Standard Pharmaceutical Product Information (Rx Product Only)

Transcription

1 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: New Item Final Version Date: Company Name: AuroMedics Pharma LLC Application: ANDA a. Temperature Indicate the USP temperature range for this product. Application Number for NDA/ANDA/BLA, Med Device: I. Freezer between -25 and -10 C ( F) DUNS: II. Cold between 2 and 8 C (36 46 F) Rx Product/Proprietary Name: Levetiracetam in 0.82% Sodium Chloride injection for intravenous Infusion only 500mg/100mL(5mg/mL) III. Cool between 8 and 15 C (46 59 F) NDC: UPC: IV. Controlled Room between 20 and 25 C (68 77 F) CVX Code: MVX Code: allows for excursions between 15 and 30 C (59 86 F) Description: Levetiracetam in 0.82% Sodium Chloride injection for intravenous Infusion only 500mg/100mL(5mg/mL) V. Avoid Excessive Heat above 40 C (>104 F) YES VI. Other Temperature Range Requirement Active ingredients: (write in) Recommended storage: At or below 25 C VII. Requirement URL for Additional Product Information: Address: 6 Wheeling Road Address 2: b. Contact for temperature excursion questions: City: Dayton State: NJ Zip: Name: Steve Lucas Key Contact: Number: Phone Number: Fax: Is this product to be shipped to customers on ice? I. Orange Book Rating: AP II. Brand Name: Keppra III. Generic Equivalent for Brand: levetiracetam c. Special regulations for product in certain states? Does supplier meet DSCSA definition of manufacturer? Yes Special returns requirements for this product? Is product exempt from DSCSA? d. Store product (unit of sale) upright? If yes, select exemption: Protect product (unit of sale) from light? Other exemption - Write in: Is product repackaged? If Yes, was original product purchased direct from mfr? e. Shelf life: 24 Months Is product sold by manufacturer's exclusive distributor? Initial shelf life at launch (if different): Months Are any waivers granted for product ID/barcode? If yes, attach documentation from FDA Is the Product Direct Ship Item ORDER INFORMATION Dimensions (US msmts.) Weight Lbs. Legend Device? Unit of Sale What is the NDC selling unit? Depth Height Width: State Control? Bottle 10 's of single use flexible containers in one ARCOS reportable? Box/Carton case pack. The Case pack NDC. is Item: Co-Licensed? Ampule (Write-in, e.g. 1 Box of 10 Vials) Box/ ( ( ( (1 Triple Controlled Substance? Glass Carton: Triple Triple Triple Laminated Schedule.? Tube Minimum order quantity? Yes (incl. N for non-narcotic) Vial Liquid Sgl Case: Controlled Substance Code: Vial Liquid Multi If Yes, how many of which package type? Pallet: Hazardous Material/Cytotoxic Agent? Vial Powder Sql 10 Each Vial Power Multi 1 Inner/Carton/Pack Case: UPC: Is Item... x Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for SD infusion bag hospital scanning? Is it reverse numbered? PRODUCT INFORMATION FOR GENERIC DRUG PRODUCTS DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION ADDITIOL PRODUCT INFORMATION PHARMACY ORDER / BILL UNIT Rec. sell unit to customer? Other Product Information Size/Strength/Form: WHOLESALER USE ONLY: (Write-in, e.g. 1 Vial) Product Shape: Vendor #: Rx billing unit to pharmacy: Product Color: $ Whsl. Code #: Each Fineline Code: Gram Product Imprint: Milliliter As of date: 1/5/2017 *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature: Is this product to be shipped to customers on dry ice? (For Regular Cost Per Unit of Sale ($) ITEM AND PACKING INFORMATION (For Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE. SPECIAL HANDLING AND STORAGE REQUIREMENTS* 40 COST INFORMATION Invoice Cost (WAC) ($) Volume (Cube) # Pieces: 1 Triple Laminated Case (10 Triple For Sea (80 Shippers or Federal Excise Tax Per Unit of Sale

