{"id":74047,"date":"2025-10-08T08:42:54","date_gmt":"2025-10-08T07:42:54","guid":{"rendered":"https:\/\/fagroncompoundingservices.be\/?page_id=74047"},"modified":"2026-06-05T15:34:05","modified_gmt":"2026-06-05T14:34:05","slug":"agreement-regarding-the-outsourcing-to-a-compounding-pharmacy","status":"publish","type":"page","link":"https:\/\/fagroncompoundingservices.be\/en\/agreement-regarding-the-outsourcing-to-a-compounding-pharmacy\/","title":{"rendered":"Agreement regarding the outsourcing of compounded preparations"},"content":{"rendered":"\n<p>Click on the individual agreement to view the text.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<details class=\"wp-block-details\"><summary><mark style=\"background-color:rgba(0, 0, 0, 0);color:#e6352b\" class=\"has-inline-color is-layout-flow wp-block-details-is-layout-flow\">&gt; Agreement regarding the outsourcing to a compounding pharmacy<\/mark><\/summary>\n<p><\/p>\n\n\n\n<p>Article 1 \u2013 Definitions<\/p>\n\n\n\n<p>The applicant is the pharmacist who delegates the performance of a magistral preparation.&nbsp;<\/p>\n\n\n\n<p>The contractor is the party engaged by the applicant to perform the preparation on their behalf.<\/p>\n\n\n\n<p>Magistral preparation: In this Agreement, the term \u201cmagistral preparation\u201d shall be used throughout. It is understood that \u201cmagistral preparation\u201d is synonymous with \u201ccompounded medication.<\/p>\n\n\n\n<p>Article 2 \u2013 Type of magistral preparation<br>The contractor represents and warrants that it possesses the necessary facilities, adequate equipment, raw materials, and resources required to perform the following magistral preparation:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Solid forms: capsules, granules, powder mixtures, whether or not divided, in unit doses;<\/li>\n\n\n\n<li>Semi-solid preparations for cutaneous use, as defined in the Therapeutic Magistral Formulary (TMF);<\/li>\n\n\n\n<li>Solutions for internal and external use, whether liquid or otherwise, excluding those that must be sterile;<\/li>\n\n\n\n<li>Sterile solutions for internal and external use;<\/li>\n\n\n\n<li>Liquid emulsions and suspensions for internal and external use;<\/li>\n\n\n\n<li>Suppositories.<\/li>\n<\/ul>\n\n\n\n<p>Article 3 \u2013 Obligations of the contractor<\/p>\n\n\n\n<p>The contractor confirms that it complies with the requirements of the Royal Decree of 21 January 2009 concerning the assignment to pharmacists, including any amendments thereto, and that it has notified the Federal Agency for Medicines and Health Products (FAMHP) of this activity. This notification remains valid. Should this notification become wholly or partially invalid, the contractor shall immediately inform the applicant, provide the reasons for such invalidity, and forward the relevant FAMHP document.<\/p>\n\n\n\n<p>The contractor shall be reachable outside the normal opening hours of its pharmacy at the e-mail address listed in the register of affiliated compounding pharmacies at&nbsp;<a href=\"https:\/\/fagroncompoundingservices.be\/en\/subcontractors\/\">https:\/\/fagroncompoundingservices.be\/en\/subcontractors<\/a>.&nbsp;<\/p>\n\n\n\n<p>Article 4 \u2013 Quality System, audit, and access to protocols<\/p>\n\n\n\n<p>4.1 The contractor guarantees that it has established a quality system suitable for the activities it performs. This quality assurance system, which complies with the requirements of the Guide to Good Compounding Practices, is described in its Quality Manual. The contractor undertakes to have at least one preparation of each type referred to in Article 2 tested annually by a recognized laboratory.<\/p>\n\n\n\n<p>4.2 The applicant shall have the right to audit the contractor\u2019s quality system and to determine the conditions under which such audit is conducted.<\/p>\n\n\n\n<p>4.3 The applicant shall have the right, upon simple request, to consult the protocols of the preparations it has delegated, following receipt of each preparation, for a period of ten (10) years from the date of receipt.