Articles intended for use as a component of any such articles; except that the term shall not include soap. Any requirement made by or under authority of this article, that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement or other information also appears on the outside container or wrapper, if there be any, of the retail package of such drug, device or cosmetic or is easily legible through the outside container or wrapper.
Upon any drug, device or cosmetic or any of its containers or wrappers, or b.
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Accompanying such drug, device or cosmetic. If a drug, device or cosmetic is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading then in determining whether the labeling or advertisement is misleading there shall be taken into account among other things not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the drug, device, or cosmetic to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
No drug, device or cosmetic which is subject to, and complies with regulations promulgated under the provisions of the federal food, drug, and cosmetic act, relating to adulteration and misbranding shall be deemed to be adulterated or misbranded in violation of the provisions of this article because of its failure to comply with the board's regulations, or the rules of the state board of pharmacy, insofar as the regulations are in conflict with regulations relating to adulteration and misbranding under the federal food, drug and cosmetic act.
The representation of a drug, device or cosmetic in its labeling, as an antiseptic, shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body. Any drug not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested by the drug's labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to September first, nineteen hundred thirty-nine it was subject to the former federal food and drug act of June thirtieth, nineteen hundred six, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; Any drug, the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become recognized, but which has not otherwise than in such investigations been used to a material extent or for a material time under such conditions.
For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or To affect the structure or any function of the body of man or animals. The term "Federal Food, Drug and Cosmetic Act" means the Federal Food, Drug, and Cosmetic Act of the United States of America, approved June twenty-fifth, nineteen hundred thirty-eight, officially cited as public document number seven hundred seventeen-seventy-fifth congress chapter six hundred seventy-five--third session , and all its amendments now or hereafter enacted.
If the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner of health may issue a non-patient specific regimen applicable statewide. If the commissioner of health determines that there is an outbreak of influenza, or that there is the imminent threat of an outbreak of influenza, then the commissioner of health may issue a non-patient specific regimen applicable statewide.
Section k 4 as set forth in the latest edition or supplement of the United States Food and Drug Administration Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes referred to as the "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent as set forth in the latest edition or supplement of the United States Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book.
Practice of pharmacy and use of title "pharmacist". State board of pharmacy. The board shall have power: To regulate the practice of pharmacy and the employment of interns and employees in pharmacies, To regulate and control the sale, distribution, character and standard of drugs, poisons, cosmetics, devices and new drugs, To employ inspectors and chemists, To prevent the sale or distribution of such drugs, poisons, cosmetics, devices and new drugs as do not conform to the provisions of this article or of the public health law, To investigate alleged violations of the provisions of this article, through its own investigative personnel or those of other agencies, to conduct hearings, to levy money penalties, and to bring alleged violations to the notice of the attorney general, and To issue limited permits or registrations.
Requirements for a professional license. To qualify for a pharmacist's license, an applicant shall fulfill the following requirements: On or before April first, nineteen hundred seventy-two, any person who holds a valid license as "druggist" in this state shall make application and on the payment of fees specified in this title be licensed by the department as a pharmacist. Such person shall have all of the rights, privileges, duties and responsibilities of a pharmacist. The department may issue a limited permit for employment as a "pharmacy intern" to: A student enrolled in the last two years of a registered program in pharmacy, or A graduate of a program in pharmacy which meets standards established by the commissioner's regulations who is engaged in meeting the experience requirements or whose application for initial licensure is pending with the department.
A pharmacy intern may, as determined by the commissioner's regulations, practice as a pharmacist under the immediate personal supervision of a licensed pharmacist. A limited permit issued to a pharmacy intern shall have an expiration date of five years from the date of issue. Limited permits may be renewed once for a period not to exceed two years. The fee for each limited permit issued to a pharmacy intern shall be seventy dollars.
This article shall not be construed to affect or prevent: Notwithstanding the provisions of paragraph b of subdivision one of this section, no prescriber who is not the owner of a pharmacy, or registered store, or who is not in the employ of such owner, may dispense more than a seventy-two hour supply of drugs, except for: The commissioner, in consultation with the commissioner of health, may promulgate regulations to implement this subdivision and may, by regulation, establish additional renewable exemptions for a period not to exceed one year from the provisions of paragraph a of this subdivision.
