Prescription Drug Manufacturers/Wholesalers
Abstracts of NH State Pharmacy Laws & Rules applicable to Pharmaceutical Manufacturers/Wholesalers doing business in the State of New Hampshire
Definitions In this chapter:
VIII. "Manufacturing" means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by large volume extraction from substances of natural origin, or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. "Manufacturing" also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists to anyone other than a patient via a prescription, practitioners, or other persons.
XXI. "Wholesaler" means a person with facilities in or outside this state who obtains drugs for distribution or delivery to persons other than consumers.
Licensing of Manufacturers and Wholesalers Required
I. No person shall manufacture legend drugs or controlled drugs as that term is defined in RSA 318-B:1, VI and no person as a wholesaler or distributor shall supply the same without first having obtained a license to do so from the board. Such license shall expire annually on June 30. An application together with a reasonable fee as established by the board shall be filed annually on or before July 1.
II. No license shall be issued under this section unless the applicant has furnished proof satisfactory to the board of pharmacy:
(a) That the applicant is of good moral character or, if that applicant is an association or corporation, that the managing officers are of good moral character.
(b) That the applicant has sufficient land, buildings, and such security equipment so as to properly carry on the business described in his application.
III. No license shall be granted to any person who has within 5 years been convicted of a violation of any law of the United States, or of any state, relating to drugs, as defined in this chapter or RSA 318-B, or to any person who is a drug-dependent person.
IV. Any person licensed pursuant to this section is subject to the provisions of RSA 318:29.
Licensing of Manufacturers and Wholesalers Required
No person shall manufacture controlled drugs, and no person as a wholesaler shall supply the same, without first having obtained a license to do so as provided in RSA 318:51-a.
Sale by Manufacturer or Wholesaler
A duly licensed manufacturer or wholesaler may sell and dispense controlled drugs only to any of the following persons, and only on official written orders:
I. To a manufacturer, wholesaler, or pharmacist.
II. To a practitioner.
III. To that person in each hospital designated as in charge of controlled drugs, but only for use by that hospital, pursuant to the restrictions of the board of pharmacy license.
IV. To that person in each laboratory designated as in charge of controlled drugs, but only for use in that laboratory for scientific and medical purposes.
V. To a person in the employ of the United States government or of any state, territorial, district, county, municipal, or insular government purchasing, receiving, possessing, or dispensing controlled drugs by reason of his official duties, upon an exempt official order form as required by the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended.
VI. To a master of a ship or a person in charge of any aircraft upon which no physician is regularly employed, or to a physician or surgeon, duly licensed in some state, territory, or the District of Columbia to practice his profession, or to a retired commissioned medical officer of the United States Army, Navy, or Public Health Service employed upon such aircraft, or to a physician, surgeon, or retired commissioned medical officer of the United States Army, Navy, or Public Health Service employed upon such ship or aircraft only in pursuance of a special order form approved by the Attorney General of the United States.
VII. To a person in a foreign country if the provisions of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, are complied with.
NH Code Of Administrative Rules
PART Ph 309 STANDARDS OF PRACTICE FOR MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS
Ph 309.01 License Required
(a) No person shall manufacture or act as a wholesale distributor of prescription drugs or prescription devices without first obtaining a license to do so from the board according to RSA 318:51-a. No license shall be issued or renewed for a manufacturer or wholesale drug distributor unless the same shall be operated in a manner prescribed by law and according to the rules adopted by the board of pharmacy with respect thereto.
(b) Separate licenses shall be required for each manufacturing and distribution site owned or operated by a manufacturer or wholesale distributor. Provided however, that an agent or employee of any licensed manufacturer or wholesale distributor shall not be required to be licensed under this section and may lawfully possess prescription drugs and devices if he is acting in the usual course of his business or employment.
(c) The board shall provide, on an annual basis, a license renewal form to all licensed manufacturers and wholesale distributors of prescription drugs and devices.
(d) The prescribed fee for original and annual renewal licenses for manufacturers and wholesale distributors of prescription drugs and devices shall be $250.
Ph 309.02 Obtaining and Filing a License Application
Applications for licensure of manufacturers, wholesalers and distributors may be obtained from, and shall be filed at, the board office, identified in Ph 103.03.
Ph 309.03 Application Contents
The applicant for licensure shall supply, on form Ph A-4, at least the following information:
(a) Name of the company;
(b) The address of the actual location where manufacturing, wholesaling and distribution occurs;
(c) Identification of ownership; and
(d) Name and address of the person responsible for licensing.
Ph 309.04 Storage Conditions
All facilities at which prescription drugs are repackaged, wholesaled, stored, held, sold, offered for sale, exposed for sale, or kept for sale shall provide storage areas that ensure proper lighting, ventilation, temperature, sanitation, humidity, equipment, and security conditions. All prescription drugs or chemicals shall be stored at appropriate temperatures per label requirements or in compliance with official United States Pharmacopeia (USP) compendium requirements to help ensure that the identity, strength, quality, and purity of the products are not affected. If no temperature requirements are listed, prescription drugs may be stored at room temperature in compliance with U.S.P. definition for room temperature. A separate storage section shall be provided for prescription drugs that are deteriorated, outdated, misbranded, or otherwise adulterated.
