DEPARTME T OF BEALTR AND IJUMA . SERVICES 

FOOD AND DRUG ADMlNJSTRATlON 

DISTRICT AO DRESS ANO PI-IONE NUMBER 

8050 Marshall Drive, Suite 205 

Lenexa, KS 66214 

913-495-5100 

OATE(SJ OF INSPECTION 

09/26/2022 - 09/28/2022 

FE NUMBER 

3012814943 

NAME AND Tln.E OF INDIVICUAL TO WHOl,IJ REPORT ISSUED 

Jamie L. Berglru1d, Phann D. RPH, Pharmacist-in-Charge 

FIRM N,,ME 

MSLS LLC dba The Medicine Shoppe 

STREET ADDRESS 

1405 NE Douglas 

CITY, STATE, ZIP CODE, COUNTRY 

Lees Su.llllWt, MO 64086 

TYPE ESTABLISHMENT INSPECTED 

Producer of Non-Sterile Drug Products 

This document lists ob, ervations made by the FDA representative( ) during the inspection of your facility. They are inspectional 

observations. and do not represent a final Agency determination regarding your compliance. If you have an o~jection regarding an 

observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection o.r 

action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Lfyou have any 

questions, please contact FDA at the phone number and address above. 

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: 

OBSERVATION l 

Non-microbial contamination was observed in your production area. 

Speci£cally, 

On 09/26/2022, the technician was observed producing approximatelylb><4i hom1onal and non-hormonal 

non-sterile human drug products (i.e. Progesterone 75mg capsules, Rx number I (b) (6) ,, expires 

03/25/2023) and one non-sterile animal drug product (Methimazole l .25mg/0. lmL in Lipoderm cream 

6mL, Rx number( (b) (6) J expires 12/25/2022, intended species feline) in the drug compounding lab 

during which the following were observed: 

• Apparent residue build-up around and behind the sink where all glassware and utensils used in 

production of non-sterile human and acimal drug products are cleaned. Additionally, on 

09/26/2022 your technician was observed using the glass slab that was stored berund the sink to 

produce non-sterile human drug products (i.e. Ketoprofen/Lidocrune 20/5% cream, batch number 

092622KETO expires 03/25/2023). Your technician did not clean the glass slab prior to use. 

• Apparent thick, black residue build-up on the return vent located in the ceiling . 

• Apparent residue build-up behind the(0) (4) magnetic stir plates used to mix hormonal and nonhormonal non-sterile human and animal drug products, 

OF THIS PAGE ln.r.t1 

r EMPLOYEE($) NAME AND TITLE (Print or Type) DATE ISSUED 

SEE REVERSE ::;'~ ~ Lauren N. Howard, 1nvestigator 09/2 8 /2022 

7) ~1. Jill J_ Tillman, Investigator 

7r 

4" l'ORM FDA 483 (09/08} PRgVJOUS EDITION OBSOLETE lNSPl<:CTIONAL OBSERVATIONS PAGE l Of. 4 PAGES 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINlSTRATION DISTI<ICT ADDR ESS AND PHONE NUMBER DATE{S) OF INSPECTION 

8050 Marshall Drive. Suite 205 09/26/2022 - 09/28/2022 

Lenexa, KS 66214 FEI NVM6S'! 

913-495-5100 3012814943 

NA.MC AND TITI.E OF INDlVfDUAL TO \\!HOM REPORT lSSUED 

Jamie L. Bergland, Pbarm D, RPH, Pharmacist-in-Charge 

FlRMl>lAME STREET ADDRESS 

MSLS LLC dba The Medicine Shoppe 1405 NE Douglas 

CITY, ST,',TE, ZlP CODI;, COUNTRY TYPE ESTABLISHMENT lNS~EO 

Lees Summit, MO 64086 Producer of Non-Sterile Drug Products 

OBSERVATION 2 

You produced hazardous drugs without providing adequate containment, segregation, cleaning of work 

surfaces and cleaning of utensils to prevent cross-contamination. 

Specifically, 

a. On 09/26/2022 in the drug compounding lab, your technician was observed running through the 

b 4) mill lbJ <41' commercially available non-pharmaceutical grade cleaning agents that may 

leave residues and using approximately (5) (4) of water to rinse the cleaning agents off 

the mill. The following non-sterile human drug products are processed through the non-dedicated 

mill: 

• all topical lidocaine powder containing mixtures 

• all topical gabapentin powder containing mixtures 

• salicylic acid containing cream (bJ (4) batched cream) 

• all topica1 ibuprofen powder containjng mixtures 

b. According to your technician, clear plastic bowls used to cover pre-weighed hormonal and nonhormonal human and animal drug powders are never cleaned unless visible residue is detected on 

them. On 09/26/2022, we observed bowls being used to cover pre-weighed hormonal powders 

for trouches which had visible residue on them. Your technician stated if the bowls are cleaned, a 

non-pharmaceutical grade detergent is used. The following trouches were compounded for 

hwnan use: 