A pharmacist may dispense drugs and devices to a registered professional nurse, and a registered professional nurse may possess and administer, drugs and devices, pursuant to a non-patient specific regimen prescribed or ordered by a licensed physician or certified nurse practitioner, pursuant to regulations promulgated by the commissioner and the public health law. Registering and operating establishments. No person, firm, corporation or association shall possess drugs, prescriptions or poisons for the purpose of compounding, dispensing, retailing, wholesaling, or manufacturing, or shall offer drugs, prescriptions or poisons for sale at retail or wholesale unless registered by the department as a pharmacy, wholesaler, manufacturer or outsourcing facility.
A pharmacy shall be registered as follows: The application shall be made on a form prescribed by the department. The application shall be accompanied by a fee of three hundred forty-five dollars. To secure and retain a registration, a pharmacy must be equipped with facilities, apparatus, utensils and stocks of drugs and medicines sufficient to permit the prompt and efficient compounding and dispensing of prescriptions, as prescribed by regulation.
All pharmacy registrations shall be renewed on dates set by the department. The triennial registration fee shall be two hundred sixty dollars or a pro rated portion thereof as determined by the department At the time of renewal, the owner of every pharmacy shall report under oath to the department any facts required by the board of pharmacy. The registration shall be conspicuously displayed at all times in the pharmacy.
The names of the owner or owners of a pharmacy shall be conspicuously displayed upon the exterior of such establishment. The names so displayed shall be presumptive evidence of ownership of such pharmacy by such person or persons. In the event that the owner of a licensed pharmacy is not a licensed pharmacist, the pharmacy registration issued shall also bear the name of the licensed pharmacist having personal supervision of the pharmacy.
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In the event that such licensed pharmacist shall no longer have personal supervision of the pharmacy, the owner shall notify the department of such fact and of the name of the licensed pharmacist replacing the pharmacist named on the license and shall apply for an amended registration showing the change. The amended registration must be attached to the original registration and displayed in the same manner.
Both the owner and the supervising pharmacist shall be responsible for carrying out the provisions of this article. In the event that the location of a pharmacy shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location. The fee for inspection and endorsement shall be fifty dollars, unless it appears to the satisfaction of the department that the change in location is of temporary nature due to fire, flood or other disaster. Conduct of a pharmacy.
Every owner of a pharmacy is responsible for the strength, quality, purity and the labeling thereof of all drugs, toxic substances, devices and cosmetics, dispensed or sold, subject to the guaranty provisions of this article and the public health law. Every owner of a pharmacy or every pharmacist in charge of a pharmacy shall be responsible for the proper conduct of this pharmacy.
Every pharmacy shall be under the immediate supervision and management of a licensed pharmacist at all hours when open. No pharmacist shall have personal supervision of more than one pharmacy at the same time. A pharmacy as a department. When a pharmacy is operated as a department of a larger commercial establishment, the area comprising the pharmacy shall be physically separated from the rest of the establishment, so that access to the pharmacy and drugs is not available when a pharmacist is not on duty.
Identification of the area within the pharmacy by use of the words "drugs", "medicines", "drug store", or "pharmacy" or similar terms shall be restricted to the area licensed by the department as a pharmacy. When, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the registering of a pharmacy within a hospital, nursing home or extended care facility which does not meet all of the requirements for registration as a pharmacy, the department may waive any requirements pertaining to full-time operation by a licensed pharmacist, minimum equipment, minimum space and waiting area, provided that when the waiver of any of the above requirements is granted by the board, the pharmaceutical services to be rendered by the pharmacy shall be limited to furnishing drugs to patients registered for treatment by the hospital, and to in-patients for treatment by the nursing home or extended care facility.
When in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the registering of a pharmacy within a facility distributing dialysis solutions for patients suffering from end stage renal disease and where the pharmaceutical services to be rendered by the pharmacy shall be limited to furnishing dialysis solutions to patients for whom such has been prescribed by a duly authorized prescriber, the department may waive certain requirements, including, but not limited to, full-time operation by a licensed pharmacist, minimum equipment, and minimum space and waiting area.
