PAR STERILE PRODUCTS. Affordable Products. Quality You Can Trust. FEBRUARY 2016 PRODUCT CATALOG

Transcription

1 PAR STERILE PRODUCTS Affordable Products. Quality You Can Trust. FEBRUARY 2016 PRODUCT CATALOG

2 * Product Requires Refrigeration PF - Preservative Free Y - Yes ABC = AmerisourceBergen Adrenalin Injection epinephrine injection, USP mg/ml 3 ml SUV 1 ml C (68-77 F) Y Y and freezing mg/ml 36 ml MDV 30 ml C (68-77 F) N Y and freezing Adrenalin Chloride Solution for topical application epinephrine nasal solution, USP mg/ml 1 oz. vial 30 ml C (68-77 F) N Y and freezing * Aplisol tuberculin purified protein derivative, diluted TU/0.1 ml 3 ml MDV 1 ml C (36-46 F) N Y Do not freeze TU/0.1 ml 10 ml MDV 5 ml C (36-46 F) N Y Do not freeze 2

3 * Product Requires Refrigeration PF - Preservative Free Y - Yes ABC = AmerisourceBergen Argatroban Injection mg/2.5 ml 5 ml SDV 2.5 ml C (68-77 F) Y Y Do not freeze Brevital Sodium Lyophilized Powder for Injection methohexital sodium for injection, USP mg 50 ml MDV N/A C (68-77 F) Y Y g 50 ml MDV N/A C (68-77 F) Y Y Buprenorphine HCl Injection, mg/ml 3 ml SDV 1 ml C (68-77 F) Y Y Protect from prolonged exposure to light 3

4 ** Dantrium IV is a non-returnable product PF - Preservative Free Y - Yes ABC = AmerisourceBergen Colistimethate for Injection, USP Lyophilized Powder For Injection, USP mg 10 ml SDV N/A C (68-77 F) Y Y colistin base activity mg 10 ml SDV N/A C (68-77 F) Y Y colistin base activity Coly-Mycin M Lyophilized Powder for Injection colistimethate for injection, USP mg 10 ml SDV N/A C (68-77 F) Y Y colistin base activity mg 10 ml SDV N/A C (68-77 F) Y Y colistin base activity ** Dantrium Intravenous Lyophilized Powder for Injection dantrolene sodium for injection mg 70 ml SDV N/A C (68-77 F) Y Y dantrolene sodium 3000 mg mannitol Avoid prolonged exposure to light 4

5 PF - Preservative Free Y - Yes ABC = AmerisourceBergen N/A Not Applicable LF - Latex Free N - No M&D = Morris & Dickson Co. Dantrium Capsules dantrolene sodium, capsules mg N/A 100 Capsules 1 bottle C (68-77 F) Y Y mg N/A 100 Capsules 1 bottle C (68-77 F) Y Y Delestrogen estradiol valerate injection, USP mg/ml 5 ml MDV 5 ml C (68-77 F) N Y mg/ml 5 ml MDV 5 ml C (68-77 F) N Y mg/ml 5 ml MDV 5 ml C (68-77 F) N Y Dexmedetomidine HCl, Injection mcg/2 ml 3 ml SDV 2 ml C (68-77 F) Y Y

6 * Product Requires Refrigeration PF - Preservative Free Y - Yes ABC = AmerisourceBergen Ethacrynate Sodium for Injection, USP mg/vial 50 ml SDV N/A C (68-77 F) Y Y Fluphenazine Decanoate Injection, USP mg/ml 5 ml MDV 5 ml C (68-77 F) N Y Ketalar ketamine hydrochloride injection, USP mg/ml 20 ml MDV 20 ml C (68-77 F) N Y mg/ml 10 ml MDV 10 ml C (68-77 F) N Y mg/ml 5 ml MDV 5 ml C (68-77 F) N Y

7 * Product Requires Refrigeration PF - Preservative Free Y - Yes ABC = AmerisourceBergen Pitocin oxytocin injection, USP, synthetic units/ml 3 ml SDV 1 ml C (68-77 F) N Y units/ml 10 ml MDV 10 ml C (68-77 F) N Y units/ml 10 ml MDV 10 ml C (68-77 F) N Y units/ml 70 ml PBP 50 ml C (68-77 F) N Y (Pharmacy Bulk Pack) Tigan trimethobenzamide hydrochloride, injectable mg/ml 20 ml MDV 20 ml C (68-77 F) N Y mg/ml 3 ml SDV 2 ml C (68-77 F) Y Y

8 * Product Requires Refrigeration PF - Preservative Free Y - Yes ABC = AmerisourceBergen * Triostat liothyronine sodium injection (T 3 ) mcg/ml 2 ml SUV 1 ml C (36-46 F) Y Y mcg/ml 2 ml SUV 1 ml C (36-46 F) Y Y * Vasostrict Vasopressin Injection, USP units/ml 3 ml MDV 1 ml C (36-46 F) N Y Do not freeze Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions (20 C to 25 C [68 F to 77 F], USP Controlled ), anytime within the labeled shelf life. Zoledronic Acid Injection mg/ml 100 ml SDB 100 ml 1 25º C (77º F); excursions Y Y permitted to 15º to 30ºC (59º to 86ºF ) mg/ml 5 ml SDV 5 ml 1 25º C (77º F); excursions Y Y permitted to 15º to 30ºC (59º to 86ºF ) 8