Ph 309.05 Facilities
(a) All buildings in which prescription drugs are wholesaled, repackaged, stored, held, sold, offered for sale, exposed for sale, or kept for sale shall be of suitable size, construction, and location to facilitate cleaning and maintenance.
(b) Buildings shall meet all applicable federal, state, and local standards. A facility shall not be located in a residence. All facilities shall be located in an area that is commercially zoned.
(c) A wholesale drug distribution facility shall notify the local police department or other appropriate law enforcement agency that it is a distributor of prescription drug products and controlled substances.
Ph 309.06 Security
(a) Each wholesale drug distribution center shall be equipped with an internal alarm system to detect entry after hours. The alarm system shall be of the type that transmits a signal directly to a central station protection company, to a local or state police agency that has a legal duty to respond, a 24 hour control station operated by the wholesale drug distributor.
(b) Manufacturers and wholesale drug distributors shall ensure that all access from outside their premises is secure. This shall include, but not be limited to, the installation of adequate lighting at the outside perimeter of the premises.
(c) Internal security policies shall be developed to provide protection against theft by personnel.
Ph 309.07 Recordkeeping
(a) Inventories and other records of transactions regarding the receipt and disposition of prescription drugs shall be maintained and made available for inspection by the board's inspectors for a period of 2 years.
(b) Records may be kept at a central location rather than at each distribution center, but records shall be made available for inspection within 72 hours of request by the board's inspectors.
Ph 309.08 Inspections
(a) Inspections shall be performed by the board's inspectors and be conducted at the request of the board.
(b) Inspections shall be conducted during normal business hours, and notification of inspections shall be given no less than 48 hours in advance.
(c) Information that is considered to contain trade secrets or which might be proprietary in nature shall be protected from outside disclosure.
Ph 309.09 Written Policies and Procedures
(a) Written policies and procedures shall be developed by management personnel to assure that the manufacturer and wholesale drug distributor prepares for, protects against, and handles crisis situations that affect the security or operation of the facility. Such crises may include fires, floods, or other natural disasters, and situations of local, state or national emergency.
(b) Written policies and procedures described in (a) above shall also provide for:
(1) The management and correction of all errors or inaccuracies in inventories;
(2) The assurance that any outdated stock, or any stock with an expiration date that, in the wholesale drug distributor's view, does not allow sufficient time for repacking or resale, shall be prepared for return to the manufacturer or otherwise destroyed; and
(3) The control over the shipping and receiving of all stock within the operation.
(c) A copy of the policies and procedures, or sections thereof, shall be made available to the board upon request.
Ph 309.10 Returned Goods
A wholesale operation shall maintain a procedure for the proper handling and disposal of returned goods.
Ph 309.11 Handling Recalls
(a) A wholesale operation shall maintain a written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover all recalls and withdrawals of prescription drug products due to:
(1) Any voluntary action on the part of the manufacturer;
(2) The direction of the Food and Drug Administration, or any other federal, state or local governmental agency; and
(3) Replacement of existing merchandise with an improved product or new package design.
Ph 309.12 Responsibility for Operation
A wholesale drug distribution operation shall maintain a list of principals and persons in charge including officers, directors, or primary stockholders and their qualifications.
Ph 309.13 Compliance with State and Federal Law
(a) All manufacturers, wholesalers and distributors shall comply with all applicable state and federal laws and regulations.
(b) All manufacturers, wholesalers and distributors, doing business in New Hampshire, shall, before shipping or distributing any prescription drug, verify that the recipient is properly licensed to receive and possess such drugs.
(c) All manufacturers, wholesalers and distributors, licensed and doing business in the state of N.H., shall not provide unsolicited controlled drug samples to licensed practitioners.
(d) A manufacturers license shall allow for the direct wholesaling or distribution of such drugs to other licensed or authorized recipients.
(e) A duly authorized agent of a manufacturer, wholesaler or distributor licensed in this state, may possess and distribute potent or prescription drugs to individuals who may lawfully possess such drugs as may be necessary to further the licensed activity of the manufacturer, wholesaler or distributor.
(f) Indirect sale or distribution shall include, but not be limited to:
(1) Solicitation, in this state, by manufacturers, wholesalers or distributors sales representatives;
(2) Telephone solicitations to customers located in this state by manufacturers, wholesalers or distributors sales representatives;
(3) Solicitation of customers located in this state by mail or by the use of media advertising which has a significant circulation in the state of New Hampshire.
Ph 309.14 Violations
(a) No manufacturer or wholesaler shall distribute prescription drugs directly to a consumer or a patient, or operate in such a manner as to endanger the public health.
(b) Any person who manufacturers, wholesales, or otherwise distributes prescription drugs, according to RSA 318:51-a and he provisions of Ph 309, shall be subject to disciplinary action as provided in RSA 318:29.