Lec 8-9 (week 4)

List the license requirements for an in-state pharmacy in Wisconsin

• Submit an application with the location, floor plan, name and address of the owner, name of managing pharmacist

• Submit a self inspection which is confirmed by audit within 1 year

• Pay the fee

Describe the prohibited actions for a place where pharmacy is practiced without a License

• Without a license, the business may not operate as a pharmacy nor use the terms “pharmacy, drugstore, apothecary or any other term or symbol with a similar meaning

 Define the professional service area

• The area of a pharmacy in which prescriptions are compounded or dispensed, hypodermic needles, syringes, poisons and schedule V controlled substances are available, or where patients are consulted

Explain the requirements for securing and closing the professional service area

• When the professional service area is closed, it must be secured and locked:

  1. a sign posting the hours of professional services must be posted

  2. The manner in which the phone is answered cannot imply professional services are available 

List the situations in which a pharmacy must obtain a new license

• Change in ownership

• Change in location

• When a new pharmacy is opened

Describe the standards for sanitation, equipment, storage, temperature, humidity, and security for a pharmacy

• Sanitation: 

  • clean and orderly, 

  • sink with hot and cold water, 

  • Detergent,

  •  waste disposal container

• Equipment: 

  • appropriate equipment for area of practice, 

  • Latest and immediately accessible version of federal and state pharmacy laws

  • References appropriate to the individual pharmacy practice

  • Telephone number of a poison center 

• Storage: 

  • secure, 

  • neat, 

  • Clean,

  • Orderly,

  • controlled substances locked

• Temperature & Humidity: continuously monitored, min and max values recorded once each business day

• Security: centrally monitored alarm system, or one approved by the board

Describe how an out-of-state pharmacy obtains licensure in Wisconsin

• Submit application with 

  • Location

  • Name and address of owner

  • Name of managing pharmacist 

  • Statement of knowledge regarding WI laws

  • Proof of licensure in home state

  • Pay fee

Identify the license renewal date and frequency for pharmacies licensed in Wisconsin

• In-state and out-of-state pharmacies renew their license every two years; their renewal date is June 1st of even years (same as for pharmacists)

manufacturing

making, assembling, processing or modifying devices, or mixing, producing or preparing drugs in dosage forms by encapsulating, entableting or other process, or packaging, repackaging or otherwise changing the container, wrapper or label of any package containing a drug or device in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.

manufacturer

Person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the definition of “manufacturer” under the FDA’s regulations and interpreted guidances implementing the federal prescription drug marketing act

distribute

To deliver, other than(aka not) by administering or dispensing

deliver

The actual constructive or attempted transfer of a drug or device from one person to another

administer

The direct application of a vaccine or a prescribed drug or device to the body

dispense

To deliver a prescribed drug or device to an ultimate user- including the compounding, packaging or labeling necessary to prepare the prescribed drug or device for delivery

wholesale distribution

Distribution of a prescription drug to a person other than a consumer or patient

wholesale distributor

Person engaged in the wholesale distribution of prescription drugs

third-party logistics provider

A person that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services (but don’t own the drugs)

List the license requirements for a manufacturer

manufacturer

Submit an application on a form provided by the board Pay the fee specified in statute Pass inspection Register with the FDA Register with DEA if applicable to obtain licensure in WI

List the license requirements for a , wholesale distributor,

wholesale distributor

Submit an application (including extensive information about a designated representative)  Pay a fee Pass inspection Provide surety bond Be registered with the DEA if applicable to obtain license from WI A manufacturer who also distributes is exempt from the requirement of license as a distributor

List the license requirements for a third-party logistics provider

third-party logistics provider

Submit a application similar to a wholesale distributor Pay a fee Pass inspection

Recognize when a pharmacy is engaging in wholesale distribution and must obtain a wholesale distributor license

Recognize that a home medical oxygen provider is licensed by the Pharmacy Examining Board and explain why this is the case

Because medical oxygen is considered a prescription drug

Identify the license renewal date and timeframe for manufacturers, distributors, and home medical oxygen providers

Renew their license every 2 years by June 1st of even years