<\/p>\n\n\n\n<p>Article 5 \u2013 Delegation of the preparation<\/p>\n\n\n\n<p>5.1 Obligations of the applicant<br>For each delegation, the applicant shall provide the following information to the contractor via the designated ordering platform:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>The identity of the applicant, including name, pharmacy address, and telephone number or e-mail address;<\/li>\n\n\n\n<li>The date of the request;<\/li>\n\n\n\n<li>The type of preparation, its qualitative and quantitative composition, and the volume or number of units to be prepared;<\/li>\n\n\n\n<li>The reference number assigned to the prescription for the magistral preparation.<\/li>\n<\/ol>\n\n\n\n<p>The applicant shall also provide any patient information necessary for the preparation (e.g., infant\/child\/adult, allergies to specific substances, etc.).<\/p>\n\n\n\n<p>5.2 Obligations of the contractor<br>5.2.1 The contractor shall perform the preparation as requested by the applicant in accordance with the Guide to Good Compounding Practices.<br>5.2.2 The contractor shall select the packaging in which the preparation is delivered.<br>5.2.3 The contractor shall comply with the storage conditions and shelf-life assigned to the preparation based on the Magistral Therapeutic Formulary (TMF).<br>5.2.4 The contractor shall conduct quality controls on the preparations and evaluate the results. Upon simple request by the applicant, the contractor shall provide evidence of such controls.<br>5.2.5 If the contractor deems it necessary to modify the formula of the delegated preparation, the contractor shall inform the applicant in advance and may implement the requested modification only with the applicant\u2019s written consent.<br>5.2.6 The contractor shall attach to the preparation a document sent to the applicant, containing at minimum the following information, based on the data submitted via the designated ordering platform:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>The identity of the applicant;<\/li>\n\n\n\n<li>The full qualitative and quantitative composition of the delegated preparation, as well as the prepared volume or quantity;<\/li>\n\n\n\n<li>The reference number assigned by the applicant;<\/li>\n\n\n\n<li>The reference number assigned by the contractor;<\/li>\n\n\n\n<li>The date of execution of the preparation, the storage conditions, and its expiration date;<\/li>\n\n\n\n<li>The weighing record;<\/li>\n\n\n\n<li>The controls performed on the preparation, with their results.<\/li>\n<\/ol>\n\n\n\n<p>5.2.7 The contractor shall indicate the following information on the packaging:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The reference number assigned to the prescription;<\/li>\n\n\n\n<li>The reference number assigned by the contractor;<\/li>\n\n\n\n<li>The expiration date;<\/li>\n\n\n\n<li>Any information deemed necessary for proper storage and handling of the preparation.<\/li>\n<\/ul>\n\n\n\n<p>Article 6 \u2013 Delivery and transport<\/p>\n\n\n\n<p>6.1 Delivery period<\/p>\n\n\n\n<p>6.1.1. Except in cases of force majeure, the contractor shall deliver the outsourced preparation no later than the business day following the delegation, provided that the order has been placed and confirmed through the designated ordering platform on a business day before 10 a.m.&nbsp;<\/p>\n\n\n\n<p>6.1.2. Neither party shall be liable to the other party for any delay in the performance or non-performance of its obligations under this agreement if this is the result of force majeure, provided that the party concerned immediately informs the other party in writing of the cause of the delay or non-performance, as well as the expected duration of that delay or non-performance.<\/p>\n\n\n\n<p>6.1.3. Once preparation has commenced, cancellation shall no longer be possible without incurring costs.<\/p>\n\n\n\n<p>6.1.4. If the delegated preparation contains products listed in Annexes I, II and IV of the Royal Decree of 6 September 2017 regulating narcotic drugs and psychotropic substances, preparation may only commence once the obligations of Article 7 have been fulfilled.<\/p>\n\n\n\n<p>6.2 Delivery terms<\/p>\n\n\n\n<p>6.2.1. The contractor shall deliver the outsourced preparation personally to the applicant.<\/p>\n\n\n\n<p>6.2.2 The contractor may, under its own responsibility, delegate the handover to a member of the pharmacy team, a courier service, or a wholesaler-distributor. The contractor shall inform the applicant of the chosen method of delivery at the time of ordering.<\/p>\n\n\n\n<p>Article 7 \u2013 Narcotics vouchers<br>If the delegated preparation contains products listed in Annexes I, II, and IV of the Royal Decree of 6 September 2017 regulating narcotic drugs and psychotropic substances, the narcotics voucher must be complied with: both the applicant and the contractor shall each separately record the declaration of, respectively, receipt and delivery in the Narcoreg web application.<\/p>\n\n\n\n<p>Article 8 \u2013 Dispensing of the outsourced preparation<\/p>\n\n\n\n<p>8.1 The applicant undertakes to inform the patient that the preparation has been outsourced.<\/p>\n\n\n\n<p>8.2 The applicant shall be responsible for affixing the label, which must contain the following information:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The name of the patient or the person responsible for the animals;<\/li>\n\n\n\n<li>The expiration date;<\/li>\n\n\n\n<li>Where applicable, the dosage of the preparation.<\/li>\n<\/ul>\n\n\n\n<p>8.3 The applicant shall ensure the dispensing of the preparation, the provision of pharmaceutical care, and the follow-up thereof.<\/p>\n\n\n\n<p>Article 9 \u2013 Invoicing and payment<\/p>\n\n\n\n<p>9.1 The following has been agreed:<\/p>\n\n\n\n<p>The rates displayed on the ordering platform shall be binding. By placing an order through the platform, the applicant agrees to the proposed rate. For formulas that are not yet included in the ordering platform, the price will be calculated manually and communicated to the applicant. Once the applicant has agreed to the price, the order will be accepted. Prices may be adjusted periodically on the ordering platform, depending on factors such as changes in raw material prices.<\/p>\n\n\n\n<p>9.2 These amounts are exclusive of VAT.<\/p>\n\n\n\n<p>9.3 The invoice shall be payable within fourteen (14) days from the invoice date.<\/p>\n\n\n\n<p>Article 10 \u2013 Duration of the agreement<\/p>\n\n\n\n<p>10.1 This agreement shall enter into force on the date of signature by both parties and shall remain in effect for an indefinite period.<\/p>\n\n\n\n<p>10.2 Either party may terminate this agreement subject to a notice period of three (3) months. Such notice may be given by any means of communication, provided that it is made in writing and with acknowledgment of receipt. The provisions of this agreement shall, however, remain applicable to all orders placed during its term of validity.<\/p>\n\n\n\n<p>10.3 This agreement shall automatically terminate:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>In the event of bankruptcy, suspension of payments, judicial liquidation of either Party, or, more generally, any event that seriously endangers the existence of either party;<\/li>\n\n\n\n<li>In the event of the contractor\u2019s failure to comply with Article 3 of this agreement;<\/li>\n\n\n\n<li>If the contractor\u2019s authorization is no longer wholly or partially valid.<\/li>\n<\/ul>\n\n\n\n<p>Article 11 \u2013 Protection of privacy<\/p>\n\n\n\n<p>11.1. Both the applicant and the contractor undertake to comply with the General Data Protection Regulation (GDPR).<\/p>\n\n\n\n<p>11.2. The applicant may not disclose to the contractor the identity of the patient for whom the preparation is intended or that of the prescribing doctor or dentist.