9 RETURN GOODS POLICY This Return Goods Policy (the Policy ) of Par Sterile Products, Inc. applies to Par s sterile injectable pharmaceutical products (sometimes collectively referred to herein as Product ) distributed by Par Sterile Products Inc., or JHP Pharmaceuticals, Inc. (collectively referred to herein as PSP ). This policy does not apply to brand or generic Products distributed by Par Pharmaceutical Inc. or Anchen Pharmaceuticals, Inc. PSP will only accept the return of Product for consideration of credit or refund, if applicable, under the following conditions and limitations: This Policy is in effect as of November 1, 2014 and supersedes all previous policies. Return Authorization Designee Inmar Inc. ( MedTurn ) is the approved return goods agent for PSP. Customers returning eligible return goods to Inmar do not incur any processing fees or service charges. Inmar will accept PSP return goods shipments from other third party return goods processors provided such processors comply with all requirements of this Policy. PSP reserves the right to deny credit for returns sent to reverse distribution vendors other than Inmar. Return Instructions All Returns must be sent directly to Inmar. Use one of the following options to initiate each return. 1. Access the Inmar website at (customers are required to upload a debit memo copy in PDF format). 2. debit memo to Be sure to include NDC#, lot# and expiration dates assigned to each item. 3. Fax debit memo to Inmar at Questions about the returns process may be directed to Inmar s customer service at (800) Monday through Friday between the hours of 7:00am and 5:00pm central time. Request for return or return Product does not constitute PSP s acceptance for credit. The package size, lot number and lot expiration date will be obtained and verified after receipt of Product at Inmar. Product should be shipped pre-paid to: Inmar South Dock 4332 Empire Road Fort Worth, TX Returns of Product must include a packing list containing the following information: Name and address of facility returning Product Phone number DEA number List of Product including quantity being returned, lot number and expiration date of each An Inmar box label must accompany all returns for proper credit A detailed debit memo indicating total number of units being returned must be included with all returns for reimbursement. NDC and lot numbers on customer debit memo must match that of the PSP NDC and lot number of the full unit of measure marketed by PSP (must use parent NDC and lot, not child or sub NDC or lot, if applicable). All eligible Product shipped to Inmar must be shipped in a safe, secure and reliable manner, and in compliance with all applicable federal, state and local laws. PSP is not responsible for shipments lost and/or damaged in transit. It is suggested that the customer returning Product insure all shipments. Dantrium Intravenous Lyophilized Powder for Injection 20mg 70mL SDV 6 s ( Dantrium IV ) is not returnable for credit but is returnable for destruction. Terms of Return Policy PSP will only consider for return Product that is purchased directly from PSP or through an agent authorized by PSP to sell PSP Product. Controlled Substances Controlled substances must be returned to Inmar in accordance with Federal and State regulations governing the transfer of these substances. Submission of DEA Form 41s, in lieu of returning Product to Inmar, will not qualify for credit. Customer shall contact Inmar at (800) as described above and Inmar shall provide designated label and DEA 222 form. Prior to the return of any Schedule II narcotic, a DEA Form 222 must be issued by Inmar and the completed form must accompany the return goods shipment. Schedule II Product must be returned separate and apart from Schedule III, IV, and V Product and non-controlled Product. Schedule II return goods shipments must be shipped in an unmarked container via UPS, DHL or FedEx. Valuation of Returns For direct customers, a credit will be issued based upon the lower of the current Wholesaler Acquisition Cost (WAC) at the time the returned merchandise is received by Inmar OR the lowest invoice price paid. For returns of Product purchased indirectly and returned through a wholesaler or distributor, a credit will be issued at the lower of the current or most recently available net contract price at the time the returned merchandise is received by Inmar. If none exists, or cannot reasonably be determined, then credit will be based on 50% of the current WAC price. Returnable Items For the purpose of this Policy, returns will be accepted for credit only if such returned Product is in accordance with the requirements set forth below: Unopened, sealed containers (i.e. unopened vials, bottles, etc.) returned in the original labeled package; Valid Lot number and expiration date are legible; Product returned no more than six (6) months prior to the expiration date; Product returned no more than six (6) months after the expiration date; Recalled Product returned separately from short dated or expired Product and returned through PSP s approved Recall Processing Service. PSP will only accept returns from customers who have purchased Product directly from PSP. Returns from indirect customers will be accepted only if the debit memo provides for remittance through a direct customer of PSP. Returns are to be made to the wholesaler/distributor from which the Product was purchased. Check reimbursement will not be offered in lieu of credit. Non-Returnable Items Non-Returnable Items include the following: Partially or fully opened containers (no partial credits will be issued except as required by state or local laws); Product more than six (6) months prior to expiration date; Product more than six (6) months after expiration date; Product requiring refrigeration or product that is required to be stored and maintained under temperature controlled conditions. Product where either the lot number, the NDC number, and/or expiration date is missing, covered, removed, or unreadable; Professional samples, professional packages or free goods; 9