Such solutions shall only be dispensed by employees who have completed an approved training program and who have demonstrated proficiency to perform the task or tasks of assemblying, labeling or delivering a patient order and who work under the general supervision of a licensed pharmacist who shall be responsible for the distribution, record keeping, labeling and delivery of all dialysis solutions dispensed by the distributor as required by the department. The department shall promulgate such rules or regulations consistent with this paragraph as are necessary to ensure the safe distribution of such dialysis solution, including establishment registration and proper record keeping, storage, and labeling.
The initial registration fee and renewal fee for a limited pharmacy shall be three hundred forty-five dollars for each triennial registration period. An applicant for registration as a pharmacy shall be of good moral character, as determined by the department. In the case of a corporate applicant, the requirement shall extend to all officers and directors and to stockholders having a ten percent or greater interest in the corporation. A wholesaler or manufacturer shall be registered as follows: The application shall be accompanied by a fee of eight hundred twenty-five dollars.
All wholesalers' and manufacturers' registrations shall be renewed on dates set by the department. The triennial registration fee shall be five hundred twenty dollars or a pro rated portion thereof as determined by the department Display of registration. The registration shall be displayed conspicuously at all times in the place of business. In the event that the location of such place of business shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location.
The fee for inspection and endorsement shall be one hundred seventy dollars, unless it appears to the satisfaction of the department that the change in location is of a temporary nature due to fire, flood or other disaster. An outsourcing facility shall be registered as follows: An application for initial registration or renewal of registration shall be made on a form prescribed by the department. An application for initial registration shall be accompanied by a fee of eight hundred twenty-five dollars.
All outsourcing facilities' registrations shall be renewed on a date set by the department. The triennial registration fee shall be five hundred twenty dollars or a pro rated portion thereof as determined by the department. The registration shall be displayed conspicuously in the place of business. The fee for inspection and endorsement shall be one hundred seventy-five dollars, unless it appears to the satisfaction of the department that the change in location is of a temporary nature due to fire, flood or other disaster.
Upon initially registering as an outsourcing facility and every six months thereafter, each outsourcing facility shall submit to the executive secretary of the state board of pharmacy a report: Conduct of outsourcing facility. Every owner of an outsourcing facility is responsible for the strength, quality, purity and labeling thereof of all compounded drugs, subject to the guaranty provisions of this article and the public health law.
Every outsourcing facility shall be under the immediate supervision and management of a pharmacist licensed to practice in New York state. An applicant for registration of an outsourcing facility shall be of good moral character, as determined by the department. In the case of a corporate applicant, the requirement shall extend to all officers and directors and stakeholders having a ten percent or greater interest in the corporation.
The state board of pharmacy and the department of education, and their employees designated by the commissioner, shall have the right to enter any pharmacy, wholesaler, manufacturer, outsourcing facility or vehicle and to inspect, at reasonable times, such factory, warehouse, establishment or vehicle and all records required by this article, pertinent equipment, finished and unfinished materials, containers, and labels. A pharmacy, wholesaler, manufacturer or outsourcing facility registered under this section shall be under the supervision of the board of regents and shall be subject to disciplinary proceedings and penalties in accordance with article one hundred thirty of this chapter in the same manner and to the same extent as individuals and professional service corporations with respect to their licenses and registrations, provided that failure to comply with the requirements of this section shall constitute professional misconduct.
Sale of drugs at auction. No controlled substance or substances and no poisonous or deleterious drugs or drugs in bulk or in opened containers shall be sold at auction unless the place where such drugs are sold at auction shall have been registered by the board, and unless such sale shall be under the personal supervision of a licensed pharmacist. Drugs in open containers shall not be sold at auction unless the seller shall have in his possession a certificate of the board showing that such drugs have been inspected and meet the requirements of this article.
In the event that the drug so sold is one as to which this article or any federal statute or any regulation adopted pursuant to this article or an applicable federal statute require that the expiration date be stated on each package, such drug may not be sold at auction after such expiration date or when such expiration date will occur within a period of thirty days or less from the date of sale. Registration of nonresident establishments. Such establishments shall include, but not be limited to, pharmacies that transact business through the use of the internet.