• Estrio1/Estradiol 2mg/Progesterone 175mg/Testosterone l .25mg/DHEA 

1.25mg, Rx number (b) (6) , expires 03/25/2023, picked up by patient 

EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 

SEE REVERSE Lauren N. Howard, Investigator 0 9/ 28/2022 

OF THIS PAGE Jill J. Tillm an, Investigator 

~·01.11\l FOA 483 (09/08) l'IIEV!OUS EOrTJON OOSO!,ET!l lNSP&CTrON AL OBSERVA TIO S l'AGB 2 OF 4 PIIGE 
DEPARTMENT OF HEALTH AND ffiJJ\>lAN SERVICES 

l'OODAND DRUG ADMTNISTRAT[ON 

DISTRICT ADDREGS AND PHONE NUMBER OA Tl;C(SJ OF INSPECTION 

8050 Marshall Drive, Suite 205 09/26(2022 - 09/28/2022 

Lenexa, KS 662 I 4 FEINUMaER 

3012814943 913-495-5100 NAME AND TITLE OF INDIVIDUAL TO WHOM RE-T ISSUED 

Jamie L. Bergland, Phann D, RPI-I, Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

MSLS LLC dba The Medicine Shoppe 1405 NE Douglas 

CITY, ST A TE, ZIP CODE, COUNTRY TYF'E ESTABLISHMENT INSPECTED 

Lees Summit, MO 64086 Producer of Non-Sterile Drug Products 

• Estriol/Estradiol a(b) (4) }) l.85mg/Progesterone 185mg/Testosterone 0.25mg/DHEA 

1 mg/Pregnenolone 25mg, Rx number (o) (6) . .i , expires 02/02/2023, picked up by patient 

• Estradiol lmg/Progesterone 200mg/Testosterone 3mg, Rx number! (b) (6) expires 

03/25/2023, picked up by patient 

• Estriol/Estradiol [ (b) (4) J) 3.75mg/Progesterone 130mg/Testosterone l.Smg/DHEA 

l0mg/Pregnenolone 50mg, Rx number[ (b) (6) I expires 03/25/2023, picked up by 

patient 

• Progesterone 200mg/Testosterone 0.5mg, Rx( (b) (6) !, expires 03/25/2023, picked up by 

patient 

• Estriol/Estradioll (o) (4) 0.75mg/Progesterone l0Omg/Testosterone 0.3mg/DHEA 

1mg, Rx number [ (b) (6) , -expires 02/02/2023, picked up by patient 

C. To clean all non-dedicated utensils and glassware used to produce non-sterile hormonal and nonhormonal human and animal drug products, your phannacy is using a commercially available 

nou-phannaceutica1 grade detergent that may leave residues or not be adequately rinsed from the 

utensiJs and glassware. Additionally, a deactivating agent is not used for non-dedicated utensils 

and glassware used to produce both hormonal and non-hormonal drug products to prevent crosscontamination. On 09/26/2022, in the drug compounding lab, while your technician was 

producing Estriol/Estradiol (I (o) (4) l 3.75mg/Progesterone 130mg/Testosterone l.5rng/DHEA 

1 0mg/Pregnenolone 50mg trouches, Rx number~b) (4). (b) (6> expires 03/25/2023, the glassware 

being used to mix and dissolve the drug powders had an apparent residue on it. 

OBSERVATION 3 

You used a non-pharmaceutical grade component in the formulation of a drug product 

EMPLOYEE($) NAME AND TITLE (Print or Type) DATE ISSUED 

SEE REVERSE Lauren N. Howard, Investigator 09 / 28 / 2022 

OF THIS PAGE I ~p·~ 

/r- q Jill J. Tillman, Investigator 

V 

FORM FDA 433 (09108} PREVlOUS EDmON OllSOLe'IB lNSPECTlONAL OBSERVATIONS PAGE 3 OF 4 PAGES 
RVICES 

00D AND DRUG ADMINISTRATION 

01\TE(S) OF INsPECTION 

8050 Marsh 11 Dri e. Suite 205 09/26/2022 - 09/28/2022 

Lenexa., KS 662 14 FEI NUM8Efl 

913-495-5 I 00 JO 2814943 NAME AND Trrt.E Of' INOIVIOUAL TO \M-!OM REPORT ISSUED 

Jamie L. Ber land. Phann D, RJ>H. Pharmacist-in- ,harge 

FIR.liA N.A.ME 

MSLS L dba 1 he Medicine Shoppe 1405 NE DouJ 

CITY. STA~ lJP CODE. COUNTRY TVPE ESTABLISHMEHT INSl'ECTED 

0 64086 

Specifically 

On 09/26/2022, your pharmacy produced Triamcinolone 0.1 % Rin .fi r human use, Rx nurn r 

(l5) (6) expires 10/26/2022 using (b) (4) batch number b) (4)1. The label for the (b) (4) 

tate it is pharmaceutical grad ( b) ( 4) Additionally th label in part states the source of 

(15)(4) 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) NAME AND TITL (Print or Type) 

Lauren N. Howard, lnvestigato.r 

Jill J. Tillman, lnvestigator 

DATE ISSUED 

09/28/2 02 2 

PREVIOUS EOITfON oeso.m lNSPt:CTIO AL OBS£RVAT10 S l'AuE OF 4PA 
The observations of objectionable conditions and practices listed on the front of this form 

are reported: 

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 

2. To assist firms inspected in complying with the Acts and regulations enforced by the 

Food and Drug Administration. 

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: 

"Upon completion of any such inspection of a factory, warehouse, consulting 

laboratory, or other establishment, and prior to feaving the premises, the officer or 

employee making the inspection shall give to the owner, operator, or agent in charge a 

report in writing setting forth any conditions or practices observed by him which, in his 

judgment, indicate that any food , drug, device, or cosmetic in such establishment (1) 

consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been 

prepared, packed, or held under insanitary conditions whereby it may have become 

contaminated with filth, or whereby it may have been rendered injurious to health. A copy 

of such report shall be sent promptly to the Secretary."