Guidance for Compounding Pharmacies Considering the BioG MicroTabs System
Ralph Fucetola JD
MEMORANDUM
Private & confidential …
To: Interested Compounding Pharmacies
Date: April 21, 2012
Below are excerpts from the GMPs for Compounding Pharmacies using the ROEHR patented microtab system for dietary supplements and medical foods, to guide potential cooperating pharmacies. The GMP document guides the Compounding Pharmacies from receipt of the written recommendation from the physician or other practitioner through the mixing, labeling and shipping of the product. This excerpt is provided to allow Compounding Pharmacies to consider what space and equipment may be needed to most efficiently implement the Patented System.
More information about the patented system:
http://biog-microtabs.weebly.com/index.html
SOP #2: Receipt and Handling of the Microtablets
All microtablet ingredients are shipped in bulk, in individual containers, with desiccant packet. The ingredients may be shipped at ambient temperature and upon receipt are to be handled as packaged food ingredients. They are to be stored at room temperature in dry conditions. The CP is responsible for safely receiving, holding, protecting, processing and shipping the Inventory. The CP shall account in writing to the Company on a monthly or weekly basis, providing the [1] Current Inventory held, [2] Inventory Received, [3] Orders Processed, and [4] Orders Shipped.
SOP #3: Local Regulations
[A] The CP is required to meet all local food-processing legal standards, unless the CP is legally required to meet higher standards, in which case the higher standards shall prevail.
[B] Generally, since the micro-tablet products are made from dietary ingredients and will be mixed in the patented system only with other food grade ingredients, standard food GMPs apply.
SOP #4: The Patented Mixing Procedures
[A] Product is a food ingredient preparation based on BioG MicroTabs ( microtablets) with standard food grade handling and cGMPs, based on Federal Republic of Germany Patent No. 10 2006 006 532 (US Patent Application 2009/0175936 A1).
[B] Each BioG MicroTabs (microtablet) is of the same spatial shape (cylindrical, elliptical or spherical) and similar weight (though of different nutrient contents) to promote homogenous mixing. In the case of the BioG MicroTabs, the product has a uniform dimension of 2 x 2 mm and a uniform weight of 7 mg, +/- 10% variation.
[C] [a] To produce a homogenous mixture of the different BioG MicroTabs ingredients (microtablets), which weigh as above, a standard food grade mixer is recommended, preferably of glass or aluminum to avoid electrostatic loading. Mixing time will vary based on size and composition of the blend, with an average mixing time of [20-30 seconds]. Hand mixing in plastic mixing bag will also achieve homogeneity, if gentle hand mixing is continued for approximately 30-45 seconds].
[b] The final blend has to be then filled into a container and a food-grade desiccant packet has to be added.
[c] Both containers and desiccants will be exclusively supplied by ROEHR Pharmaceuticals
[d] In any case it is the responsibility of the pharmacist or other responsible person at the LP to make sure organoleptically that homogeneity is achieved.
[D] Preparation formulation shall consist of a homogenous mixture of at least 2 BioG MicroTabs (microtablets) nutrient ingredients.
[E] The CP shall purchase/provide (or ROEHR provide, at its discretion) all labeling, informational or advertising materials, glass jars, desiccants, plastic spoons, and other necessary materials and equipment needed to use the Patented System exclusively from RPLLC. The CP shall not purchase mico-tab nutrients from any source other than RPLLC and shall inform RPLLC in writing of any offer to provide received for such nutrient products.
SOP #5: Labeling Requirements
[A] The required labeling varies based on the intended use. Final preparation to be labeled as a Medical Food or as a Dietary Supplement depending on indications for which the preparation is recommended by the health care professional or pharmacist, within the scope of practice thereof.
[B] The labeling to be included for premixed formulas, provided by the Company or the CP, shall be similarly either for Medical Food or Dietary Supplement.
[C] All labels and literature will include, in addition to the name of the pharmacy, a copy of the ROEHR Logo and the statement: "Licensed ROEHR BioG MicroTabs ingredients and patented MicroTab mixing technology.”
[D] Formats for the two label varieties are attached as Exhibits A and B [to the GMPs].
© 2012 ROEHR Pharmaceuticals
MEMORANDUM
Private & confidential …
To: Interested Compounding Pharmacies
Date: April 21, 2012
Below are excerpts from the GMPs for Compounding Pharmacies using the ROEHR patented microtab system for dietary supplements and medical foods, to guide potential cooperating pharmacies. The GMP document guides the Compounding Pharmacies from receipt of the written recommendation from the physician or other practitioner through the mixing, labeling and shipping of the product. This excerpt is provided to allow Compounding Pharmacies to consider what space and equipment may be needed to most efficiently implement the Patented System.
More information about the patented system:
http://biog-microtabs.weebly.com/index.html
SOP #2: Receipt and Handling of the Microtablets
All microtablet ingredients are shipped in bulk, in individual containers, with desiccant packet. The ingredients may be shipped at ambient temperature and upon receipt are to be handled as packaged food ingredients. They are to be stored at room temperature in dry conditions. The CP is responsible for safely receiving, holding, protecting, processing and shipping the Inventory. The CP shall account in writing to the Company on a monthly or weekly basis, providing the [1] Current Inventory held, [2] Inventory Received, [3] Orders Processed, and [4] Orders Shipped.
SOP #3: Local Regulations
[A] The CP is required to meet all local food-processing legal standards, unless the CP is legally required to meet higher standards, in which case the higher standards shall prevail.
[B] Generally, since the micro-tablet products are made from dietary ingredients and will be mixed in the patented system only with other food grade ingredients, standard food GMPs apply.
SOP #4: The Patented Mixing Procedures
[A] Product is a food ingredient preparation based on BioG MicroTabs ( microtablets) with standard food grade handling and cGMPs, based on Federal Republic of Germany Patent No. 10 2006 006 532 (US Patent Application 2009/0175936 A1).
[B] Each BioG MicroTabs (microtablet) is of the same spatial shape (cylindrical, elliptical or spherical) and similar weight (though of different nutrient contents) to promote homogenous mixing. In the case of the BioG MicroTabs, the product has a uniform dimension of 2 x 2 mm and a uniform weight of 7 mg, +/- 10% variation.
[C] [a] To produce a homogenous mixture of the different BioG MicroTabs ingredients (microtablets), which weigh as above, a standard food grade mixer is recommended, preferably of glass or aluminum to avoid electrostatic loading. Mixing time will vary based on size and composition of the blend, with an average mixing time of [20-30 seconds]. Hand mixing in plastic mixing bag will also achieve homogeneity, if gentle hand mixing is continued for approximately 30-45 seconds].
[b] The final blend has to be then filled into a container and a food-grade desiccant packet has to be added.
[c] Both containers and desiccants will be exclusively supplied by ROEHR Pharmaceuticals
[d] In any case it is the responsibility of the pharmacist or other responsible person at the LP to make sure organoleptically that homogeneity is achieved.
[D] Preparation formulation shall consist of a homogenous mixture of at least 2 BioG MicroTabs (microtablets) nutrient ingredients.
[E] The CP shall purchase/provide (or ROEHR provide, at its discretion) all labeling, informational or advertising materials, glass jars, desiccants, plastic spoons, and other necessary materials and equipment needed to use the Patented System exclusively from RPLLC. The CP shall not purchase mico-tab nutrients from any source other than RPLLC and shall inform RPLLC in writing of any offer to provide received for such nutrient products.
SOP #5: Labeling Requirements
[A] The required labeling varies based on the intended use. Final preparation to be labeled as a Medical Food or as a Dietary Supplement depending on indications for which the preparation is recommended by the health care professional or pharmacist, within the scope of practice thereof.
[B] The labeling to be included for premixed formulas, provided by the Company or the CP, shall be similarly either for Medical Food or Dietary Supplement.
[C] All labels and literature will include, in addition to the name of the pharmacy, a copy of the ROEHR Logo and the statement: "Licensed ROEHR BioG MicroTabs ingredients and patented MicroTab mixing technology.”
[D] Formats for the two label varieties are attached as Exhibits A and B [to the GMPs].
© 2012 ROEHR Pharmaceuticals