FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:
Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.
DRUG/ALCOHOL TESTING Section 33.1 Drug testing may be conducted on employees during their duty hours upon reasonable suspicion or randomly by computer selection. Alcohol testing will be conducted only upon reasonable suspicion. Reasonable suspicion that an employee used or is using a controlled substance or alcohol in an unlawful or abusive manner may be based upon, but not limited to:
A. Observable phenomena, such as direct observation of drug or alcohol use or possession and/or the physical symptoms of being under the influence of a drug or alcohol;
B. A pattern or abnormal conduct or erratic behavior, including abnormal leave patterns;
C. Arrest or conviction for a drug or alcohol-related offense, or the identification of an employee as the focus of a criminal investigation into illegal drug or alcohol possession, use, or trafficking;
D. Information provided either by reliable and credible sources or independently corroborated;
E. Evidence that an employee has tampered with a previous drug test;
F. Facts or circumstances developed in the course of an authorized investigation of an accident or unsafe working practices.
Section 33.2 Drug/alcohol testing shall be conducted solely for administrative purposes and the results obtained shall not be used in criminal proceedings. Under no circumstances may the results of drug/alcohol screening or testing be released to a third party for use in a criminal prosecution against the affected employee. The following procedure shall not preclude the Employer from other administrative action but such actions shall not be based solely upon the initial reagent testing results alone.
Section 33.3 All drug screening tests shall be conducted by laboratories meeting the standards of the Substance Abuse and Mental Health Service Administration. No test shall be considered positive until it has been confirmed by a Gas Chromatography/Mass Spectrometry. The procedures utilized by the Employer and testing laboratory shall include an evidentiary chain of custody control and split sample testing. All procedures shall be outlined in writing and this outline shall be followed in all situations arising under this article.
Section 33.4 Alcohol testing shall be done in accordance with the law of the State of Ohio to detect drivers operating a motor vehicle under the influence. A positive result shall entitle the Employer to proceed with sanctions as set forth in this Article.
Section 33.5 The results of the testing shall be delivered to a specified employee of the Employer with command responsibility and the employee tested. An employee whose confirmatory test result is positive shall have the right to request a certified copy of the testing results in which the vendor shall affirm that the test results were obtained using the approved protocol methods. The employee shall provide a signed release for disclosure of the testing results to the Employer. A representative for the bargaining unit shall have a right of access to the results upon request to the Employer, with the employee’s written consent. Refusal to submit to the testing provided for under this Agreement may be grounds for discipline.
A. If a drug screening test is positive, a confirmatory test shall be conducted utilizing the fluid from the primary sample.
B. In the event that any confirmation drug test results are positive, the employee is entitled to have the split sample tested by another DHHS-certified lab in the manner prescribed above at the employee’s expense. The employee must request the split sample test within seventy-two (72) hours of being notified of a positive result. The results of this test, whether positive or negative, shall be determinative.
Section 33.7 A list of three (3) testing laboratories shall be maintained by the Employer. These laboratories shall conduct any testing directed by the Employer. The Employer shall obtain the approval of the bargaining unit representative as to any laboratories put on this list, which approval shall not be unreasonably withheld.
Section 33.8 If after the testing required above has produced a positive result the Employer may require the employee to participate in any rehabilitation or detoxification program that is covered by the employee’s health insurance. Discipline allowed by the positive findings provided for above shall be deferred pending rehabilitation of the employee within a reasonable period. An employee who participates in a rehabilitation or detoxification program shall be allowed to use sick time and vacation leave for the period of the rehabilitation or detoxification program. If no such leave credits are available, the employee shall be placed on medical leave of absence without pay for the period of the rehabilitation or detoxification program. Upon completion of such program and upon receiving results from a retest demonstrating that the employee is no longer abusing a controlled substance/alcohol, the employee shall be returned to his/her former position. Such employee may be subject to periodic retesting upon his/her return to his/her position for a period of one (1) year from the date of his/her return to work. Any employee in a rehabilitation or detoxification program in accordance with this Article will not lose any seniority or benefits, should it be necessary for the employee to be placed on medical leave of absence without pay, for a period not to exceed ninety (90) days.
Section 33.9 If the employee refuses to undergo rehabilitation or detoxification, or if he/she tests positive during a retesting within one (1) year after his/her return to work from such a program, the employee shall be subject to disciplinary action, including removal from his/her position and termination of his/her employment.
Section 33.10 Costs of all drug screening tests and confirmatory tests shall be borne by the Employer except that any test initiated at the request of the employee shall be at the employee’s expense.
Section 33.11 The Employer may conduct four (4) tests of an employee during the one (1) year period after the employee has completed a rehabilitation or detoxification program as provided above.
Section 33.12 The provisions of this Article shall not require the Employer to offer a rehabilitation/detoxification program to any employee more than once.
Prescription Drugs The agreement may impose a variety of limits affecting the scope or duration of benefits that are not expressed numerically. An example of these types of treatments limit is preauthorization. Preauthorization is applied to behavioral health services in the same way as medical benefits. The only exception is except where clinically appropriate standards of care may permit a difference. Mental disorders are covered under Section A. Mental Health Services. Substance abuse disorders are covered under
Recall List The Board shall maintain a recall list. Copies of the list will be sent to each person on the list and the Association at least once during the fall and once during the spring each year.
Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.
Preventive Drugs When purchased at any pharmacy: Must be prescribed by a physician. See Prescription Drug section for details. $0 Not Covered Nicotine Replacement Therapy (NRT) and Smoking Cessation Prescription Drugs When purchased at any pharmacy: Must be prescribed by a physician. See Prescription Drug section for details. Tier 1 Preventive: $0 Tier 1 Non-preventive: $10 - After deductible Not Covered Tier 2 Preventive: $0 Tier 2 Non-preventive: $45 - After deductible Not Covered Tier 3: $70 - After deductible Not Covered Tier 4: $90 - After deductible Not Covered Tier 5: NRT and Smoking Cessation drugs are only placed in Tier 1, Tier 2, Tier 3, or Tier 4. See above. Not Covered When purchased at a Mail Order Pharmacy: Not Covered Not Covered
Prescription Drugs and Diabetic Equipment or Supplies Biological products for allergen immunotherapy and vaccinations. • Blood fractions. • Compound prescription drugs that are not made up of at least one legend drug. • Bulk powders and chemicals used in compound prescriptions that are not FDA approved, are not covered unless listed on our formulary. • Prescription drugs prescribed or dispensed outside of our dispensing guidelines. • Prescription drugs ordered or prescribed based solely on online questionnaires, telephonic interviews, surveys, emails, or any other marketing solicitation methods, whether alone or in combination. • Prescription drugs that have not proven effective according to the FDA. • Prescription drugs used for cosmetic purposes. • Prescription drugs purchased from a non-designated pharmacy, if a pharmacy has been designated for you through the Pharmacy Home Assignment program. • Experimental prescription drugs including those placed on notice of opportunity hearing status by the Federal Drug Efficacy Study Implementation (DESI). • Prescription drugs provided to you that are not dispensed by a network pharmacy or covered under your medical plan. • Prescription drugs and diabetic equipment and supplies purchased at a non-network pharmacy unless indicated as covered in the Summary of Pharmacy Benefits. • Prescription drug related medical supplies except for diabetic, regardless of the reason prescribed, the intended use, or medical necessity. Examples include, but are not limited to, alcohol pads, bandages, wraps or pill holders. • Off-label use of prescription drugs except as described in Experimental or Investigational Services in Section 3; • Prescribed weight-loss drugs. • Replacement of prescription drugs resulting from a lost, stolen, broken or destroyed prescription order or refill. • Therapeutic devices and appliances, including hypodermic needles and syringes except when used to administer insulin. • Prescription drugs, therapeutic equivalents, or any other pharmaceuticals used to treat sexual dysfunctions. • Vitamins, unless specifically listed as a covered healthcare service. • A prescription drug refill greater than the refill number authorized by your physician, more than a year from the date of the original prescription, or limited by law. • Long acting opioids and other controlled substances, nicotine replacement therapy, and specialty prescription drugs when purchased from a mail order pharmacy. • Prescription drugs and specialty prescription drugs when the required prescription drug preauthorization is not obtained. • Certain prescription drugs that have an over-the-counter (OTC) equivalent. • Prescriptions filled through an internet pharmacy that is not a verified internet pharmacy practice site certified by the National Association of Boards of Pharmacy. • Illegal drugs, including medical marijuana, which are dispensed in violation of state and/or federal law. • Services of a nurse's aide. • Services of a private duty nurse: o when the primary duties are limited to bathing, feeding, exercising, homemaking, giving oral medications or acting as companion or sitter; o after the caregiver or patient have demonstrated the ability to carry out the plan of care; o provided outside the home. Examples include at school, or in a nursing or assisted living facility; o that are duplication or overlap of services. Examples include when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit; o that are for observation only; and o provided as part-time/intermittent and not continuous care. • Maintenance care when the condition has stabilized including routine ostomy care or tube feeding administration or if the anticipated need is indefinite. • Twenty-four (24) hour private duty nursing care for a person without an available caregiver in the home. • Respite care (e.g., care during a caregiver vacation) or private duty nursing so that the caregiver may attend work or school. • Abdominoplasty. • Brow ptosis surgery. • Cervicoplasty. • Chemical exfoliations, peels, abrasions, dermabrasions, or planing for acne, scarring, wrinkling, sun damage or other benign conditions. • Correction of variations in normal anatomy including augmentation mammoplasty, mastopexy, and correction of congenital breast asymmetry. • Dermabrasion. • Ear piercing or repair of a torn earlobe. • Excision of excess skin or subcutaneous tissue except for panniculectomy. • Genioplasty. • Hair transplants. • Hair removal including electrolysis epilation, unless in relation to gender reassignment services or skin grafting. • Inverted nipple surgery. • Laser treatment for acne and acne scars. • Osteoplasty - facial bone reduction. • Otoplasty. • Procedures to correct visual acuity including but not limited to cornea surgery or lens implants. • Removal of asymptomatic benign skin lesions. • Repeated cauterizations or electrofulguration methods used to remove growths on the skin. • Rhinoplasty.