<\/p>\n\n\n\n<p>Article 12 \u2013 Miscellaneous provisions<\/p>\n\n\n\n<p>12.1. The possible total or partial invalidity, illegality or inapplicability of any clause of this agreement shall not affect the validity, legality or applicability of the other clauses of this agreement and, if applicable, the parties shall negotiate in good faith a valid, legal and applicable replacement clause that approximates as closely as possible the rights and obligations in the clause to be replaced.<\/p>\n\n\n\n<p>12.2. Amendments or modifications to this agreement shall only be valid if they have been agreed in writing and signed by both parties.<\/p>\n\n\n\n<p>12.3. The parties undertake to resolve any dispute concerning the application or interpretation of this agreement amicably.<\/p>\n\n\n\n<p>12.4 This agreement is governed by Belgian law. Only the courts of the district of Ghent shall have jurisdiction over any disputes and\/or interpretation relating to this agreement.<\/p>\n<\/details>\n\n\n\n<p><\/p>\n\n\n\n<details class=\"wp-block-details\"><summary><strong><mark style=\"background-color:rgba(0, 0, 0, 0);color:#e6352b\" class=\"has-inline-color is-layout-flow wp-block-details-is-layout-flow\">&gt; Agreement regarding the outsourcing to compounding pharmacy Infinity Pharma (NL)<\/mark><\/strong><\/summary>\n<p><\/p>\n\n\n\n<p><strong>Definitions:<\/strong><\/p>\n\n\n\n<p><em>Infinity Pharma<\/em>: The private limited liability company Pharmaline B.V., (trade name:<em> Infinity Pharma<\/em>) located in Oldenzaal (7575 ED) at M\u00fcnsterstraat 4, legally represented by registered pharmacist R.G.M. Goossen.<\/p>\n\n\n\n<p><em>Parties<\/em>: The <em>applicant <\/em>and <em>Infinity Pharma<\/em>.<\/p>\n\n\n\n<p><strong>Considerations<\/strong><\/p>\n\n\n\n<p>The Parties intend to establish a collaboration regarding the supply of products (provided by <em>Infinity Pharma<\/em>).<\/p>\n\n\n\n<p><strong>1. Ordering Process<\/strong><\/p>\n\n\n\n<p><strong>1.1<\/strong> The department\/clinic shall submit its orders to the <em>applicant<\/em> by means of a prescription for the product, issued in the name of the clinic, with the dosage indicated as \u201cIMM\u201d (In Manu Medici; meaning that the product is to be placed directly in the hands of the physician).<br><strong>1.2<\/strong> The <em>applicant<\/em> shall forward the prescription, as received from the department\/clinic, to <em>Infinity Pharma<\/em> (assistent@infinitypharma.com).<\/p>\n\n\n\n<p><strong>2. Delivery<\/strong><\/p>\n\n\n\n<p><strong>2.1<\/strong> <em>Infinity Pharma<\/em> shall supply the products to the department\/clinic and deliver them, based on the prescription, to the <em>applicant<\/em>.<br><strong>2.2<\/strong> Delivery to the department\/clinic shall be subcontracted by <em>Infinity Pharma<\/em> to the <em>applicant<\/em>.<\/p>\n\n\n\n<p><strong>3. Invoicing<\/strong><\/p>\n\n\n\n<p><strong>3.1<\/strong> Invoicing to the department\/clinic shall be subcontracted by <em>Infinity Pharma<\/em> to the <em>applicant<\/em>.<br><strong>3.2<\/strong> <em>Infinity Pharma<\/em> shall invoice the <em>applicant<\/em> for the services and products supplied.<\/p>\n\n\n\n<p><strong>4. Commercial Terms<\/strong><\/p>\n\n\n\n<p><strong>4.1<\/strong> For the supplied products, the Parties shall agree on a price per product.<\/p>\n<\/details>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Click on the individual agreement to view the text.<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-74047","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/pages\/74047","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/comments?post=74047"}],"version-history":[{"count":12,"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/pages\/74047\/revisions"}],"predecessor-version":[{"id":96773,"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/pages\/74047\/revisions\/96773"}],"wp:attachment":[{"href":"https:\/\/fagroncompoundingservices.be\/en\/wp-json\/wp\/v2\/media?parent=74047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}