The provisions of this subdivision shall apply solely to nonresident establishments and shall not affect any other provision of this article. As a condition of registration, a nonresident establishment shall comply with the following requirements: Nonresident pharmacies registered pursuant to this section shall: Except in emergencies that constitute an immediate threat to public health, the department shall not prosecute a complaint or otherwise take formal action against a nonresident establishment based upon delivery of a drug into this state or a violation of law, rule, or regulation of this state if the agency having jurisdiction in the state where the nonresident establishment is based commences action on the violation complained of within one hundred twenty days from the date that the violation was reported; provided however, that the department may prosecute a complaint or take formal action against a nonresident establishment if it determines that the agency having jurisdiction in the state where the nonresident establishment is based has unreasonably delayed or otherwise failed to take prompt and appropriate action on a reported violation.
A nonresident establishment that fails to comply with the requirements of this section shall be subject to revocation or suspension of its registration and other applicable penalties in accordance with the provisions of article one hundred thirty of this chapter. The department shall promulgate rules and regulations to implement the provisions of this section. No drug for which a prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health shall be distributed or dispensed to any person except upon a prescription written by a person legally authorized to issue such prescription.
Such drug shall be compounded or dispensed by a licensed pharmacist, and no such drug shall be dispensed without affixing to the immediate container in which the drug is sold or dispensed a label bearing the name and address of the owner of the establishment in which it was dispensed, the date compounded, the number of the prescription under which it is recorded in the pharmacist's prescription files, the name of the prescriber, the name and address of the patient, and the directions for the use of the drug by the patient as given upon the prescription.
All labels shall conform to such rules and regulations as promulgated by the commissioner pursuant to section sixty-eight hundred twenty-nine of this article. The prescribing and dispensing of a drug which is a controlled substance shall be subject to additional requirements provided in article thirty-three of the public health law.
The words "drug" and "prescription required drug" within the meaning of this article shall not be construed to include soft or hard contact lenses, eyeglasses, or any other device for the aid or correction of vision. Nothing in this subdivision shall prevent a pharmacy from furnishing a drug to another pharmacy which does not have such drug in stock for the purpose of filling a prescription.
A prescription may not be refilled unless it bears a contrary instruction and indicates on its face the number of times it may be refilled. A prescription may not be refilled more times than allowed on the prescription. The date of each refilling must be indicated on the original prescription. Prescriptions for controlled substances shall be refilled only pursuant to article thirty-three of the public health law. A pharmacy registered with the department pursuant to section sixty-eight hundred eight or sixty-eight hundred eight-b of this article may not deliver a new or refilled prescription off premises without the consent of the patient or an individual authorized to consent on the patient's behalf.
For the purposes of this section, consent may be obtained in the same manner and process by which consent is deemed acceptable under the federal Medicare Part D program Pharmacy providers who deliver medication without patient or authorized individual consent will be required to accept the return of the medication from the patient, provide that patient credit for any charges they may have paid, and will be required to destroy those medications sent without consent on delivery in accordance with applicable state and federal law.
Nothing in this section shall be deemed to interfere with the requirements for refill reminder or medication adherence programs. Nothing in this section is intended to apply to long-term care pharmacy dispensing and delivery. A copy of a prescription for a controlled substance shall not be furnished to the patient but may be furnished to any licensed practitioner authorized to write such prescription. Copies of other prescriptions shall be furnished to the patient at his request, but such copies are issued for the informational purposes of the prescribers only, and shall be so worded.
Oral prescriptions for controlled substances shall be filled pursuant to article thirty-three of the public health law. A pharmacist may fill an oral prescription for a drug, other than a controlled substance, made by a practitioner legally authorized to prescribe drugs. An oral authorization for the refill of a prescription, other than a prescription for a controlled substance, may be made by a practitioner legally authorized to prescribe drugs.