2 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Carcinogen Reproductive Toxicant Both Warning appears on label c. Contact Hazard? d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) e. Does the product contain DEHP? For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification EPA Hazardous Waste Code: Is this product regulated for shipment by the DOT? Is this a reportable quantity? RQ Threshold: Is this a marine pollutant? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) (if yes, answer a-d below and provide SDS) a. DOT Hazard Class b. UN/ID Number c. Packing Group d. Inhalation Hazard? Limited Quantity ADDITIOL PRODUCT INFORMATION - Serialization Consumer Commodity, ORM-D Level How? Small Quantity (49 CFR 173.4) Serialized? Item 2D Linear RFID Special Permit; DOT-SP If not, when? Box/Carton 2D Linear RFID Special Provision (listed in Column 7 of 49 CFR ); Items aggregated to case? Case 2D Linear RFID SP# Pallet 2D Linear RFID GTIN Is the product restricted for air shipment? If so, indicate restriction: Passenger Is there a REMS on this product? Cargo If Yes, is it managed with a pharmacy registry? Passenger & Cargo Website URL: Please check as appropriate for this product. Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Comments / Details: (For example, ipledge program?) Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS Contact tel. # if product received damaged: Is product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Pseudoephedrine Phenylpropanolamine Iodine ( 2.2%) Other: Restricted to hospital, clinics, and physician offices only: Restricted from US territories? (explain in comments) ADD'L STORAGE INFORMATION CLASS OF TRADE RESTRICTION: If Unit Dose NDC, indicate NDC here: REMS or REGISTRY RESTRICTIONS ADDITIOL INFORMATION MISCELLANEOUS NOTES and/or Image of Product Barcode: Release DATE

3 Standard Pharmaceutical Product Information (Page 3) Purchase orders may be accepted by: Purchase order daily receipt cut off time by supplier a. EDI Cut off time: b. Autofax Fax Number: c. Fax Fax Number: Shipping lead time of PO: Hours Days d. Phone only Phone.: e. Supplier Web Site only Site Address: Ships same day for next day receipt: Minimum Order Quantity: Ships for second day receipt: Supplier's Customer Service Number: Ships regular ground for 3-10 days receipt: Contracted 3PL company / contact #: Name: Phone: Expedited freight fees billed with each order: Drop Ship service fee billed with each order: Overnight receipt available: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Tuesday Wednesday Thursday Friday Saturday Overnight receipt available: Restricted to hospital, clinics, and physician offices only: Phone: Phone #: Order receipt method: Restricted from US territories? (explain in comments) Fax: Fax #: EDI: Overnight Fees apply: Other fees apply: REMS: Contact # if product is received damaged: REMS Program Manager Name: Phone: Is product returnable for credit: Supplier Manages REMS registry exclusively: URL/Link to returns policy: Wholesale distributor support: Provider Name: Site Enrollment Number assigned by Supplier: DEA #: PCPDP #: NPI #: Registry: ADDITIOL INFORMATION Registry Program Contact Name: Phone: Is product order for scheduled patient procedure? Comments Is product order for restocking purposes? Patient Procedure Date: Physician Name: Physician/Clinic Phone # Physician State License # Physician/Clinic DEA #: Physician/Clinic Specialty: FOR DESIGTED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete. Order Method for Designated Drop Ship Product Standard Order Receipt and Processing Expedited Freight Charges or Other Designated Drop Ship Fees: Class of Trade Restriction: REMS or Registry Restrictions Other Data Information Required to Process PO: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Miscellaneous tes:

4 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: New Item Final Version Date: Company Name: AuroMedics Pharma LLC Application: ANDA a. Temperature Indicate the USP temperature range for this product. Application Number for NDA/ANDA/BLA, Med Device: I. Freezer between -25 and -10 C ( F) DUNS: II. Cold between 2 and 8 C (36 46 F) Rx Product/Proprietary Name: Levetiracetam in 0.75% Sodium Chloride injection for intravenous Infusion only 1000mg/100mL(10mg/mL) III. Cool between 8 and 15 C (46 59 F) NDC: UPC: IV. Controlled Room between 20 and 25 C (68 77 F) CVX Code: MVX Code: allows for excursions between 15 and 30 C (59 86 F) Description: Levetiracetam in 0.75% Sodium Chloride injection for intravenous Infusion only 1000mg/100mL(10mg/mL) V. Avoid Excessive Heat above 40 C (>104 F) YES VI. Other Temperature Range Requirement Active ingredients: (write in) Recommended storage: At or below 25 C VII. Requirement URL for Additional Product Information: Address: 6 Wheeling Road Address 2: b. Contact for temperature excursion questions: City: Dayton State: NJ Zip: Name: Steve Lucas Key Contact: Number: Phone Number: Fax: Is this product to be shipped to customers on ice? I. Orange Book Rating: AP II. Brand Name: Keppra III. Generic Equivalent for Brand: levetiracetam c. Special regulations for product in certain states? Does supplier meet DSCSA definition of manufacturer? Yes Special returns requirements for this product? Is product exempt from DSCSA? d. Store product (unit of sale) upright? If yes, select exemption: Protect product (unit of sale) from light? Other exemption - Write in: Is product repackaged? If Yes, was original product purchased direct from mfr? e. Shelf life: 24 Months Is product sold by manufacturer's exclusive distributor? Initial shelf life at launch (if different): Months Are any waivers granted for product ID/barcode? If yes, attach documentation from FDA Is the Product Direct Ship Item ORDER INFORMATION Dimensions (US msmts.) Weight Lbs. Legend Device? Unit of Sale What is the NDC selling unit? Depth Height Width: State Control? Bottle 10 's of single use flexible containers in one ARCOS reportable? Box/Carton case pack. The Case pack NDC. is Item: Co-Licensed? Ampule (Write-in, e.g. 1 Box of 10 Vials) Box/ ( ( ( (1 Triple Controlled Substance? Glass Carton: Triple Triple Triple Laminated Schedule.? Tube Minimum order quantity? Yes (incl. N for non-narcotic) Vial Liquid Sgl Case: Is it reverse numbered? PRODUCT INFORMATION FOR GENERIC DRUG PRODUCTS DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION ADDITIOL PRODUCT INFORMATION Controlled Substance Code: Vial Liquid Multi If Yes, how many of which package type? Pallet: Hazardous Material/Cytotoxic Agent? Vial Powder Sql 10 Each Vial Power Multi 1 Inner/Carton/Pack Case: UPC: Is Item... x Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for SD infusion bag hospital scanning? PHARMACY ORDER / BILL UNIT Rec. sell unit to customer? Other Product Information Size/Strength/Form: (For WHOLESALER USE ONLY: (Write-in, e.g. 1 Vial) Product Shape: Vendor #: Rx billing unit to pharmacy: Product Color: $ Whsl. Code #: Each Fineline Code: Gram Product Imprint: Milliliter As of date: 1/5/2017 *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature: SPECIAL HANDLING AND STORAGE REQUIREMENTS* Is this product to be shipped to customers on dry ice? ITEM AND PACKING INFORMATION (For Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE Regular Cost Per Unit of Sale ($) 40 COST INFORMATION Invoice Cost (WAC) ($) Volume (Cube) # Pieces: 1 Triple Laminated Case (10 Triple For Sea (80 Shippers or Federal Excise Tax Per Unit of Sale

