Abstracts Of NH State Pharmacy Laws & Rules Applicable To Pharmaceutical Manufacturers/Wholesalers Doing Business In The State Of NH   RSA 318:1 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.

 

RSA 318:51-a

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.

 

RSA 318-B:3

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.

 

RSA 318-B:5

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 the provisions of Ph 309, shall be 
subject to disciplinary action as provided in RSA 318:29.