The pharmacist receiving such oral authorization for the refill of a prescription shall write on the reverse side of the original prescription the date, time, and name of the practitioner authorizing the refill of the prescription. An oral prescription or an oral authorization for the refill of a prescription for the drug, other than a controlled substance, may be communicated by an employee of the prescribing practitioner; provided, however, the pharmacist shall: Oral prescriptions for patients in general hospitals, nursing homes, residential health care facilities as defined in section twenty-eight hundred one of the public health law, hospitals as defined in subdivision ten of section 1.
Such agent shall be a health care practitioner currently licensed and registered under this title. Records of all prescriptions filled or refilled shall be maintained for a period of at least five years and upon request made available for inspection and copying by a representative of the department.
Such records shall indicate date of filling or refilling, doctor's name, patient's name and address and the name or initials of the pharmacist who prepared, compounded, or dispensed the prescription. Records of prescriptions for controlled substances shall be maintained pursuant to requirements of article thirty-three of the public health law.
Every prescription written in this state by a person authorized to issue such prescription shall be on prescription forms containing one line for the prescriber's signature.
The prescriber's signature shall validate the prescription. Every electronic prescription shall provide for the prescriber's electronic signature, which shall validate the electronic prescription. Imprinted conspicuously on every prescription written in this state in eight point upper case type immediately below the signature line shall be the words: Unless the prescriber writes d a w in such box in the prescriber's own handwriting or, in the case of electronic prescriptions, inserts an electronic direction to dispense the drug as written, the prescriber's signature or electronic signature shall designate approval of substitution by a pharmacist of a drug product pursuant to paragraph o of subdivision one of section two hundred six of the public health law.
No other letters or marks in such box shall prohibit substitution. No prescription forms used or intended to be used by a person authorized to issue a prescription shall have 'd a w' preprinted in such box.
Article 137, Pharmacy
Such box shall be placed directly under the signature line and shall be three-quarters inch in length and one-half inch in height, or in comparable form for an electronic prescription as may be specified by regulation of the commissioner. Immediately below such box shall be imprinted in six point type the words "Dispense As Written". Notwithstanding any other provision of law, no state official, agency, board or other entity shall promulgate any regulation or guideline modifying those elements of the prescription form's contents specified in this subdivision.
To the extent otherwise permitted by law, a prescriber may modify only those elements of the prescription form's contents not specified in this subdivision. Notwithstanding any other provision of this section or any other law, when a generic drug is not available and the brand name drug originally prescribed is available and the pharmacist agrees to dispense the brand name product for a price that will not exceed the price that would have been charged for the generic substitute had it been available, substitution of a generic drug product will not be required.
If the generic drug product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the brand name product at his regular price.
In such instances the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions. If the interchangeable biological product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the prescribed biological product at his regular price.
No drug shall be dispensed by a pharmacist when such prescription form includes any other drug. With respect to drugs other than controlled substances, the provisions of this subdivision shall not apply to pharmacists employed by or providing services under contract to general hospitals, nursing homes, residential health care facilities as defined in section twenty-eight hundred one of the public health law, hospitals as defined in subdivision ten of section 1. With respect to such pharmacists, each prescription shall be transcribed on a patient specific prescription form.
Every prescription whether or not for a controlled substance written in this state by a person authorized to issue such prescription and containing the prescriber's signature shall, in addition to such signature, be imprinted or stamped legibly and conspicuously with the printed name of the prescriber who has signed the prescription. The imprinted or stamped name of the signing prescriber shall appear in an appropriate location on the prescription form and shall not be entered in or upon any space or line reserved for the prescriber's signature.
The imprinted or stamped name shall not be employed as a substitute for, or fulfill any legal requirement otherwise mandating that the prescription be signed by the prescriber. No person, corporation, association or other entity, not licensed to issue a prescription pursuant to this title, shall wilfully cause prescription forms, blanks or facsimiles thereof to be disseminated to any person other than a person who is licensed to issue a prescription pursuant to this title.
