follows:
1° Section R. 5126-8 is supplemented by the following paragraph:
"The home dialysis units and the autodialysis units referred to in R. 6123-54 can only hold and dispense drugs, products or objects as well as sterile medical devices directly related to dialysis. »
2° Section R. 5126-9 is amended to read:
(a) At 3°, the words "at 13 of Article L. 5311-1" are replaced by the words "at Article L. 5137-1";
(b) After the 6th of the article, the 7th and 8th are inserted as follows:
« 7° The sale of medicines to the public under the conditions laid down in article L. 5126-4;
« 8° The realization of masterly or hospital preparations, the replenishment of pharmaceutical specialties and the sterilization of medical devices on behalf of other liberal health institutions or professionals, under the conditions provided for in the fifth and sixth paragraphs of Article L. 5126-2 and Article L. 5126-3. »
(c) The following two paragraphs are added:
"The activity under 7° is reserved for pharmacies for indoor use in health facilities, with the exception of those exclusively dedicated to home hospitalization structures, home dialysis units or self-dialysis units.
"The provisions of articles L. 5126-4 and L. 5126-11 are applicable to the hospitals of the armed forces as well as to the inter-hospital unions and health cooperation groups that manage pharmacies for domestic use. »
3° Section R. 5126-10 is amended as follows:
(a) The first two paragraphs are replaced by the following:
"By derogation from the provisions of R. 5126-8, a pharmacy for internal use may be authorized to ensure:
« 1° Some of its control operations by a subcontracting laboratory under a written contract. In this case, the stewardship pharmacist ensures that the subcontractor laboratory has the competence and sufficient means to perform the services; it justifies the use of subcontracting to the regional inspection of the pharmacy or, if requested by the pharmacy of an armed hospital, to the technical inspection of the pharmaceutical services of the armed forces. When the subcontractor laboratory is part of a pharmaceutical manufacturing facility, subcontracting activity is authorized by the French Health Product Safety Agency;
« 2° All or part of its master preparations, by a pharmacy for internal use under the conditions set out in the fifth paragraph of Article L. 5126-2 and Article L. 5126-3;
« 3° All or part of its sterile master preparations by other pharmacies under the same manager; if the delegant pharmacy is used exclusively for home hospitalization structures, home dialysis units or self-dialysis units, this authorization may be granted to the pharmacy for all master preparations and for the division of officinal products;
« 4° The issuance of medical gases for hospitalized patients at home by the legal persons referred to in Article L. 4211-5. »
(b) Its penultimate paragraph is supplemented by the following sentence: "The competent administrative authority under section R. 5126-16 or section R. 5126-16-1 shall immediately be kept informed of the adoption of such an organization and of the anticipated duration of its implementation. »
(c) Its last paragraph is deleted.
4° Section R. 5126-14 is amended as follows:
(a) In its first paragraph, after the word: "operate" are inserted the words: "on each of their sites";
(b) The item is supplemented by the following paragraph:
"The decrees provided for in this article shall, where appropriate, establish specific provisions for pharmacies serving hospital facilities at home or home dialysis units. »
IV. - Sub-section 3 is amended as follows:
1° Section R. 5126-15 is amended as follows:
(a) At 1°, the words: "The number of beds and places to be served" are replaced by the words: "The number of patients to be taken care of daily";
(b) At 2°, the words: "including, where applicable, the issue to the public of sterile medicines or medical devices pursuant to Article L. 5126-4" are deleted.
(c) The 3rd is supplemented by the words: "as well as their time of presence expressed in half-day weekly".
(d) The 5 and 7° are replaced by the following:
« 5° The location(s) of the pharmacy, the location(s) of its premises on each pharmacy and, where applicable, the location(s) of the pharmacy, the location(s) of its premises on each of them and, where applicable, the geographic location(s) of which the pharmacy is intended, as well as the geographic area of intervention of the hospitalization structures at home or of the home dialysis units served by the pharmacy; »
« 7° The terms and conditions envisaged for the dispensation or possible withdrawal of the drugs and products or objects mentioned in articles L. 4211-1 and L. 5137-1 as well as sterile medical devices, on the site(s) served by the pharmacy as well as in the domicile of patients supported by a home hospitalization structure or a home dialysis unit; "
(e) At 11°, the words "in the second paragraph of this article" are replaced by the words "in the same article".