5 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Carcinogen Reproductive Toxicant Both Warning appears on label c. Contact Hazard? d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) e. Does the product contain DEHP? For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification EPA Hazardous Waste Code: Is this product regulated for shipment by the DOT? Is this a reportable quantity? RQ Threshold: Is this a marine pollutant? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) (if yes, answer a-d below and provide SDS) a. DOT Hazard Class b. UN/ID Number c. Packing Group d. Inhalation Hazard? Limited Quantity ADDITIOL PRODUCT INFORMATION - Serialization Consumer Commodity, ORM-D Level How? Small Quantity (49 CFR 173.4) Serialized? Item 2D Linear RFID Special Permit; DOT-SP If not, when? Box/Carton 2D Linear RFID Special Provision (listed in Column 7 of 49 CFR ); Items aggregated to case? Case 2D Linear RFID SP# Pallet 2D Linear RFID GTIN Is the product restricted for air shipment? If so, indicate restriction: Passenger Is there a REMS on this product? Cargo If Yes, is it managed with a pharmacy registry? Passenger & Cargo Website URL: Please check as appropriate for this product. Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Comments / Details: (For example, ipledge program?) Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS Contact tel. # if product received damaged: Is product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Pseudoephedrine Phenylpropanolamine Iodine ( 2.2%) Other: Restricted to hospital, clinics, and physician offices only: Restricted from US territories? (explain in comments) ADD'L STORAGE INFORMATION CLASS OF TRADE RESTRICTION: If Unit Dose NDC, indicate NDC here: REMS or REGISTRY RESTRICTIONS ADDITIOL INFORMATION MISCELLANEOUS NOTES and/or Image of Product Barcode: Release DATE

6 Standard Pharmaceutical Product Information (Page 3) Purchase orders may be accepted by: Purchase order daily receipt cut off time by supplier a. EDI Cut off time: b. Autofax Fax Number: c. Fax Fax Number: Shipping lead time of PO: Hours Days d. Phone only Phone.: e. Supplier Web Site only Site Address: Ships same day for next day receipt: Minimum Order Quantity: Ships for second day receipt: Supplier's Customer Service Number: Ships regular ground for 3-10 days receipt: Contracted 3PL company / contact #: Name: Phone: Expedited freight fees billed with each order: Drop Ship service fee billed with each order: Overnight receipt available: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Tuesday Wednesday Thursday Friday Saturday Overnight receipt available: Restricted to hospital, clinics, and physician offices only: Phone: Phone #: Order receipt method: Restricted from US territories? (explain in comments) Fax: Fax #: EDI: Overnight Fees apply: Other fees apply: REMS: Contact # if product is received damaged: REMS Program Manager Name: Phone: Is product returnable for credit: Supplier Manages REMS registry exclusively: URL/Link to returns policy: Wholesale distributor support: Provider Name: Site Enrollment Number assigned by Supplier: DEA #: PCPDP #: NPI #: Registry: ADDITIOL INFORMATION Registry Program Contact Name: Phone: Is product order for scheduled patient procedure? Comments Is product order for restocking purposes? Patient Procedure Date: Physician Name: Physician/Clinic Phone # Physician State License # Physician/Clinic DEA #: Physician/Clinic Specialty: FOR DESIGTED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete. Order Method for Designated Drop Ship Product Standard Order Receipt and Processing Expedited Freight Charges or Other Designated Drop Ship Fees: Class of Trade Restriction: REMS or Registry Restrictions Other Data Information Required to Process PO: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Miscellaneous tes:

7 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Introduction Type: New Item Final Version Date: Company Name: AuroMedics Pharma LLC Application: ANDA a. Temperature Indicate the USP temperature range for this product. Application Number for NDA/ANDA/BLA, Med Device: I. Freezer between -25 and -10 C ( F) DUNS: II. Cold between 2 and 8 C (36 46 F) Rx Product/Proprietary Name: Levetiracetam in 0.54% Sodium Chloride injection for intravenous Infusion only 1500mg/100mL (15mg/mL) III. Cool between 8 and 15 C (46 59 F) NDC: UPC: IV. Controlled Room between 20 and 25 C (68 77 F) CVX Code: MVX Code: allows for excursions between 15 and 30 C (59 86 F) Description: Levetiracetam in 0.54% Sodium Chloride injection for intravenous Infusion only 1500mg/100mL (15mg/mL) V. Avoid Excessive Heat above 40 C (>104 F) YES VI. Other Temperature Range Requirement Active ingredients: (write in) Recommended storage: At or below 25 C VII. Requirement URL for Additional Product Information: Address: 6 Wheeling Road Address 2: b. Contact for temperature excursion questions: City: Dayton State: NJ Zip: Name: Steve Lucas Key Contact: Number: Phone Number: Fax: Is this product to be shipped to customers on ice? I. Orange Book Rating: AP II. Brand Name: Keppra III. Generic Equivalent for Brand: levetiracetam c. Special regulations for product in certain states? Does supplier meet DSCSA definition of manufacturer? Yes Special returns requirements for this product? Is product exempt from DSCSA? d. Store product (unit of sale) upright? If yes, select exemption: Protect product (unit of sale) from light? Other exemption - Write in: Is product repackaged? If Yes, was original product purchased direct from mfr? e. Shelf life: 24 Months Is product sold by manufacturer's exclusive distributor? Initial shelf life at launch (if different): Months Are any waivers granted for product ID/barcode? If yes, attach documentation from FDA Is the Product Direct Ship Item ORDER INFORMATION Dimensions (US msmts.) Weight Lbs. Legend Device? Unit of Sale What is the NDC selling unit? Depth Height Width: State Control? Bottle 10 's of single use flexible containers in one ARCOS reportable? Box/Carton case pack. The Case pack NDC. is Item: Co-Licensed? Ampule (Write-in, e.g. 1 Box of 10 Vials) Box/ ( ( ( (1 Triple Controlled Substance? Glass Carton: Triple Triple Triple Laminated Schedule.? Tube Minimum order quantity? Yes (incl. N for non-narcotic) Vial Liquid Sgl Case: Is it reverse numbered? PRODUCT INFORMATION FOR GENERIC DRUG PRODUCTS DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION ADDITIOL PRODUCT INFORMATION Controlled Substance Code: Vial Liquid Multi If Yes, how many of which package type? Pallet: Hazardous Material/Cytotoxic Agent? Vial Powder Sql 10 Each Vial Power Multi 1 Inner/Carton/Pack Case: UPC: Is Item... x Other: Write In 1 Case Carton: If Unit Dose, is item bar coded to unit dose for SD infusion bag hospital scanning? PHARMACY ORDER / BILL UNIT Rec. sell unit to customer? Other Product Information Size/Strength/Form: (For WHOLESALER USE ONLY: (Write-in, e.g. 1 Vial) Product Shape: Vendor #: Rx billing unit to pharmacy: Product Color: $ Whsl. Code #: Each Fineline Code: Gram Product Imprint: Milliliter As of date: 1/5/2017 *Please provide any additional information on page 2. See new p. 3 for Designated Drop Ship Only. Signature: SPECIAL HANDLING AND STORAGE REQUIREMENTS* Is this product to be shipped to customers on dry ice? ITEM AND PACKING INFORMATION (For Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE Regular Cost Per Unit of Sale ($) 40 COST INFORMATION Invoice Cost (WAC) ($) Volume (Cube) # Pieces: 1 Triple Laminated Case (10 Triple For Sea (80 Shippers or Federal Excise Tax Per Unit of Sale