A violation of this subdivision shall be a class B misdemeanor punishable in accordance with the provisions of the penal law. Notwithstanding any other provision of this section or any other law to the contrary, effective three years subsequent to the date on which regulations establishing standards for electronic prescriptions are promulgated by the commissioner of health, in consultation with the commissioner pursuant to subdivision three of section two hundred eighty-one of the public health law, no practitioner shall issue any prescription in this state, unless such prescription is made by electronic prescription from the practitioner to a pharmacy, except for prescriptions: A pharmacy that receives an electronic prescription from the person issuing the prescription may, if the prescription has not been dispensed and at the request of the patient or a person authorized to make the request on behalf of the patient, immediately transfer or forward such prescription to an alternative pharmacy designated by the requesting party.
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In the case of a prescription issued by a practitioner under paragraph b of subdivision ten of this section, the practitioner shall be required to indicate in the patient's health record that the prescription was issued other than electronically due to temporary technological or electrical failure. In the case of a prescription issued by a practitioner under paragraph d or e of subdivision ten of this section, the practitioner shall, upon issuing such prescription, indicate in the patient's health record either that the prescription was issued other than electronically because it a was impractical to issue an electronic prescription in a timely manner and such delay would have adversely impacted the patient's medical condition, or b was to be dispensed by a pharmacy located outside the state.
The waiver process established in regulation pursuant to paragraph c of subdivision ten of this section shall provide that a practitioner prescribing under a waiver must notify the department of health in writing promptly upon gaining the capability to use electronic prescribing, and that a waiver shall terminate within a specified period of time after the practitioner gains such capability.
Notwithstanding any other provision of law to the contrary, no outsourcing facility may distribute or dispense any drug to any person pursuant to a prescription unless it is also registered as a pharmacy in this state and meets all other applicable requirements of federal and state law. Prescriptions in both oral and written form for both controlled substances and non-controlled substances shall be included in determining whether the practitioner will reach the limit of twenty-five prescriptions.
A certification shall be submitted in advance of the twelve-month certification period, except that a twelve-month certification submitted on or before on July first,two thousand sixteen, may begin March twenty-seventh, two thousand sixteen. A practitioner who has made a certification under this subdivision may submit an additional certification on or before the expiration of the current twelve-month certification period, for a maximum of three twelve-month certifications. A practitioner may make a certification under this subdivision regardless of whether he or she has previously received a waiver under paragraphs c of subdivision ten of this section.
It shall be a class A misdemeanor for: Nothing contained in this paragraph shall be construed to prohibit the sale and dispensing of bichloride of mercury in any form, shape, or color, when combined or compounded with one or more other drugs or excipients, for the purposes of internal medication only, or when sold in bulk in powder form, or to any preparation containing one-tenth of a grain or less of bichloride of mercury; Any pharmacy to fail to properly post the list required by section sixty-eight hundred twenty-six of this article; Any pharmacy to change its current selling price without changing the listed price as provided by section sixty-eight hundred twenty-six of this article; Any person to refuse to permit access to or copying of any record as required by this article; or Any manufacturer to sell or offer for sale any drug not manufactured, prepared or compounded under the personal supervision of a chemist or licensed pharmacist or not labeled with the full name of the manufacturer or seller.
Any outsourcing facility to sell or offer to sell any drug that is not both compounded under the personal supervision of a licensed pharmacist and labeled with the full name of the outsourcing facility. Certain drugs to be clearly marked or labeled. Except as otherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug for which a prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health may be manufactured or commercially distributed within this state in tablet or capsule form unless it has clearly marked or imprinted on each such tablet or capsule in conformance with the applicable plan required by subdivision three of this section: Except as otherwise authorized in the Federal Food, Drug and Cosmetic Act, no drug for which any prescription is required by the provisions of the Federal Food, Drug and Cosmetic Act or by the commissioner of health contained within a bottle, vial, carton or other container, or in any way affixed or appended to or enclosed within a package of any kind, and designed or intended for delivery in such container or package to an ultimate consumer, shall be manufactured or distributed within this state unless such container or package has clearly and permanently marked or imprinted upon it in conformance with the applicable plan required by subdivision three of this section: Each manufacturer and distributor shall prepare and submit to the commissioner of health a proposed plan of the manufacturer or distributor, as the case may be, to have its products comply with the marking and labeling requirements of this section.
Such plan shall be in writing and shall give the respective dates by which the various products manufactured or distributed will each contain the required mark or label. The plan shall state the reasons why the projected date of compliance has been proposed and such other information deemed relevant or that the commissioner of health shall require. The commissioner may either approve the plan as proposed or, after consultation with the manufacturer or distributor, require an amendment or the commissioner may promulgate a plan for the manufacturer or distributor.
No plan or amendment to the plan shall be effective until approved or promulgated by the commissioner of health upon a finding by him that the time limitations provided for therein are reasonable and will best carry out the intendment of this section. Updated materials shall be provided as changes occur, upon the filing of an annual request. The provisions of this subdivision shall be deemed to be complied with when a prescription drug product is included in the Physician's Desk Reference.
Every person, firm or corporation violating the provisions of this section for any prescription drug product shall be guilty of an offense punishable by a fine of not less than twenty-five hundred dollars nor more than ten thousand dollars. Any prescription drug product prepared or manufactured in violation of this section shall be contraband and subject to seizure either by the state board of pharmacy or by any law enforcement officer of the state.
The provisions of this section shall not apply to any tablet or capsule which contains a controlled substance as that term is defined by article thirty-three of the public health law or which is prepared or manufactured by a pharmacist duly licensed by the state which is made by him for the purpose of retail sale from his principal place of business and not intended for resale.
The commissioner of health may exempt a particular tablet or capsule from the requirements of this section, upon application by a manufacturer, on the grounds that labeling such a tablet or capsule is unfeasible because of size or texture or other unique characteristics. As used in this section, the term "distributor" means the person, firm, corporation or other entity which is not the actual manufacturer of a prescription drug product but which distributes such product for resale under the label of such person, firm, corporation or entity.
For purposes of subdivision four "drug product" means the entire supply of the finished dosage form of the drug. Door-to-door distribution of drugs prohibited. Where any pharmacy, manufacturer, wholesaler or outsourcing facility registered by the department is damaged by fire the board shall be notified within a period of forty-eight hours, and the board shall have power to impound all drugs for analysis and condemnation, if found unfit for use.
Where a pharmacy is discontinued, the owner of its prescription records shall notify the department as to the disposition of said prescription records, and in no case shall records be sold or given away to a person who does not currently possess a registration to operate a pharmacy. Nothing in this article shall be construed as requiring the prosecution or the institution of injunction proceedings for minor violations of this article whenever the public interest will be adequately served by a suitable written notice of warning.
The executive secretary of the state board of pharmacy is authorized to conduct examinations and investigations for the purposes of this article through officers and employees of the United States, or through any health, food, or drug officer or employee of any city, county or other political subdivision of this state. Any drug, device or cosmetic that is adulterated, misbranded or may not be sold under the provisions of this chapter, may be seized on petition or complaint of the board and condemned in the supreme court of any county in which it is found.
Seizure shall be made: The article shall be seized by order of such officer. The order shall describe the article to be seized, the place where the article is located, and the officer or employee making the seizure. The officer, in lieu of taking actual possession, may affix a tag or other appropriate marking to the article giving notice that the article has been quarantined and warning all persons not to remove or dispose of it by sale or otherwise until permission for removal or disposal is given by the officer or the court.
In case of seizures or quarantine, pursuant to such order, the jurisdiction of such court shall attach upon such seizure or quarantine, and a petition or complaint for condemnation shall be filed promptly. The procedure for cases under this section shall conform as much as possible to the procedure for attachment. Any issue of fact joined in any case under this section shall be tried by jury on the demand of either party.
The court at any time after seizure and up to the time of trial shall allow by order any party or his agent or attorney to obtain a representative sample of the condemned material, a true copy of the analysis on which the proceeding was based, and the identifying marks or numbers, if any, on the packages from which the samples analyzed were obtained. Any drug, device or cosmetic condemned under this section shall be disposed of by destruction or sale as the court may direct after the decree in accordance with the provisions of this section.
The proceeds of the sale, if any, shall be paid into the state treasury after deduction for legal costs and charges. However, the drug, device or cosmetic shall not be sold contrary to the provisions of this article. After entry of the decree, if the owner of the condemned articles pays the costs of the proceeding and posts a sufficient bond as security that the articles will not be disposed of contrary to the provisions of this article, the court may by order direct that the seized articles be delivered to the owner to be destroyed or brought into conformance with this article under supervision of the secretary.
The expenses of the supervision shall be borne by the person obtaining the release under bond. Any drug condemned by reason of its being a new drug which may not be sold under this article shall be disposed of by destruction. When the decree of condemnation is entered, court costs and fees, storage and other expense shall be awarded against the person, if any, intervening as claimant of the condemned articles. In any proceeding against the board, or the secretary, or an agent of either, because of seizure, or quarantine, under this section, the board, or the secretary, or such agent shall not be liable if the court finds that there was probable cause for the acts done by them.
Adulterating, misbranding and substituting.
Dating while in pharmacy school – uherinep.cf
A drug or device shall be deemed to be adulterated: If it consists in whole or in part of any filthy, putrid, or decomposed substance; or if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch that has been certified in accordance with regulations provided in this article.
If it purports to be, or is represented as, a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or, in the absence or inadequacy of such tests or methods of assay, then in accordance with tests or methods of assay prescribed by regulations of the board of pharmacy as promulgated under this article.
Deviations from the official assays may be made in the quantities of samples and reagents employed, provided they are in proportion to the quantities stated in the official compendium. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because 1 it exceeds the standard of strength therefor set forth in such compendium, if such difference is plainly stated on its label; or 2 it falls below the standard of strength, quality, or purity therefor set forth in such compendium if such difference is plainly stated on its label, except that this clause shall apply only to such drugs, or classes of drugs, as are specified in regulations which the board shall promulgate when, as applied to any drug, or class of drugs, the prohibition of such difference is not necessary for the protection of the public health.
Whenever a drug is recognized in both the United States pharmacopoeia and the homeopathic pharmacopoeia of the United States, it shall be subject to the requirements of the United States pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the homeopathic pharmacopoeia of the United States and not to those of the United States pharmacopoeia.
If it is not subject to the provisions of paragraph b of this subdivision and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. If it is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength or substituted wholly or in part therefor. If it is sold under or by a name not recognized in or according to a formula not given in the United States pharmacopoeia or the national formulary but that is found in some other standard work on pharmacology recognized by the board, and it differs in strength, quality or purity from the strength, quality or purity required, or the formula prescribed in, the standard work.
Misbranded and substituted drugs and devices. A drug or device shall be deemed to be misbranded: If its labeling is false or misleading in any particular. Furthermore, what really makes this app stand out is its medical calculators, assisting pharmacy technician students with their studies. The Skyscape Medical Library app features a large library of medical resources for pharmacy technicians. It includes general and specific drug information, calculators to determine dosages, clinical information, algorithms, flowcharts, and medical topics to read about.
The app is updated regularly, and is free to download. Medscape is a comprehensive drug referencing pharmacy technician app. It allows the user to search for specific drugs with 8, brands to choose from , as well as OTC drugs, herbal supplements. The Drug Interaction Checker is a built-in feature that can deter mild to severe interactions, ensuring patient safety and accurate recording. There's also a disease reference feature which contains information about over 4, diseases and clinical conditions.
These can be cross referenced with the appropriate drugs. The app also contains the latest policies and procedures and medical news. Reviewed by the Harvard Medical School, all of the app content is precise and up-to-date, with symptom checkers, disease information, and drug policy data. Microemedex Drug Information is a highly comprehensive database of drug, disease, and policy information for pharmacy technicians. It includes precautions and contradictions, dosages, latest drug news, and pregnancy and breastfeeding information, as well as a database of thousands of drugs and medical conditions.
Pharmacy technicians and pharmacy technician students can benefit from an efficient app to refer to for those all-important answers. It is now possible to complete dosage calculations, check drug interactions, and keep up with essential pharmacy related news from your mobile phone and make important pharmaceutical decisions within seconds. Contact Us Live Chat. Fortunately, pharmacy technician apps can produce this data, so that critical decisions can be made in a safe and informed way. Here is a list of the best pharmacy technician apps for Android and iOS.
Rx Shortages This is a free, informative mobile app for pharmacy technicians.