(f) The article is supplemented by a 12° as follows: "12° When the authorization is requested by a home dialysis unit or a unit of autodialysis, the file also specifies the different categories of medicines, products, objects and medical devices dispensed."
2° Section R. 5126-16 is amended as follows:
(a) In the first paragraph, the words "Section D or E" are replaced by the words "Section E or H".
(b) The second and third paragraphs are replaced by the following:
"The authorization states:
« 1° The location(s) of the pharmacy and the location(s) of its premises;
« 2° Activities at each location site and, where applicable:
“(a) The other geographical sites served;
“(b) The geographic area of intervention of home hospitalization structures or home dialysis units;
"(c) Health institutions or professionals benefiting from the benefits provided under Article 8 R. 5126-9;
"(d) Derogations granted under 1 to 4° of Article R. 5126-10 and the conditions under which the activities under consideration are insured;
« 3° The time of presence of the pharmacist responsible for stewardship, expressed in half-day weekly. »
(c) In the fourth paragraph, the words: "who then appear in the authorization" are deleted.
(d) The sixth preambular paragraph is deleted.
(e) In the last paragraph, the words: "hospital preparations or sterilization of medical devices" are replaced by the words: "the activities referred to in article R. 5126-9, with the exception of those mentioned at its 3° and 7°".
3° After the article R. 5126-16, an article R. 5126-16-1 is inserted as follows:
"Art. R. 5126-16-1. - In the hospitals of the armed forces, the authorization to create a pharmacy for internal use or to transfer a geographic site to another is issued by the Minister of Defence.
"Previously to this decision, the Minister of Defence shall, for advice, transmit to the Minister of Health a record containing the information referred to in R. 5126-15.
"The authorization includes the references provided for in section R. 5126-16.
"A copy of this authorization is forwarded to the Minister of Health and, in the case provided for in the last paragraph of section R. 5126-16, to the Director General of the French Health Products Agency. »
4° Section R. 5126-17 is amended as follows:
(a) In the first paragraph, the words "by the competent administrative authority" are replaced by the words "by the director of the regional hospitalization agency or by the prefect".
(b) In the last paragraph, the words: "The competent administrative authority" are replaced by the words: "The director of the regional hospitalization agency or the prefect".
5° Section R. 5126-19 is replaced by the following provisions:
"Art. R. 5126-19. - The modification of the elements in the original authorization is authorized under the same conditions as those provided for in sections R. 5126-15 to R. 5126-17. However, among the information listed in section R. 5126-15, only information shall be transmitted to the Director of the Regional Hospital Agency or to the Prefect and, in the procedure provided for in section R. 5126-16-1, to the Minister for Health, to assess the nature and importance of the amendment. »
6° Section R. 5126-20 is replaced by the following provisions:
"Art. R. 5126-20. - Where the proposed amendment is to ensure all or part of the activities referred to in 8th of section R. 5126-9, the record provided for in section R. 5126-15 shall contain only the information elements listed in the article to assess the nature and importance of the needs of the beneficiary of the benefit and the means available to the pharmacy provider.
"The authorization shall be granted in the light of the agreement provided for in Article L. 5126-3, after notice of the regional inspection of the pharmacy or technical inspection of the pharmaceutical services of the armies, if the benefit is provided by the pharmacy of an armed hospital.
"Where the provider and the recipient are not under the same administrative authority, the authorization shall be issued after notice of the competent authority in respect of the beneficiary under R. 5126-16 or R. 5126-16-1.
"The authorization is granted for a maximum of five years. It is renewable under the conditions provided for its initial allocation.
"The benefit must be provided under conditions that allow recipient establishments to meet the exemption requirements set out in R. 5126-3 and health professionals to meet the needs of their patients, including urgently.