8 Standard Pharmaceutical Product Information (Page 2) Is this product (check all that apply): a. Cytotoxic? b. CA Prop. 65 Carcinogen or Reproductive Toxicant? Carcinogen Reproductive Toxicant Both Warning appears on label c. Contact Hazard? d. Does this product require special clean-up instructions? (If yes, attach SDS with special instructions.) e. Does the product contain DEHP? For Designated Drop Ship Only Products, Please Use Page 3 MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION Hazardous Waste Identification EPA Hazardous Waste Code: Is this product regulated for shipment by the DOT? Is this a reportable quantity? RQ Threshold: Is this a marine pollutant? Is this product shipped utilizing an authorized DOT exception or Special Permit? (if yes, identify method below) (if yes, answer a-d below and provide SDS) a. DOT Hazard Class b. UN/ID Number c. Packing Group d. Inhalation Hazard? Limited Quantity ADDITIOL PRODUCT INFORMATION - Serialization Consumer Commodity, ORM-D Level How? Small Quantity (49 CFR 173.4) Serialized? Item 2D Linear RFID Special Permit; DOT-SP If not, when? Box/Carton 2D Linear RFID Special Provision (listed in Column 7 of 49 CFR ); Items aggregated to case? Case 2D Linear RFID SP# Pallet 2D Linear RFID GTIN Is the product restricted for air shipment? If so, indicate restriction: Passenger Is there a REMS on this product? Cargo If Yes, is it managed with a pharmacy registry? Passenger & Cargo Website URL: Please check as appropriate for this product. Organic Inorganic Antineoplastic Steroid/Androgen Corrosive Oxidizer Comments / Details: (For example, ipledge program?) Aerosol Class; Identify NFPA Storage Level: RETURN INSTRUCTIONS Contact tel. # if product received damaged: Is product returnable for credit: Listed Chemical (List I or II) (Indicate or Write-in below): URL/Link to returns policy: Ephedrine Pseudoephedrine Phenylpropanolamine Iodine ( 2.2%) Other: Restricted to hospital, clinics, and physician offices only: Restricted from US territories? (explain in comments) ADD'L STORAGE INFORMATION CLASS OF TRADE RESTRICTION: If Unit Dose NDC, indicate NDC here: REMS or REGISTRY RESTRICTIONS ADDITIOL INFORMATION MISCELLANEOUS NOTES and/or Image of Product Barcode: Release DATE

9 Standard Pharmaceutical Product Information (Page 3) Purchase orders may be accepted by: Purchase order daily receipt cut off time by supplier a. EDI Cut off time: b. Autofax Fax Number: c. Fax Fax Number: Shipping lead time of PO: Hours Days d. Phone only Phone.: e. Supplier Web Site only Site Address: Ships same day for next day receipt: Minimum Order Quantity: Ships for second day receipt: Supplier's Customer Service Number: Ships regular ground for 3-10 days receipt: Contracted 3PL company / contact #: Name: Phone: Expedited freight fees billed with each order: Drop Ship service fee billed with each order: Overnight receipt available: PO Receipt cut off time: Drop Ship miscellaneous fees billed: Days of week overnight is available: Monday Tuesday Wednesday Thursday Friday Saturday Overnight receipt available: Restricted to hospital, clinics, and physician offices only: Phone: Phone #: Order receipt method: Restricted from US territories? (explain in comments) Fax: Fax #: EDI: Overnight Fees apply: Other fees apply: REMS: Contact # if product is received damaged: REMS Program Manager Name: Phone: Is product returnable for credit: Supplier Manages REMS registry exclusively: URL/Link to returns policy: Wholesale distributor support: Provider Name: Site Enrollment Number assigned by Supplier: DEA #: PCPDP #: NPI #: Registry: ADDITIOL INFORMATION Registry Program Contact Name: Phone: Is product order for scheduled patient procedure? Comments Is product order for restocking purposes? Patient Procedure Date: Physician Name: Physician/Clinic Phone # Physician State License # Physician/Clinic DEA #: Physician/Clinic Specialty: FOR DESIGTED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete. Order Method for Designated Drop Ship Product Standard Order Receipt and Processing Expedited Freight Charges or Other Designated Drop Ship Fees: Class of Trade Restriction: REMS or Registry Restrictions Other Data Information Required to Process PO: Priority Overnight receipt available: Overnight and Priority Overnight PO Processing Return Instructions Miscellaneous tes: