The Pharmacy Ownership/staffing Requirements

Question 1

RPh-Tech Ratio? Different by Setting?

Answer 1

1:2 —> 1 RPh to a maximum 2 technicians

May increase number of support staff based on the following scenarios

● 1:3 ratio provided that at least 1 of the 3 personnel is a certified tech or intern

● 1:4 ratio provided that at least 2 of the 4 personnel is a certified tech or intern

Question 2

What are the fees to apply for A PHARMACY license

Answer 2

application: $525

CS application: $225

Question 3

Who can own A PHARMACY

Answer 3

anyone

EXCEPT: a provider with prescriptive authority

Question 4

Application for ownership of A PHARMACY must include

Answer 4

1. The scheduled hours of the pharmacy
2. Blueprint plans for pharmacy
3. MA CS registration
4. MA certificate of fitness registration

Question 5

Application for ownership of A PHARMACY, opened by a corporation

Answer 5

1. Scheduled hours the pharmacy will be open
2. Blueprint plans for pharmacy
3. MA CS registration
4. MA certificate of fitness registration

AND

● Copy of corporation’s articles of organized (signed by secretary of MA)

● Copy of corporation’s foreign corporation certificate (if out of state

● Statement of each officer/director’s name, address and position

● D/b/a (doing business as)

● If privately owned – name and address of stockholders with stock type and amount

Question 6

When there is going to be a change in ownership, the application to the BOP must include

Answer 6

1. name of new owner
2. bill of sale

—-if new owner is corp

3. Copy of corporation’s articles of organized (signed by secretary of MA)
4. Copy of corporation’s foreign corporation certificate (if out of state)
5. Statement of each officer/director’s name, address and position
6. D/b/a (doing business as)

——if new owner is corp that is privately owned

3. name and address of stockholders with stock type and amount

Question 7

Requirements for change in MOR (PIC)

Answer 7

1. MOR must report in writing to BOP within 10 days regarding commencement or termination of employment

2. Application to BOP must include:

–CS (C2-5) inventory signed by both outgoing MOR and incoming MOR

–If outgoing MOR is unable (due to death, serious illness or termination of license for inappropriately handling Controlled Substances) then a staff RPh may be authorized to sign off on inventory if BOP was notified

3. The pharmacy permit and certificate of fitness (if applicable)

Question 8

Can Syringes Be Dispensed Without Prescription? Logging Requirement?

Answer 8

May be sold by a pharmacist** or **wholesale druggist,

wholesale druggist = a manufacturer of or dealer in surgical supplies without a prescription.

There are no age or quantity limitations

Question 9

Maximum amount of pseudoephedrine that can be sold …

in a day?

in 30 days?

in 30 days via mail ?

Answer 9

3.6 g

9 g

7.5 g

Question 10

Training required for staff of pharmacy selling pseudoephedrine

Answer 10

Sellers must complete a self-certification process with the DEA that includes training their employees and must recertify annually

Question 11

Purchase requirements for pseudoephedrine

Answer 11

No age

Pt must show ID

Question 12

Requirements of record keeping with pseudoephedrine sales

Answer 12

any purchase of pseudoephedrine must be logged - EXCEPT single sales package containing 60 mg or less DO NOT require to be logged

log can be electronic or written

must be kept for 2 years

log of each sale must include:

• purchasers name, address, signature
• product name
• quantity sold
• date and time

Question 13

where is pseudoephedrine located in the pharmacy?

Answer 13

behind the counter

Question 14

Rules about “nonliquid” pseudoephedrine

Answer 14

nonliquid dosage forms (tabs) containing pseudoephedrine must be in blister backs and cannot have >2 tabs (dosage units) per blister.

where blister packs cannot be used - product must be packaged in unit dose packets