"When the preparations and reconstructions are made from pharmaceutical specialties classified in the categories defined in 1° to 5° of Article R. 5121-77, the authorization can only be granted if the quality of the beneficiaries and the terms of the agreement provided for in Article L. 5126-3 guarantee that the benefits will be provided under the conditions defined by Articles R. 5121-83, R. 5121-8591, R. 5121-85, R. 5121 »
7° Section R. 5126-21 is supplemented by the following paragraph: "The Minister for Defence authorizes the removal of pharmacies for internal use in armed hospitals under the conditions set out in section R. 5126-16-1. »
8° In the two paragraphs of R. 5126-22, after the words: "the competent administrative authority" are inserted the words: "under R. 5126-16".
V. - Sub-section 4 is amended as follows:
1° In the title of paragraph 1st, after the words "public law" are inserted the words ", hospitals of the armies".
2° The last three paragraphs of R. 5126-24 are replaced by the following:
« 1° Head of pole, in the exclusive pharmaceutical activity poles that do not have internal structures or that only have functional units;
« 2° Responsible for an internal pharmacy structure other than a functional unit, in other clinical or medico-technical activity poles. »
3° Section R. 5126-25 is repealed.
4° In R. 5126-26, the reference to R. 711-6-15 is replaced by a reference to R. 6141-30.
5° Section R. 5126-28 is replaced by the following provisions:
"Art. R. 5126-28. - In inter-hospital unions and public law health cooperation groups, the stewardship of the pharmacy for internal use is entrusted to one of the pharmacists made available to the union or group by the establishments that are members of it. Among pharmacists made available by a public health institution, only practitioners mentioned in the 1st of section L. 6152-1 can provide stewardship. »
6° Section R. 5126-29 is replaced by the following provisions:
"Art. R. 5126-29. - The stewardship of pharmacies for internal use in the hospitals of the armies is ensured by certified pharmacists of the health service of the armies or accredited practitioners of the health service of the armies appointed as the official or chief of service of a pharmacy for internal use, by a decision of the Minister of Defence. »
7° In article R. 5126-30, the words: "as mentioned in article R. 5126-25 must, when they" are replaced by the word "who" and, before the words "have been the object", is inserted the word "must".
8° Section R. 5126-31 is repealed.
9° Article R. 5126-32 is amended as follows:
(a) In the first paragraph, the word "interested" is replaced by the word "manager";
(b) In the second paragraph, the words: "is subordinated to" are replaced by the words: "is the result of";
(c) The last paragraph is deleted.
10° Section R. 5126-33 is repealed.
11° In article R. 5126-34, it is added a last paragraph as follows:
"This typical contract may include specific clauses for the stewardship of pharmacies of home hospitalization structures and home dialysis units. »
12° Article R. 5126-35 is amended as follows:
(a) Its 1° is replaced by the following: "1° The attendance time that the pharmacist must ensure and its weekly distribution; »
(b) In the last paragraph, the words: "belonging to one of the categories of practitioners referred to in the 1st of Article L. 6152-1 made available to the group under the conditions provided for by the statute to which it belongs" are replaced by the words: "available to the group by one of the member institutions".
(c) The last paragraph is supplemented by the following sentence: "Amongst pharmacists made available by a public health institution, only practitioners mentioned in the 1st of Article L. 6152-1 may provide stewardship under the conditions provided for by the statute under which they belong. »
13° Articles R. 5126-37 to R. 5126-39 are repealed.
14° The last paragraph of article R. 5126-41 is supplemented by the following sentence: "It is designated, as the case may be, by the natural person or by the legal representative of the legal person who has passed a convention with the State to ensure its health function. »
15° After paragraph 2, a paragraph 3 is inserted to read:
“Paragraph 3
“Common provisions
"Art. R. 5126-42. - The time for the presence of a pharmacist responsible for the stewardship of a pharmacy for internal use of an establishment governed by the provisions of this subsection may not be less than the equivalent of five half days a week.
"However, in medical-social establishments, this time of presence can be reduced given the needs of the people being welcomed, without being less than the equivalent of two-half days a week.