10 Open, unsealed packages or empty containers; Product damaged by water, fire, smoke, or due to improper storage conditions or other insurable events Product involved in salvage, bankruptcy or insolvency proceedings; Product sold, purchased or distributed in violation of federal, state or local law; Packages from which labels have been defaced, covered, removed, or unreadable; or in leaking containers; Private label, repackaged Product, or any Product manufactured to customer specs; Product that is otherwise adulterated, misbranded, or counterfeit, as determined by PSP, in its sole discretion; Overstock items; Product that has been donated; Product sold expressly on a non-returnable basis; Non approved returns; Product not distributed by PSP; Product destroyed by any wholesaler or third party processor for customer or wholesaler not authorized by PSP; Product destroyed in the field, regardless of whether proof of destruction is supplied; Product returned by anyone other than the original purchaser. PSP reserves the right to request proof of purchase prior to authorizing any returns; Product returned to PSP s distribution center without prior approval; Returns to PSP s distribution center made after thirty (30) days from date of approval; Product not purchased directly from PSP or obtained other than through a source of normal distribution channels and/or purchased from a source other than an approved distributor of PSP. Product that has been purchased from sources outside of the United States, Puerto Rico or US territories; Product shall be ineligible for return when the intent of the customer is to temporarily reduce inventory. Credit may be reduced or refused when inadequate inventory controls cause excessive Product returns. Dantrium Intravenous Lyophilized Powder for Injection 20mg 70mL SDV 6 s ( Dantrium IV ) is not returnable for credit but is returnable for destruction. Ineligible Product should not be sent back to PSP. Product not eligible for return and sent to Inmar will not be returned to sender and will not be eligible for credit. PSP reserves the right to destroy any Product that is not eligible for credit without payment or liability. PSP reserves the right to deduct costs incurred for the processing/ destruction of ineligible returned Product from the total credit of the return. Delivery and Shipping Exceptions For Product returns due to shipping error or Product damaged in shipment, contact PSP s Return Goods Administration at , option #5, and then press #3 or visit our website, for more information. When PSP Product is found to be missing from a delivered shipment an immediate notification must be initiated to PSP by calling , option #5, and then press #3. The loss of DEA regulated Product (Control Drug Substances) require a notification to Federal Authorities within 24 hours of a finding which must be initiated by PSP should a loss be reported by our customer. Product shipped directly by PSP that is damaged in transit, subject to F.O.B terms; Product shipped in error by PSP, and/or concealed damage at time of shipment, must be reported to PSP s Return Goods 10 Administration within five (5) business days from date of receipt. Controlled Substance Product shipped directly by PSP that is damaged in transit, subject to F.O.B. terms; Product shipped in error by PSP, and/or concealed damage at time of shipment must be reported to PSP s Return Goods Administration within 24 hours of receipt. Subject to approval by PSP, an even exchange or credit will be allowed for loss or damage evident at delivery time if noted on the carriers delivery receipt and reported to PSP within five (5) days. Concealed loss or damage must be inspected by the carrier within fifteen (15) days after delivery and Carrier s inspection report must be forwarded to PSP. Product damaged at customer s warehouse or store level will not be credited or replaced. Additional Terms PSP will issue credit for returns in compliance with all federal and state requirements Unauthorized deductions for returned merchandise are not permitted without prior approval. Debit memo amounts are pro-forma estimates only and are not considered as valid and therefore should not be deducted from payments to PSP until such time as payment of amount due, if any, is determined by PSP and credit is issued. Returned quantities will be audited by PSP s authorized agent and final credit will be based on PSP s authorized agent s count. PSP reserves the sole right to determine whether items qualify for return or credit. PSP s determination of the physical count of the returned Product will be final. With the exception of recalled Product, or where due to PSP s error, PSP will not pay for, nor reimburse wholesalers or any customer for, any return goods transportation costs, handling fees, or processing fees incurred on the part of the wholesaler/ distributor, distributor s return goods processor or customer. Direct customers are not permitted to deduct from any payment any such return transportation costs, handling fees or processing fees. PSP will not reimburse customers for destruction charges for Product destroyed by any party other than PSP s authorized agent. Any and all credits provided under this Policy are only valid if redeemed within one year of issuance. Credit will be issued to direct purchasing customers within sixty (60) days after receipt of an approved return. Customers may not take deductions for returns prior to the issuance of a credit memo. All claims relating to Product returns must be made in writing to PSP within twelve (12) months of date of return. Any claim made outside of this notice period will not be reviewed or considered. When indirect returns are processed by a third Party, proof of destruction must be provided in order for credit to be issued. PSP reserves the right to verify all Product returns to make certain that they conform to this Policy. PSP reserves the right to modify and make changes to this Policy without notice. Pre-Authorized in-date returns due to overstock are subject to a 20% handling and restocking fee. Prior written approval by PSP is required and chain of custody documented and approved by PSP.

11 Drug Safety / Medical Information To report adverse events or product complaints, or for medical information inquiries, please call: Phone: Option 3 EFax: For customer service inquiries, please call: , option 5, option PSPM