"Art. R. 5126-43. - Regardless of the cause and duration of the absence of the pharmacist responsible for the stewardship of the pharmacist for internal use, the pharmacist is replaced under the conditions defined by the statutory provisions applicable to the pharmacist or by the contract binding to the establishment.
"The replacement can only be made by a pharmacist who meets the exercise conditions defined, as appropriate, by paragraphs 1 and 2 above. The substitute is subject to the same service obligations as the pharmacist he replaces.
"In pharmacies governed by the provisions of paragraph 2 above and where the absence is less than four months, the replacement may, in addition, be made by a pharmacist who, fulfilling the conditions required under 1° and 2° of Article L. 4221-1 or having obtained the authorization provided for in articles L. 4221-9, L. 4221-11 or L. 4221-12, has applied for registration in the table of one of the national pharmacists
"Art. R. 5126-44. - Subject to the fulfilment of the terms and conditions of designation required for each of them, the same pharmacist may ensure the stewardship of two pharmacists for internal use under different managers. This number can be increased to three when the pharmacies are covered by medical-social facilities.
"These gents may be exercised provided that the pharmacist concerned can perform the time of presence that he or she must provide in each pharmacy and perform his or her duties on a daily basis, including emergencies. This shared exercise is subordinate to the condition that the pharmacist has obtained the agreement of the person responsible for his or her designation in each pharmacy; a refusal may only be opposed by the latter on grounds of health security. In the case of a hospital practitioner, the shared exercise is subject to the conclusion of the agreement under section R. 6152-4 or, where applicable, to section R. 6152-30. »
VI. - Subsection 5 is amended as follows:
1° In article R. 5126-45, the words: "as mentioned in article R. 5125-34" are replaced by the word "deputies".
2° In the second paragraph of article R. 5126-46, the words "can not exceed one year and" are deleted.
I. - Section 2 of Chapter VI of Title II of Book I of the fifth part of the code comprising sections R. 5126-54 to R. 5126-66 is repealed.
II. - 1 Section 3 of the same chapter becomes section 2.
2° Subsection 1 is amended as follows:
(a) Section R. 5126-69 is replaced by the following provisions:
"Art. R. 5126-69. - The provisions of article R. 5126-8, with respect to the activities mentioned at its 1°, those of article R. 5126-9, with respect to the activity mentioned at its 4°, as well as the provisions of articles R. 5126-11 and R. 5126-12 apply to pharmacies for internal use of departmental fire and rescue services for the products they are authorized to detain.
"The good working practices of these pharmacies as well as the conditions under which the drugs, objects or products referred to in section L. 5126-13 are held and dispensed are fixed by orders of the Minister of the Interior and the Minister for Health. »
(b) In R. 5126-72, the words "third, fifth and seventh preambular paragraphs" are replaced by the words "last preambular paragraph".
(c) In the second paragraph of article R. 5126-75, before the words "they are applicable to it", the words "as well as those of article R. 5126-23, with the exception of its third paragraph", are inserted.
(d) In R. 5126-78, the reference to R. 5126-37 is replaced by a reference to R. 5126-43.
3° Sub-section 2 comprising sections R. 5126-80 to R. 5126-91 is repealed.
4° Subsection 3 becomes subsection 2. It includes articles R. 5126-92 to R. 5126-101. In the second paragraph of article R. 5126-95, the words "before-last paragraph" are replaced by the words "eighth paragraph".
III. - Section 4 becomes section 3. It contains articles R. 5126-102 to R. 5126-110.
Section 5 of Chapter VI of Title II of Book I of Part 5 of the Public Health Code becomes Section 4. This includes articles R. 5126-111 to R. 5126-115, which are amended as follows:
1° Section R. 5126-111 is replaced by the following provisions:
"Art. R. 5126-111. - The provisions of this section shall apply:
« 1° Health institutions;
« 2° At cosmetic surgery facilities;
« 3° To medico-social institutions referred to in article R. 5126-1;
« 4° To the inter-hospital unions and authorized health cooperation groups, respectively under articles L. 6132-2 and L. 6133-1, to carry out the missions of a health establishment or, with regard to the detention and dispensation of medical gases, trade unions and groupings that manage operating blocks on behalf of their members. »
2° After the second paragraph of article R. 5126-112, two sub-items are inserted:
"The establishments referred to in R. 5126-111 may obtain reconstituted pharmaceutical specialties as well as magisterial or hospital preparations from a pharmacy for internal use or a pharmaceutical establishment referred to in L. 5124-9, authorized for this purpose under the conditions set out in R. 5126-20 and R. 5124-69 respectively.
"In inter-hospital unions and health cooperation groups, the pharmaceutical products mentioned in the preceding paragraphs may be held and dispensed under the responsibility of a pharmacist responsible for the stewardship of one of the pharmacists for internal use in member institutions. »
3° In R. 5126-113, after the words: "locked to key" are inserted the words: "or having a closure mode ensuring the same security."
4° In R. 5126-114, the words "other than those mentioned in R. 5126-112" are replaced by the words "other than those intended for urgent care".
Section 8 of Chapter I of Book I, Title II, Part 5 of the Public Health Code is amended to read:
1° Au a du 1° des articles R. 5121-83 et R. 5121-88 ainsi que au 1° de l'article R. 5121-85, après les mots : « institution de santé public ou privé », sont inserted les mots : « ainsi que dans un syndicat interhospitalier ou un groupement de coopération santé autorisation, respectivement en vertu des articles L. 6132-2 et L. 6133-1, à assurer les missions d' santé ».
2° The provisions of 1° of Articles R. 5121-83 and R. 5121-88 as well as those of 3° of Article R. 5121-85 are thus drafted: "In public health institutions other than local hospitals, to any other person authorized to prescrire acting under the responsibility of a pole official or, on delegation of the latter, of a person responsible for an internal structure of the pole, to the division. »
3° (a) At the 2nd of Article R. 5121-83, the words: "as mentioned in Article L. 5126-1" are replaced by the words: "institutions mentioned at the 1st or those of interhospital unions and health cooperation groups acting on behalf of health institutions that are members of it"; after the words: "to people" are inserted the words: "to ensure, in these institutions, the responsibilities".
(b) In 3° of the same article, the words: "or in a structure referred to in section R. 712-2-1" are replaced by the words: ", including, unless otherwise stated in the marketing authorization, the patient's home in a home hospitalization or home dialysis activity."
Section 7 of chapter IV, title II, of Book I of Part 5 of the Public Health Code is amended as follows:
1° Section R. 5124-69 is supplemented by the following provisions:
"These establishments may be authorized under the conditions set out in Article L. 5124-3 to carry out hospital preparations and replenishments of pharmaceutical specialties on behalf of public health institutions where they are located. The same authorization may, under the conditions provided for in the last paragraph of Article L. 5126-2 and in the light of a specifications guaranteeing the quality and safety of the service, allow them to entrust, under their responsibility, the completion of the above-mentioned hospital preparations to another pharmaceutical institution.
"Pharmaceutical establishments of public health institutions may be permitted, under the conditions set out in sections L. 5126-3 and R. 5126-20, to issue these preparations and reconstructions to other institutions referred to in section L. 5126-1 and health professionals involved in health networks that meet the conditions set out in the third paragraph of section L. 6321-1. »
2° The last sentence of Article R. 5124-71 is replaced by the following provisions: "For this purpose, these pharmaceutical establishments are constituted in poles of activity or internal structures of such poles, other than functional units. »
Health institutions that only provide home hospitalization or home dialysis activities have a period of six months, beginning with the publication of this Order, to comply with the provisions set out in sections R. 5126-48 to R. 5126-53 of the Public Health Code.
The Minister of Interior, Overseas and Territorial Communities, the Minister of Defence and the Minister of Health, Youth and Sports are responsible, each with respect to him, for the execution of this Order, which will be published in the Official Journal of the French Republic.
Done in Paris, October 3, 2007.
François Fillon
By the Prime Minister:
The Minister of Health,
youth and sports,
Roselyne Bachelot-Narquin
The Minister of the Interior,
the overseas and territorial authorities,
Michèle Alliot-Marie
Minister of Defence,
Hervé Morin
